A Randomized, Multi-center, Open-label, Controlled, In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days
Phase: PHASE2
Conditions: Healthy
Sponsor: Cerus Corporation

 
Cerus Corporation 
1220 Concord Avenue, Concord, CA US 94520 
T 925 288 6000 
F 925 288 6001 
cerus.com 
 
 
 
 
 
 
A Randomized, Multi-center, Open-label, Controlled, In 
Vivo Study to Assess the Recovery and Survival of 
Radiolabeled Autologous INTERCEPT Apheresis 
Platelet Components Suspended in 100% Plasma Stored 
for up to 7 Days 
 
 
Protocol CLI 00127, Version 5.0 
September 16, 2020 
 
 
NCT04022889 
 
 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
CONFIDENTIAL AND PROPRIETARY 
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Cerus Corporation considers this document to be confidential and not subject to 
disclosure without express written consent from Cerus Corporation. 
PROTOCOL 
 
TITLE: 
A Randomized, Multi-center, Multi-Stage, 
Controlled, In Vivo Study to Assess the Recovery 
and Survival of Radiolabeled Autologous 
INTERCEPT Apheresis Platelet Components 
Suspended in 100% Plasma Stored for up to 7 Days  
 
SPONSOR: 
Cerus Corporation 
1220 Concord Ave 
Suite 600 
Concord, CA 94520 
(925) 288-6000 
Protocol number: 
CLI 00127 
IDE number: 
BB-IDE 6200 
Medical Officer: 
Richard J. Benjamin MD, PhD, FRCPath 
Chief Medical Officer 
Cerus Corporation 
(925) 288-6020 
 
Medical Monitor: 
Tanya O’Neal, MD 
Sr. Director, Clinical Development & Product Safety 
Cerus Corporation 
(925) 288-6198 
 
 
 
Date: 
September 16, 2020 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
1.0 
SYNOPSIS 
Name of Sponsor/Company: 
Individual Study Table  
Referring to Part  
of the Dossier 
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Authority  
 Use only) 
CERUS CORPORATION 
Name of Finished Product:   
Volume: 
 
Not applicable 
Name of Active Ingredient:  
Page:  
 
Platelets treated with the INTERCEPT 
Pathogen Reduction System Suspended in 
100% Plasma and stored for up to 7 days 
Title of 
Study:  
CLI 00127: A Randomized, Multi-center, Open-label, Controlled, In Vivo 
Study to Assess the Recovery and Survival of Radiolabeled Autologous 
INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma 
Stored for up to 7 Days 
Investigators / Study 
Sites:  
Jose Cancelas-Perez, MD, PhD (Hoxworth Blood Center)  
Moritz Stolla, MD, PhD (Bloodworks Northwest Research 
Institute) 
Studied period (years): 
  Date of first enrollment: TBD 
  Date of last completed: TBD 
Phase of development:  2 
Objectives:  
The principle objective of this study is to evaluate the hypothesis that INTERCEPT Platelets in 
100% plasma stored for 5 or more days (up to 7 days) after apheresis collection retain 
sufficient viability for therapeutic transfusion efficacy. The post-infusion recovery and survival 
of autologous radiolabeled 7 day INTERCEPT platelets (Test) stored in 100% plasma will be 
measured in comparison to “fresh” autologous radiolabeled platelets (Control) according to 
FDA guidance for platelet testing (FDA 1999) in Stage 2 of this study protocol. 
A secondary objective is to compare the recovery and survival results for Test platelets 
prepared for radiolabeling using the procedures outlined by the Biomedical Excellence for 
Safer Transfusion Collaboration (BEST, Appendix B) or a variation of the BEST procedure 
(referred to as Variant 1, Appendix C) in Stage 1 of this study protocol. Cerus has 
demonstrated that the Variant 1 method, which does not incorporate an initial soft spin in the 
presence of ACD-A, results in improved in vitro platelet recovery and quality during 
preparation for radiolabeling compared to the BEST procedure. This comparison will evaluate 
the hypothesis that preparation methods prior to radiolabeling may influence in vitro quality of 
the radiolabeled platelets and post-infusion viability outcomes. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
Methodology: 
Study Design 
The study will be performed in two stages (Table S-1). Stage 1 is a randomized, 2-period 
crossover design. Test platelets stored for 7 days will be radiolabeled based on either the BEST 
or Variant 1 methods (depending on the period and randomization scheme for the Test 
platelets) for 12 healthy subjects.  The recovery and survival for Test platelets prepared with 
the BEST and Variant 1 methods will be compared with each other and against the fresh 
platelet Control. With agreement from the FDA (BQ200481, July 8, 2020), completion of 
Stage 1 is not required. 
Stage 2 is a single arm design.  Test platelets from 24 healthy subjects, stored for 7 days, will 
be prepared for radiolabeling following the Variant 1 methodology.  The recovery and survival 
for Test platelets will be compared against the fresh platelet Control. Stage 1 subjects with 
evaluable Variant 1 method data will contribute to the requirement of the 24 subjects for Stage 
2. 
For both stages, the study population will consist of healthy subjects who meet the FDA, 
AABB, and site-specific research donor eligibility criteria for apheresis platelet donation.  
Apheresis platelets will be collected in 100% plasma on the Trima Accel® Automated Blood 
Collection system.  
Each study apheresis collection will be processed using the INTERCEPT Blood System for 
Platelets. Platelet components containing 3.0 to 7.9 x1011 platelets in 300 to 420 mL of plasma 
will be processed using the INTERCEPT Dual Storage (DS) set.  The INTERCEPT process 
will begin on either the day of collection (Day 0) or the day following donation (Day 1); 
illumination must occur within 24 hours after the end of collection. Test platelets components 
will be stored for up to 7 days, from day of collection, in 100% plasma.   
During each stage samples for in vitro platelet testing will be collected prior to INTERCEPT 
treatment (Day 0/1), post INTERCEPT treatment and at the end of storage, Day 7 (see In vitro 
evaluation of platelets below).  
At the end of storage, an aliquot of Test platelets will be aseptically removed from each 
subject’s INTERCEPT platelet storage container for preparation of samples for radiolabeling 
using either the BEST (Stage 1) or Variant 1 (Stages 1 and 2) methodology. The in vitro 
quality of the Test platelet sample used for radiolabeling will be assessed prior to and 
following the pre-radiolabeling platelet sample preparations. The indices to be measured in 
Stage 1 are volume, pH22°C, CD62P, platelet count, red blood cell (RBC) count and white 
blood cell (WBC) count.  Assessments of these indices will enable the determination of platelet 
processing recovery for each sample preparation method and evaluation of RBC and WBC 
contamination in samples prior to radiolabeling. In Stage 2 platelet processing recovery during 
sample preparation will be calculated from volume and platelet count and pH22°C, will be 
measured in the sample prior to radiolabeling. 
On the day corresponding to the end of storage for the Test component, healthy subjects will 
return to the site, and 43 mL of whole blood (WB) will be drawn into a syringe containing 
9 mL of Anticoagulant Citrate Dextrose Solution, Formula A (ACD-A). The sample will be 
used to prepare Control platelets following the BEST methodology. Test and Control platelets 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
CONFIDENTIAL AND PROPRIETARY 
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Cerus Corporation considers this document to be confidential and not subject to 
disclosure without express written consent from Cerus Corporation. 
Name of Sponsor/Company: 
Individual Study Table  
Referring to Part  
of the Dossier 
(For National 
Authority  
 Use only) 
CERUS CORPORATION 
Name of Finished Product:   
Volume: 
 
Not applicable 
Name of Active Ingredient:  
Page:  
 
Platelets treated with the INTERCEPT 
Pathogen Reduction System Suspended in 
100% Plasma and stored for up to 7 days 
will be randomly radiolabeled with either 51Cr (approximately10-30μCi) as sodium 
radiochromate (Na251CrO4) or 111In (approximately 10-30 μCi) as indium oxine, depending 
upon the randomization assignment and period as applicable. Subjects will be randomized with 
equal probability to the radiolabeling sequences (111In/51Cr vs. 51Cr/111In) for Test/Control.  
The isotope labels will be assigned randomly with equal probability that Control and Test 
platelets will be labeled with each isotope, and the same randomization assignment of isotope 
labels will be utilized for both apheresis collections for the same subject in Stage 1. After 
radiolabeling, the autologous Control and Test platelet samples will be simultaneously infused 
into the subject (approximately 10-30 mL). A negative pregnancy test for females of 
childbearing potential is required before infusion. 
Blood samples will be drawn immediately before infusion and for radioactivity measurements 
at 1 hour ± 15 min and 2 hours ± 15 min post-infusion (Day 0), and 6 more samples will be 
drawn at 1, 2, 3, 4 (or 5 or 6), 7 or 8, and 11±1 days post-infusion (DPI), at approximately the 
same time of day as the radiolabeled platelet infusion was administered (±4 hours). The exact 
time of each sample draw will be recorded. 
For subjects enrolled in Stage 1, there will be a minimum washout period of four weeks 
between the two study periods (e.g., four weeks after the last blood sample at 11±1 DPI, in 
Period 1). Subjects will be monitored for safety (adverse events) from the first apheresis 
procedure until 24 hours after the last DPI blood sample is drawn.  
 
Table S-1 Description of Study Stages 
 
 
Period 1 
Period 2 
 
 
Test 
Control 
Test 
Control 
Stage 
Arm 
Storage 
Duration 
(post 
collection) 
Sample 
Prep 
Sample 
Prep 
Storage 
Duration 
(post 
collection) 
Sample 
Prep 
Sample 
Prep 
Stage 1a 
Arm 1  
7 days 
Variant 1 
(n=6) 
BEST  
(n=6) 
7 days 
BEST 
(n=5) 
BEST 
(n=5) 
Arm 2  
7 days 
BEST 
(n=7) 
BEST 
(n=7) 
7 days 
Variant 1 
(n=6) 
BEST 
(n=6) 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
Name of Sponsor/Company: 
Individual Study Table  
Referring to Part  
of the Dossier 
(For National 
Authority  
 Use only) 
CERUS CORPORATION 
Name of Finished Product:   
Volume: 
 
Not applicable 
Name of Active Ingredient:  
Page:  
 
Platelets treated with the INTERCEPT 
Pathogen Reduction System Suspended in 
100% Plasma and stored for up to 7 days 
Stage 2 
Single Arm 
(n=24)b 
7 days 
Variant 1 
BEST 
Not Applicable, Single Arm 
a   Based on correspondence with FDA (BQ200481, July 8, 2020), Stage 1 was not completed. The n represents the 
number of subjects which have completed the period. 
b  Stage 1 subjects with evaluable Variant 1 method data will contribute to the requirement of the 24 subjects for Stage 2. 
Radioactivity measurements 
Samples will be obtained from the radiolabeled Control and Test platelets before infusion and 
used as a radioactive standard. The total dose of radioactivity infused will be calculated based 
on the volume of labeled platelets infused. In vitro elution of the label from the transfused 
platelets, as well as the in vivo elution of radioactivity from the serial blood samples obtained 
post-infusion will be determined by the BEST elution assessment method (Appendix B). 
The radioactivity of the samples will be determined by use of a gamma counter with correction 
for isotope spill over. Duplicate whole blood (WB) samples will be counted for each time 
point. Sample dilutions for enumeration of radioactivity of the standards will be calibrated to 
ensure that measured values are at least 10-fold above background values. The subject’s WB 
samples will be corrected for the activity in the cellular fraction determined by simple 
centrifugation and non-platelet residual activity using the 11 ±1 DPI results. Data points 
greater than 20 hours post-infusion will be used to calculate the post infusion recovery after all 
radioactive corrections have been made.  A multiple-hit model will be used to estimate the 
survival of the radioactively labeled platelets. 
At defined post infusion timepoints, a portion of the subject’s WB sample will be applied to a 
Ficoll gradient to allow for separation of the RBC/WBC fraction from the 
plasma/platelet/WBC fraction of the WB.  The radioactivity of the non-RBC and RBC 
fractions will be measured by use of a gamma counter to allow for the characterization of the 
extent of radiolabeled RBC contamination in the WB sample.  This assessment will be 
performed at 1, 4 (or 5 or 6), and 11±1 DPI during Stage 1 and at 11±1 DPI for Stage 2; the 
radioactivity will be measured alongside radioactivity measurement of the subject’s cellular 
fraction derived from centrifugation of the WB.  
 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
Name of Sponsor/Company: 
Individual Study Table  
Referring to Part  
of the Dossier 
(For National 
Authority  
 Use only) 
CERUS CORPORATION 
Name of Finished Product:   
Volume: 
 
Not applicable 
Name of Active Ingredient:  
Page:  
 
Platelets treated with the INTERCEPT 
Pathogen Reduction System Suspended in 
100% Plasma and stored for up to 7 days 
In vitro evaluation of platelets 
In vitro platelet function of the platelet component will be evaluated on Days 0/1 (pre-
treatment) and at end of storage (Day 7). In addition, platelet count, volume, and dose will be 
assessed at the end of INTERCEPT treatment on Day 1/2 to assess platelet yield retention post 
INTERCEPT treatment.  
The physical and metabolic characteristics to be evaluated at each timepoint are listed in 
Table S-2. 
Table S-2 In Vitro Platelet Function Assays to Evaluate INTERCEPT Platelet 
Components 
Assay 
Pre INTERCEPT 
Day 0-1 
Post 
INTERCEPT 
End of 
Storage 
Component weight (g) 
X 
X 
X 
Platelet count (×103/µL) 
X 
X 
X 
Platelet dose (×1011 cells/unit) a 
X 
X 
X 
Mean platelet volume (MPV) (fL) 
- 
- 
X 
Morphology score (max 400) 
- 
- 
X 
pH22°C 
X 
- 
X 
pO2 (37°C) (mm Hg)c 
- 
- 
X 
pCO2 (37°C) (mm Hg)c 
- 
- 
X 
HCO3− (37°C) (mmol/L)c 
- 
- 
X 
Supernatant glucose (mmol/L)c 
- 
- 
X 
Supernatant lactate (mmol/L)c 
- 
- 
X 
Supernatant LDH (U/L) c 
X 
- 
X 
Total LDH (U/L) 
X 
- 
X 
ATP (µmol/dL)c 
X 
- 
X 
Extent of Shape Change (%) (ESC) 
- 
- 
X 
Hypotonic Shock Response (%) (HSR) 
- 
- 
X 
CD62P (% P-selectin expression)  
X 
- 
X 
Platelet lysis (%)b 
X 
- 
X 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
Name of Sponsor/Company: 
Individual Study Table  
Referring to Part  
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(For National 
Authority  
 Use only) 
CERUS CORPORATION 
Name of Finished Product:   
Volume: 
 
Not applicable 
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Page:  
 
Platelets treated with the INTERCEPT 
Pathogen Reduction System Suspended in 
100% Plasma and stored for up to 7 days 
Bacterial culture 
- 
1 - 3 days 
before end of 
storage 
- 
a 
Platelet dose is calculated from the platelet count and volume. 
b 
Calculated from ratio of LDH activity in 1 mL of platelet concentrate supernatant to the total 
LDH activity in 1 mL of Triton X-100 lysed platelet concentrate. 
c 
The values for these parameters will also be normalized for platelet count. 
Number of subjects: 
Up to a total of 36 subjects with evaluable (Test and Control) recovery and survival data may 
be obtained.  Randomized subjects who do not have both paired (Test and Control) recovery 
and paired survival data for a given stage or who are unable to provide a second matched 
donation for Stage 1 will be replaced, unless the enrollment goal is met. Up to 45 subjects may 
be required to obtain a sufficient number of evaluable subjects. 
Main criteria for inclusion:  
Inclusion criteria: 
• 
Age ≥18 years, of either gender. 
• 
Normal health status (as determined by the Investigator review of medical history and blood donor 
physical exam). 
• 
Meet FDA, AABB, and site guidelines for blood donation and apheresis platelet donation. Travel, 
tattoos/piercings and/or male to male sexual contact deferrals do not apply. 
• 
Complete blood count (CBC) and serum chemistry values within established reference ranges or 
within guidelines as above. 
• 
Pre-donation platelet count of more than 150×109 platelets/ L. 
• 
Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, syphilis, and WNV. 
• 
Subjects of childbearing potential must agree to use a medically acceptable method of 
contraception throughout the study. A barrier method of contraception must be included, regardless 
of other methods. 
• 
Signed and dated informed consent form. 
Exclusion criteria: 
• 
For participation in Stage 2, received any previous infusion in this study. 
• 
Clinically significant acute or chronic disease (as determined by the Investigator). 
• 
Pregnant or nursing females. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
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Authority  
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Name of Finished Product:   
Volume: 
 
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Page:  
 
Platelets treated with the INTERCEPT 
Pathogen Reduction System Suspended in 
100% Plasma and stored for up to 7 days 
• 
Subjects of childbearing potential not using effective contraception. 
• 
Disease states or conditions that preclude apheresis platelet donation per AABB reference 
standards. 
• 
Treatment with aspirin or aspirin-containing medications within 7 days of apheresis or treatment 
with non-steroidal anti-inflammatory drugs (NSAID), anti-platelet agents (or other drugs affecting 
platelet viability within 3 days of apheresis (e.g., ibuprofen or other NSAIDs). 
• 
Subject received platelet inhibitors within 14 days of donation (e.g., clopidogrel, ticlopidine, 
amphetamines (e.g., Adderall, Dexedrine)). 
• 
Subjects with positive cocaine and/or amphetamine results from urine drug screen.  
• 
Splenectomized subjects. 
• 
History of known hypersensitivity to indium or chromium. 
• 
Has received an investigational drug within the past 28 days. 
Test product and mode of administration:  
Apheresis platelet components in 100% plasma collected using the Trima separator, prepared 
with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7days at 20-
24°C with continuous agitation.  Samples from the Test component will be processed with 
either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous 
Test and Control platelets (approximately 10-30 mL) will be simultaneously administered 
intravenously into the subject.   
Duration of treatment: 
Within 15 days prior to participating in any study stage, subjects will be screened for 
eligibility. For each enrolled subject, study participation will include 17-19 days following 
each apheresis platelet procedure depending on day of the last blood sample, with an initial 
screening window of up to 15 days, or approximately 77-81 days (including wash out period) 
for a Stage 1 or approximately 32-34 days for Stage 2.   

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
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Authority  
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Name of Finished Product:   
Volume: 
 
Not applicable 
Name of Active Ingredient:  
Page:  
 
Platelets treated with the INTERCEPT 
Pathogen Reduction System Suspended in 
100% Plasma and stored for up to 7 days 
Reference therapy and mode of administration:  
Autologous fresh, whole derived platelets isolated from platelet rich plasma (Control platelets) 
processed and radiolabeled using the BEST protocol will be administered simultaneously with 
the radiolabeled Test platelets into the subject. 
 
Criteria for evaluation: 
Efficacy: 
Primary endpoints 
The primary efficacy endpoints for Stage 1 and Stage 2: 
• 
Post-infusion recovery at end of storage  
• 
Post-infusion survival at end of storage 
Using the FDA standard on platelet viability by radiolabeling (i.e., recovery and survival 
compared to a “fresh” autologous platelet sample as control, drawn and prepared on day of 
reinfusion of radiolabeled test samples), the acceptance criteria are:  
• 
Lower bound of a two-sided 95% confidence interval (CI) for the mean treatment 
difference (Test-0.66×Control) in post-infusion recovery is greater than or equal to 
zero. 
• 
Lower bound of a two-sided 95% CI for the mean treatment difference 
(Test-0.58×Control) in survival is greater than or equal to zero. 
For Stage 1, the above criteria for recovery and survival of INTERCEPT components will be 
evaluated separately for INTERCEPT platelets (Test) labeled with the BEST and Variant 1 
procedures. 
Secondary endpoints (product parameter evaluation of platelet components) 
For each stage, the secondary efficacy endpoints will be summarized descriptively and are 
based on product parameters post-INTERCEPT treatment and at end of storage.  
Product Parameters at the end of INTERCEPT Treatment 
• 
Platelet count, volume, and dose (≥3.0×1011)  
• 
Platelet yield retention (≥80%) 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
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Authority  
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Volume: 
 
Not applicable 
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Platelets treated with the INTERCEPT 
Pathogen Reduction System Suspended in 
100% Plasma and stored for up to 7 days 
Product Parameters at the end of storage 
• 
pH 22°C (≥6.2) 
Additional endpoints 
Additional analyses will include the in vitro function parameters of the stored INTERCEPT 
platelet component (before radiolabeling preparation process) and the platelet samples (after 
radiolabeling preparation process) prior to radiolabeling. 
Assessments of the stored INTERCEPT platelet components (end of Day 7) 
Product Parameters 
Biochemical  
Functional  
• 
component 
volume 
• 
glucose & normalized 
consumption per 
platelet count 
• 
hypotonic shock 
response (HSR) 
• 
platelet count 
• 
Lactate & normalized 
production per platelet 
count 
• 
extent of shape 
change (ESC) 
• 
platelet dose 
• 
pO2 & normalized 
consumption per 
platelet count 
• 
CD62P (p-selectin) 
expression 
 
• 
pCO2 & normalized 
production per platelet 
count 
• 
morphology score  
 
• 
bicarbonate 
• 
mean platelet 
volume 
 
• 
lactate dehydrogenase 
normalized per platelet 
count 
 
 
• 
ATP & normalized per 
platelet count 
 
 
• 
Lysis and % of baseline 
adjusted lysis 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
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of the Dossier 
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Authority  
 Use only) 
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Name of Finished Product:   
Volume: 
 
Not applicable 
Name of Active Ingredient:  
Page:  
 
Platelets treated with the INTERCEPT 
Pathogen Reduction System Suspended in 
100% Plasma and stored for up to 7 days 
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling 
For Stage 1, the in vitro platelet processing recovery (≥ 80%), pH 22°C (≥ 6.2), volume, platelet 
count and CD62P, as well as RBC and WBC contamination, will be summarized descriptively 
for Test samples processed using both the BEST and Variant 1 procedures.  
During Stage 2 the in vitro platelet recovery (≥ 80%), pH 22°C (≥ 6.2), volume and platelet 
count will be summarized descriptively for Test samples processed using the Variant 1 
procedure.  
 
Safety 
Subjects' vital signs, hematology and chemistry evaluations, and treatment-emergent adverse 
events (AE) will be collected from the initiation of apheresis collection through 24 hours after 
the last DPI blood sample is drawn.   
Analysis sets: 
Safety Analysis Set: 
All randomized subjects who successfully initiate an apheresis collection. 
 
Evaluable Analysis Set (EAS): 
All randomized and infused subjects who have both paired (Test and Control) recovery and 
paired survival data for the relevant study stage and/or radiolabeling method, and otherwise 
complied with the protocol without any other major protocol deviation.   
Summaries for the efficacy endpoints will be presented using EAS. All other summaries will 
be presented using the safety analysis set unless stated otherwise. 
Statistical methods: 
Data will be summarized descriptively by mean, standard deviation, median, and range 
(minimum, maximum) for continuous parameters, and by frequencies and percentages for 
categorical data variables. Summaries will be presented by radiolabeling method across all 
study sites and within each study site. 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
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CERUS CORPORATION 
Name of Finished Product:   
Volume: 
 
Not applicable 
Name of Active Ingredient:  
Page:  
 
Platelets treated with the INTERCEPT 
Pathogen Reduction System Suspended in 
100% Plasma and stored for up to 7 days 
Primary endpoints 
Stage 1’s recovery and survival data with 7-day platelet storage will be assessed separately by 
the pre-radiolabeling platelet sample preparation (BEST or Variant 1) and compared with its 
paired control descriptively.   
For Stage 2, the following acceptance criteria for recovery and survival will be used to 
demonstrate non-inferiority of Test (stored INTERCEPT treated) platelets against Control 
(fresh) platelets: 
(1) For post-infusion recovery: 
 
H0: Test - 0.66×Control <0 vs. H1: Test - 0.66×Control ≥0 
The null hypothesis will be rejected if the lower bound of a two-sided 95% CI for the mean 
treatment difference (Test - 0.66×Control) is greater than or equal to zero. 
(2) For survival: 
 
H0: Test - 0.58×Control <0 vs. H1: Test - 0.58×Control ≥0 
The null hypothesis will be rejected if the lower bound a two-sided 95% CI for the mean 
treatment difference (Test - 0.58×Control) is greater than or equal to zero. 
The primary analysis population for the primary efficacy endpoints will only include subjects 
who have both paired (Test and Control) recovery and paired survival data for the relevant 
study stage and/or radiolabeling method.  The two-sided CIs will be computed using the 
variance estimated from a paired t test. 
In the event that non-inferiority cannot be declared for the primary endpoints for Stage 2 with a 
minimum of 24 evaluable subjects, additional exploratory analyses may be conducted to 
quantify the proportions of subjects whose recovery and survival data meet the 0.66 and 0.58 
cutoff, respectively (e.g., platelet recovery from a Test platelet component greater than or equal 
to 66% of platelet recovery from the paired fresh control platelets). 
Secondary endpoints 
Data will be summarized descriptively for each stage.  The proportions of Test platelet 
components with platelet dose ≥3.0 ×1011 (end of INTERCEPT treatment), physical platelet 
recovery ≥80% (end of INTERCEPT treatment), and pH22°C ≥6.2 (end of storage) will be 
summarized, with the corresponding lower bound of a one-sided 95% CI for the proportion 
provided. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
Name of Sponsor/Company: 
Individual Study Table  
Referring to Part  
of the Dossier 
(For National 
Authority  
 Use only) 
CERUS CORPORATION 
Name of Finished Product:   
Volume: 
 
Not applicable 
Name of Active Ingredient:  
Page:  
 
Platelets treated with the INTERCEPT 
Pathogen Reduction System Suspended in 
100% Plasma and stored for up to 7 days 
Correlations between the primary and secondary efficacy endpoints may also be explored 
using graphs and/or regression analysis.  
Additional endpoints 
Evaluation of the BEST (Stage 1) and Variant 1 (Stages 1 and 2) procedures for processing 
Test platelet samples prior to radiolabeling will also include the following assessment criteria:  
• In vitro physical platelet recovery ≥ 80% 
• pH 22°C ≥ 6.2  
The proportions of processed samples meeting each of the above assessment criteria will be 
summarized separately for the BEST and Variant 1 procedures as applicable.   
Additionally, RBC and WBC contamination in Test samples prior to radiolabeling (Stage 1), 
the proportion of radioactivity (Test and Control) associated with the Ficoll RBC fraction 
gradient and treatment-emergent AEs (defined as AEs with onset after the initiation of 
apheresis collection) will be summarized descriptively. 
 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
TABLE OF CONTENTS 
1.0 
SYNOPSIS ......................................................................................................................2 
2.0 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ...........................17 
3.0 
BACKGROUND INFORMATION ............................................................................20 
3.1 
Name and Description of the Investigational Product ........................................22 
3.2 
Summary of Nonclinical and Clinical Studies ....................................................24 
3.2.1 In Vivo Assessments of Stored INTERCEPT Platelets .............................24 
3.3 
Summary of Potential Risks and Benefits ..........................................................29 
3.3.1 Benefits of Study Participation ..................................................................29 
3.3.2 Risks of Study Participation.......................................................................29 
4.0 
TRIAL OBJECTIVE ...................................................................................................32 
5.0 
TRIAL DESIGN ...........................................................................................................33 
5.1 
Overall Trial Design and Plan.............................................................................33 
5.2 
Randomization and Blinding ..............................................................................35 
5.3 
Treatment and Dose ............................................................................................36 
5.3.1 Administration of Study Product ...............................................................36 
5.3.2 Preparation of the Study Test Platelet Component ....................................36 
5.3.3 Duration of Subject Participation...............................................................41 
5.3.4 Schedule of Assessments and Procedures..................................................43 
5.3.5 Subject Screening.......................................................................................46 
 Platelet Apheresis Collection and Storage .................................................47 
5.3.7 Bacterial Testing ........................................................................................48 
5.3.8 Platelet Storage: Stage 1 Days 1-7; Stage 2 Days 1-7 ...............................48 
5.3.9 Platelet Radiolabeling and Infusion, Day 7 (0 DPI) ..................................48 
5.3.10 Subject Procedures: 1 – 7 DPI ...................................................................51 
5.3.11 Subject Procedures – End of Study ............................................................51 
5.3.12 Study Procedure Definitions ......................................................................52 
5.4 
Accountability of Investigational Product ..........................................................55 
5.4.1 Handling and Disposal ...............................................................................55 
6.0 
SELECTION AND WITHDRAWAL OF SUBJECTS .............................................56 
6.1 
Subject Inclusion Criteria ...................................................................................56 
6.2 
Subject Exclusion Criteria ..................................................................................56 
6.3 
Subject Withdrawal Criteria ...............................................................................57 
6.4 
Stopping Rules ....................................................................................................58 
7.0 
TREATMENT OF SUBJECTS ..................................................................................59 
7.1 
Treatments...........................................................................................................59 
7.1.1 Subject Confinement and Restrictions .......................................................60 
7.2 
Concomitant and Excluded Therapy ...................................................................60 
7.3 
Subject Compliance ............................................................................................60 
8.0 
ASSESSMENT OF EFFICACY .................................................................................61 
8.1 
Efficacy Parameters ............................................................................................61 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
8.1.1 Primary Efficacy Endpoints .......................................................................61 
8.1.2 Secondary Efficacy Endpoints ...................................................................61 
8.1.3 Additional Endpoints .................................................................................61 
8.2 
Methods and Timing of Efficacy Parameters .....................................................62 
8.2.1 Assessment of Stored Platelet Samples Prior to Radiolabeling .................62 
8.2.2 Radioactivity Measurements and Recovery and Survival Estimation .......63 
8.2.3 Red Blood Cell Contamination Assessment ..............................................64 
8.2.4 In Vitro Platelet Assessments ....................................................................64 
9.0 
ASSESSMENT OF SAFETY ......................................................................................66 
9.1 
Safety Parameters................................................................................................66 
9.1.1 Safety Endpoints ........................................................................................66 
9.2 
Methods and Timing of Safety Parameters .........................................................66 
9.3 
Recording and Reporting Adverse Events ..........................................................66 
9.3.1 Definition of Adverse Event ......................................................................66 
9.3.2 Definition of Serious Adverse Event .........................................................67 
9.3.3 Definition of Unanticipated Adverse Device Effects ................................67 
9.3.4 Assessing Relationship of the Adverse Event to the Study Procedure ......67 
9.3.5 Assessing Severity of Adverse Event ........................................................68 
9.3.6 Assessing Seriousness of an Adverse Event ..............................................69 
9.3.7 Reporting Adverse Events .........................................................................69 
9.4 
Adverse Event Follow up....................................................................................69 
10.0 STATISTICS ................................................................................................................70 
10.1 
Analysis Sets .......................................................................................................70 
10.2 
Statistical Methods ..............................................................................................70 
10.2.1 Efficacy Analyses ......................................................................................71 
10.2.2 Additional Endpoints .................................................................................72 
10.2.3 Safety Analyses ..........................................................................................72 
10.3 
Determination of Sample Size ............................................................................72 
10.4 
Level of Significance ..........................................................................................73 
10.5 
Criteria for Termination of the Study .................................................................73 
10.6 
Procedure for Missing, Unused, and Spurious Data ...........................................73 
10.7 
Deviations from the Statistical Plan ....................................................................73 
10.8 
Selection of Subjects to be Analyzed..................................................................73 
11.0 DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ........................................74 
12.0 QUALITY CONTROL AND QUALITY ASSURANCE .........................................75 
13.0 ETHICS .........................................................................................................................76 
13.1 
Ethical Conduct of the Study ..............................................................................76 
13.2 
Informed Consent................................................................................................76 
13.3 
Institutional Review Board (IRB) .......................................................................76 
13.4 
Participant Recruitment ......................................................................................77 
13.5 
Disclosure of data ...............................................................................................77 
14.0 DATA HANDLING AND RECORD KEEPING ......................................................78 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
15.0 PUBLICATION POLICY ...........................................................................................79 
16.0 APPENDICES ..............................................................................................................80 
 
Literature References .....................................................................81 
 
BEST version 4.2.1 Radiolabeling Procedure ...............................85 
 
Radiolabeling Procedure for Platelets (Variant 1) .......................103 
 
LIST OF TABLES 
Table 1 
Differences between the BEST 4.2.1 Radiolabeling Method and Variant 1 for 
Preparation of Stored Apheresis Platelet Sample$ .................................................22 
Table 2 
Components of the INTERCEPT Platelet Processing Sets....................................23 
Table 3 
Recovery and Lifespan of Radiolabeled Autologous INTERCEPT Platelets 
Stored for 7-days Compared to Fresh Controls (Study CLI 00099) ......................25 
Table 4 
Comparison of Platelet, RBC and WBC Count in Platelet Samples Prepared 
for Radiolabeling Using the BEST (WB Derived Fresh Platelets and 
INTERCEPT Stored Platelets) and Variant 1 Method (INTERCEPT Stored 
Platelets) (Study REL 00556) ................................................................................28 
Table 5 
Description of Study Stages ...................................................................................34 
Table 6 
Study Schema.........................................................................................................42 
Table 7 
Study Assessments .................................................................................................43 
Table 8 
Release Criteria on Day of Radiolabeling/Infusion ...............................................49 
Table 9 
Subject Clinical Laboratory Tests ..........................................................................54 
Table 10 Assessment of Test Platelet Sample Prior to Radiolabeling ..................................63 
Table 11 In Vitro Platelet Function Assays to Evaluate INTERCEPT Platelet 
Components ...........................................................................................................64 
Table 12 Causality Assessment Scale ...................................................................................68 
Table 13 Severity Grading Scale ..........................................................................................68 
Table 14 Sponsor Contact Information .................................................................................69 
Table 15 BEST Version 4.2.1 Modifications ......................................................................100 
Table 16 Variant 1 of BEST Version 4.2.1 Method Modifications ....................................118 
 
LIST OF FIGURES 
 
INTERCEPT Blood System for Platelets ..............................................................24 
 
Flow Diagram of the INTERCEPT Process for Platelets ......................................39 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
2.0 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS  
AABB 
Formerly known as the American Association of Blood 
Banks 
ACD-A  
Anticoagulant Citrate Dextrose Solution-Formula A, USP 
(2.13% free citrate ion)  
ADE 
Adverse Device Effect. There is a causal relationship 
between the device and an adverse event. 
AE 
Adverse Event (defined in Section 9.3.1) 
ALI 
Acute Lung Injury 
ARDS 
Acute Respiratory Distress Syndrome 
ATP 
Adenosine 5’-Triphosphate 
AUC 
Area Under the Curve 
BEST 
Biomedical Excellence for Safer Transfusion 
BMI 
Body Mass Index 
CAD 
Compound Adsorption Device 
CBC 
Complete Blood Count 
CCI 
Corrected Count Increment 
CD62 
P-selectin expression 
51Chromium 
An isotope of chromium with a radioactive half-life of  
27.7 days 
CI 
Count Increment 
CRF 
Case Report Form 
Control 
Fresh autologous platelets 
D 
Days  
Device Malfunction 
The failure of a medical device to function according to its 
requirements.   
DPI 
Days post infusion of autologous radiolabeled platelets  
DS 
Dual Storage (two storage containers) 
DH 
Dartmouth-Hitchcock Medical Center 
EDTA 
Ethylenediaminetetraacetic acid 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
ESC 
Extent of Shape Change 
FDA 
US Food and Drug Administration 
GCP  
Good Clinical Practice 
H 
Hour 
HBC 
Hoxworth Blood Center 
HBV 
Hepatitis B virus 
HCV 
Hepatitis C virus 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
Human Immunodeficiency Virus 
HPLC 
High-Performance Liquid Chromatography 
HSR 
Hypotonic Shock Response 
HTLV 
Human T-Lymphotropic Virus 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization of Technical 
Requirements for Registration of Pharmaceuticals for 
Human Use 
111Indium 
An isotope of indium with a radioactive half-life of 2.80 
days 
INTERCEPT 
Platelet or Platelet 
Component 
Apheresis platelets suspended in in 100% plasma and 
treated with the INTERCEPT Blood System for Platelets  
 
INTERCEPT Blood 
System® for Platelets 
A medical device that inactivates infectious pathogens 
(viruses, bacteria, and protozoa) and leukocytes using 
amotosalen and UVA light in platelet components. 
IRB 
Institutional Review Board 
LDH 
Lactate dehydrogenase 
Min 
Minute 
MPV 
Mean Platelet Volume 
mrem 
Millirem 
mSv 
Millisievert 
NSAID 
Non-steroidal anti-inflammatory drug 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
PAS 
Platelet additive solution 
PC 
Platelet Component 
PHI 
Protected Health Information 
PRP 
Platelet-Rich Plasma 
QA 
Quality Assurance 
RBC 
Red Blood Cell 
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure 
Sponsor  
Cerus Corporation 
SV 
Small volume 
TACO 
Transfusion-Associated Circulatory Overload 
TAD 
Transfusion-Associated Dyspnea 
TA-GVHD 
Transfusion-Associated Graft Versus Host Disease 
Test 
Apheresis platelets suspended in in 100% plasma and 
treated with the INTERCEPT Blood System for Platelets  
TRALI 
Transfusion-Related Acute Lung Injury 
TTI 
Transfusion-Transmitted Infection 
UADE 
Unanticipated Adverse Device Effect 
UVA 
Ultraviolet A light  
WB 
Whole blood 
WBC 
White Blood Cell 
WNV 
West Nile Virus 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
3.0 
BACKGROUND INFORMATION 
The INTERCEPT Blood System for Platelets is intended to be used for ex vivo preparation of 
pathogen-reduced apheresis platelet components (PCs) in order to reduce the risk of 
transfusion-transmitted infection (TTI), including sepsis, and as an alternate to gamma 
irradiation for prevention of transfusion-associated graft-versus-host disease (TA-GVHD). 
The INTERCEPT Blood System for Platelets is a Class III medical device consisting of plastic 
disposable sets and an illumination device (INTERCEPT Illuminator), which provides a 
controlled dose of ultraviolet A (UVA) light to the PC. The final product is either transfused or 
stored according to blood center standard operating procedures (SOP), US Food and Drug 
Administration (FDA), and American Association of Blood Banks (AABB) Guidelines.  
The INTERCEPT Blood System for Platelets was approved by the FDA in December 2014 for 
treatment of platelets collected in a commercially available platelet additive solution.  In 
March 2016, the FDA approved the use of the INTERCEPT System for treatment of platelets 
suspended in 100% plasma.  As part of the approval, Cerus committed to a post-approval study 
to evaluate the recovery and survival of apheresis platelets suspended in 100% plasma and 
treated with the INTERCEPT Blood System for Platelets. Cerus also received approval for 
INTERCEPT Processing Sets manufactured with alternate plastics and design changes and the 
INT100G2 Illuminator in May 2018. 
The current maximal expiration dating period for INTERCEPT platelets in the U.S. is 5 days. 
Prior limitations to storing platelets beyond 5 days have been due to increased risk of bacterial 
proliferation associated with initial contamination of the platelet components and subsequent 
increased risk of transfusion related sepsis (Kleinman, et al. 2013). These limitations may be 
resolved by the INTERCEPT pathogen reduction technology to reduce the risk of transfusion 
related sepsis. Extension of apheresis platelet component expiration dating to 6 or 7 days after 
collection would increase the availability and reduce the wastage of PCs. The feasibility for 
extension of storage of INTERCEPT platelets for up to 7 days without increasing the risk of 
bacterial contamination and transfusion-related sepsis is supported by studies demonstrating 
effective inactivation of bacteria generally >4 log10 with negative cultures at outdate 
(Schmidt 2015, Wagner 2016), in vitro platelet function studies (CLI 00123 and CLI 00124) 
and an in vivo recovery and survival pilot study (CLI 00099) of apheresis-derived PCs 
suspended in either 100% plasma or platelet additive solution (35% plasma/ 65% PAS-3). The 
therapeutic efficacy of INTERCEPT PCs stored for 7 days is supported by a Phase 3 study 
(Lozano, et al. 2011) and post-marketing experience obtained in several European countries 
where the INTERCEPT Blood System for Platelets is licensed for 7 days of storage. Four 
years of safety data from Switzerland with INTERCEPT platelets stored up to 7 days have 
demonstrated no cases of definite transfusion related sepsis (Amsler and Jutzi, Swissmedic 
Haemovigilance Annual Report 2014). Routine experience in Innsbruck, Austria showed no 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
increase in platelet usage when implementing INTERCEPT platelets stored for up to 7 days, 
and no effect in clinical outcomes in massively transfused patients (Amato 2016, Nussbaumer 
2017). Cumulatively, this body of evidence warrants the in vivo characterization of recovery 
and survival of INTERCEPT PCs stored for up to 7 days.   
This study will compare the in vivo post-infusion radiolabeled recovery and survival of 
INTERCEPT platelets (Test) suspended in 100% plasma and stored for up to 7 days to fresh 
autologous platelets (Control) prepared from platelet rich plasma (PRP) isolated from whole 
blood. The results of this study are intended to support an extended shelf-life claim beyond 5 
days of storage for INTERCEPT platelets suspended in either 100% plasma or 35% plasma/ 
65% PAS-3 using the currently approved INTERCEPT platelet processing sets (Small 
Volume, SV, Large Volume, LV or Dual Storage, DS). 
Although radiolabeling studies have been performed with stored apheresis platelets in additive 
solutions (Vassallo 2010 and Dumont 2013) and apheresis platelets in 100% plasma 
(Dumont 2002 and Vassallo 2004), quality control of the platelet samples processed for 
radiolabeling has not been performed.  Cerus has evaluated variations of the Biomedical 
Excellence for Safer Transfusion Collaboration (BEST) platelet handling methods prior to 
radiolabeling to optimize platelet recovery and improve platelet quality (VAL 00376 and 
REL 00556).  These studies have shown that the platelet preparation procedure described in 
the BEST version 4.2.1 protocol may not be optimal for preparing stored apheresis platelets 
for radiolabeling (Steps 4.2 and 5.2 of the BEST Platelet Radiolabeling Procedure 
Version 4.2.1, Appendix B).  The first two steps in preparing stored platelet samples for 
radiolabeling involve anticoagulation and acidification of the sample, using ACD-A, and a soft 
spin to separate and remove contaminating RBCs and WBCs (Table 1). These steps are not 
necessary for stored apheresis platelets since the platelet components are collected in ACD-A 
and have low RBC and WBC contamination due to the apheresis collection procedures.  
Furthermore, the first two steps of the platelet preparation steps have been shown to decrease 
physical platelet recovery and negatively impact platelet quality (described further in 
Section 3.2.1.3).  The Variant 1 of BEST method (referred to as Variant 1, Appendix C) does 
not include the first two steps of the platelet preparation steps (Table 1).   
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
Table 1 
Differences between the BEST 4.2.1 Radiolabeling Method and Variant 1 for 
Preparation of Stored Apheresis Platelet Sample$ 
BEST 4.2.1 Method 
Variant 1 Method* 
Anticoagulant added to the 
platelet sample 
ACD-A 
(15%, pH 4.5 - 5.5) 
None 
Soft Spin 
200g, 5 minutes, 
harvest  
Platelet Rich Plasma 
Not done 
Hard Spin 
Platelet Rich Plasma 
(PRP) 1500-2000g, 
15 minutes 
Platelet Sample 
1500-2000g, 
15 minutes 
Resuspension of platelet pellet 
ACD-A/Saline  
(pH 6.5 - 6.8) 
ACD-A/Saline  
(pH 6.5 - 6.8) 
*As described by Snyder, et al 1986. 
$ Control autologous whole blood platelets are prepared using the BEST 4.2.1 method in both arms of both study 
Stages. 
 
An additional objective of this study is to compare the recovery and survival results for 
INTERCEPT platelets (Test) prepared for radiolabeling using the procedures outlined by 
BEST or Variant 1. This comparison will test the hypothesis that optimizing platelet recovery 
and retaining platelet in vitro quality while preparing samples from platelet components for 
radiolabeling will influence the outcome of post-infusion recovery. 
3.1 
Name and Description of the Investigational Product 
The INTERCEPT Blood System for Platelets is a medical device (Table 2, Figure 1) 
consisting of a single-use processing set (INTERCEPT Processing Set for platelets) and an 
illumination device (INTERCEPT Illuminator), which provides a controlled dose of ultraviolet 
A (UVA) light to the platelet component(s). The apheresis-derived platelet component (PC), 
prepared with the INTERCEPT Blood System for Platelets, is an investigational biological 
product in this study (INTERCEPT platelet component). The radiolabeled Control platelets are 
also considered investigational. 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
Table 2 
Components of the INTERCEPT Platelet Processing Sets 
Component 
Description 
Amotosalen (S-59, psoralen 
derivative) solution container 
Platelet SV Processing Set (INT2130B): 15 mL, 3 mM 
amotosalen in 0.924% NaCl packaged in a 20 mL, flexible, heat-
sealed plastic container, with light protective sleeve  
Platelet LV and DS Processing Sets (INT2230B and INT 
2530B): 17.5 mL, 3 mM amotosalen in 0.924% NaCl packaged 
in a 20 mL, flexible, heat-sealed plastic container, with light 
protective sleeve 
Illumination container 
Heat-sealed, plastic bag 
Compound Adsorption Device 
(CAD) 
Immobilized beads (wafer) in mesh pouch 
CAD container 
Platelet SV and LV Processing Sets (INT2130B and INT2230B): 
1000 mL capacity  
Platelet DS Processing Set (INT 2530B): 1300 mL capacity 
Platelet storage containers 
Platelet SV and LV Processing Sets (INT2130B and INT2230B): 
One platelet storage bag – 1300 mL storage capacity 
Platelet DS Processing Set (INT 2530B): Two platelet storage 
bags – 1300 mL storage capacity each 
 
The Dual Storage processing set (INT25) that will be used in this study is currently approved 
and consists of the following sequentially integrated components: 17.5 mL of 3 mM 
amotosalen solution, a 1 liter Renolit Transfufol 8300 illumination container, a 1.3 liter 
Renolit Transfufol 8300 container with compound adsorption device (CAD, Renolit Transfufol 
8300 binder material), an in-line filter, and two 1.3 liter Transfufol 8300 storage containers.  
The INTERCEPT Illuminator is capable of illuminating two platelet illumination containers 
per processing period. Each PC rests on a UVA-transparent tray and undergoes reciprocal 
shaking during illumination. The INTERCEPT Illuminator delivers a target dose of 
3.9 Joules/cm2 (J/cm2) UVA treatment to each PC through a pair of opposing banks of 
fluorescent lamps.  The INT100 G2 INTERCEPT Illuminator will be used for this study. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
CLI 00127, v5.0  
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disclosure without express written consent from Cerus Corporation. 
 
INTERCEPT Blood System for Platelets 
 
3.2 
Summary of Nonclinical and Clinical Studies 
The nonclinical and clinical studies are summarized in the Package Insert 
(SPC 00701-AW v3.0 INTERCEPT Blood System for Platelets – Dual Storage (DS) 
Processing Set). The following paragraphs provide additional background for the proposed 
study. 
3.2.1 In Vivo Assessments of Stored INTERCEPT Platelets  
Extension of platelet storage for up to 7 days for INTERCEPT platelets has been explored in 
in vitro studies (CLI 00094, CLI 00095, CLI 00123 and CLI 00124). The results from these 
studies show that the in vitro quality of INTERCEPT platelets stored in 65% PAS-3/35% 
plasma or 100% plasma is adequate when compared to untreated platelets and similar to the 
results published for conventional Amicus platelets stored in InterSol (Vassallo 2010) and 
Trima platelets in 100% plasma stored for 5 days (Dumont 2013).  
In addition, Cerus has conducted an in vivo pilot recovery and survival study (CLI 00099) for 
INTERCEPT PCs suspended in platelet additive solution (35% plasma/65% PAS-3) and 100% 
plasma stored for 7 days and a study of recovery and survival of INTERCEPT platelets in 35% 
plasma/65% PAS-3 stored for either 6 or 7 days (CLI 00116). 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
3.2.1.1 Recovery and Lifespan of Radiolabeled Autologous INTERCEPT 7-day Stored 
Apheresis Platelet Components (CLI 00099) 
A pilot study (CLI 00099) assessed the post-infusion recovery and lifespan (also referred to as 
survival) of 7-day INTERCEPT PCs stored in either 35% plasma/65% PAS-3 or 100% 
plasma, as compared to “fresh” radiolabeled platelets. Preliminary results provided evidence of 
the feasibility for INTERCEPT platelets to be stored for up to 7 days, while maintaining 
adequate transfusion viability, regardless of the suspension media.  
Mean radiolabel 24-h recovery ratios (Test/Control [“fresh” autologous platelets]) of 
INTERCEPT apheresis-derived PCs suspended in 35% plasma and 65% PAS-3 and stored for 
7 days was 65.3% and for INTERCEPT platelets in 100% plasma was 70.9%. Mean lifespan 
ratio (Test/Control) was 57.5% for INTERCEPT PCs suspended in 35% plasma and 65% 
PAS-3 and for INTERCEPT PCs in 100% plasma was 61.0% (Table 3). Although, the small 
sample sizes and wide standard deviations limit the conclusions that can be derived from this 
pilot study, the results suggest 7-day storage of INTERCEPT platelets is feasible. 
Table 3 
Recovery and Lifespan of Radiolabeled Autologous INTERCEPT Platelets 
Stored for 7-days Compared to Fresh Controls (Study CLI 00099) 
 
Apheresis PCs in 35% Plasma and 
65% PAS-3* 
Apheresis PCs in 100% Plasma* 
 
Mean (SD) 24-h 
Recovery (%) 
Mean (SD) 
Lifespan (h) 
Mean (SD) 24-h 
Recovery (%) 
Mean (SD) 
Lifespan (h) 
Control (fresh, n = 6) 
53.4 (8.9) 
214.2 (32.3) 
60.5 (16.7) 
198.6 (25.3) 
Test (IBS, n = 6)  
35.0 (8.3) 
119.6 (27.1) 
40.6 (11.6) 
120.6 (30.9) 
Ratio T:C (%) 
65.3 (8.8) 
57.5 (16.3) 
70.9 (26.2) 
61.0 (15.7) 
* ACD-A/Saline was used in the first step of the BEST sample preparation steps (Steps 4.2 and 5.2, Appendix B) 
3.2.1.2 Recovery and Lifespan of Radiolabeled Autologous INTERCEPT 6 and 7-day 
Stored Apheresis Platelet Components (CLI 00116) 
CLI 00116, a randomized, cross-over analysis of platelet recovery and survival after 
autologous transfusion of 6-day and 7-day stored INTERCEPT treated Amicus platelets in 
PAS-3 (InterSol), was conducted at both HBC and Dartmouth Hitchcock (DH). While 
conducting CLI 00099 and CLI 00116 studies, modifications to BEST version 4.2.1 were 
implemented at HBC to improve platelet yield in response to low recovery after processing 
platelet samples for radiolabeling; whereas, BEST version 4.2.1 was followed at DH for 
CLI 00116. The modifications implemented at HBC involved combining the pellets from both 
the soft and hard spins due to observations of platelet loss during the soft spin of the platelet 
sample in ACD-A. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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In study CLI 00116, the DH Investigator noted that 4 of 15 recovery assessments for Control 
(fresh) WB platelets demonstrated recoveries of >100% (101.5; 106.8%; 113.1% and 193.5%); 
the results were highly variable and not aligned with historical data (Dumont 2013; Vassallo 
2010) (communication from Dr. Dumont dated 4/11/2017). In addition, initial data from HBC 
in CLI 00116 was reported by the Investigator to show diminished performance with respect to 
the in vivo recovery/survival outcomes compared to CLI 00099.  
At DH it was noted also that radioactivity of the standards was not sufficiently high above 
background radioactivity to provide reliable measurement of specific activity. This problem 
may have been responsible for the unusual results showing radioactivity recoveries of > 100% 
in 4 subjects. A modification in the preparation of the standard samples for gamma counting 
was instituted in CLI 00116 by using decreased dilution before counting. This resulted in a 50 
to 100-fold increase in the corrected radioactivity counts for the standards above background 
and provided good precision. These DH studies demonstrated the need to implement controls 
to ensure adequate signal-to-noise ratios when measuring the radioactivity associated with the 
standards as described in this protocol.  
CLI 00116 was terminated for futility caused by poor platelet recovery yields after 
radiolabeling.  
3.2.1.3 Method optimization of preparation of stored platelets for radiolabeling 
A small investigational study was performed to assess the radiolabeling methodologies used at 
HBC during CLI 00116.  The results of this study indicated that the addition of acidic 
(pH 4.5 - 5.5), undiluted ACD-A to stored apheresis platelets before the first soft spin per the 
BEST protocol (designed to remove residual RBC and WBC from PRP derived from fresh 
blood) resulted in poor platelet recovery yield and inferior in vitro platelet quality of the 
aliquots compared with platelets resuspended in diluted, pH adjusted (pH 6.5-6.8) 
ACD-A/saline. Together with the recovery and survival results from CLI 00099, these data 
indicated that injury may be induced by the addition of a high [H+]-containing solution 
(ACD-A) when added to stored apheresis PCs.  
Based on the investigational study results, a prospective in vitro study (VAL 00376) was 
designed and completed to assess two alternative platelet preparation methods based on the 
BEST version 4.2.1 protocol for preparation of stored platelet samples for radiolabeling using 
both untreated and INTERCEPT platelets in 100% plasma, collected on the Trima platform 
and stored for 5 days.  The results of this study showed that platelet aliquots processed with 
variations of the BEST protocol for preparing platelet samples prior to radiolabeling [Variant 1 
(hard spin only) or Variant 2 (addition of buffered ACD-A/saline instead of ACD-A and 
recombining slow and fast spin pellets)] led to improved in vitro platelet pH levels, yield 
recovery and quality, when compared to the samples processed with the original 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
BEST version 4.2.1 method. Platelet aliquots prepared with either Variant 1 or Variant 2 
modifications exhibited similar in vitro characteristics, but slightly differed with respect to 
platelet yield recovery (proportion), platelet lysis, platelet activation and metabolism. 
Cumulatively, the study results supported the use of either variant method as an improved 
platelet sample preparation method for stored apheresis platelets compared to the original 
BEST version 4.2.1 method.  Variant 1 was selected for further study as the use of a soft spin 
and recombining of pellets in Variant 2 was considered redundant. 
Following the completion of VAL 00376, and based on FDA concerns that the Variant 1 
procedure would result in higher RBC and WBC contamination and therefore might provide 
misleading results for platelet recovery and survival, Cerus conducted another study to 
characterize the RBC and WBC contamination level of samples prepared using either the 
BEST or Variant 1 methods (REL 00556). 
Data from REL 00556, provided in Table 4, confirm that when the BEST protocol is 
performed on INTERCEPT platelets, stored for 7 days, the in vitro recovery of platelets is 
reduced by ~29.4% (BEST 2391 ±381: Variant 1 3389 ±378), raising the possibility that 
radiolabeling would be biased by the labeling of a selected subset of platelets when using the 
BEST protocol. Although the manual and flow cytometry-based RBC counts showed that 
apheresis platelet samples prepared with the Variant 1 procedure have higher RBC and WBC 
contamination than the BEST protocol, the levels are well below levels considered to be 
material to the outcome of radiolabeling studies.  Both the BEST and Variant 1 protocols 
resulted in < 1:10,000 contamination of the platelet preparations with either RBC or WBC by 
cell count and <1:1,000 by cell volume (assuming that the Mean Platelet Volume was 10% of 
the volume of an RBC or lymphocyte).   
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Table 4 
Comparison of Platelet, RBC and WBC Count in Platelet Samples Prepared 
for Radiolabeling Using the BEST (WB Derived Fresh Platelets and INTERCEPT Stored 
Platelets) and Variant 1 Method (INTERCEPT Stored Platelets) (Study REL 00556) 
 
Fresh Whole Blood 
(N = 12) 
INTERCEPT Apheresis Unit (Day 7) 
(N = 12) 
t-Test (D7 
BEST vs D7  
Variant 1) 
Assay 
Method 
Input Units 
BEST 
Input 
Units 
BEST 
Variant 1 
Automated 
Platelet Count, 
103/µL 
Advia 120 
214 ±53 
(166 - 338) 
1376 ±597 
(320-2537) 
1111 ±148 
(906-1481) 
2422 ±372 
(1961-3338) 
3446 ±419 
(3027-4431) 
<0.001 
Automated 
RBC Count, 
103/µL 
Advia 120 
3904 ±286 
(3545 - 
4320) 
169 ±85 
(45-315) 
100 ±23 
(70-150) 
165 ±40 
(110-255) 
248 ±44 
(195-350) 
<0.001 
Manual RBC 
Count, 103/µL 
Hemo-
cytometer 
ND 
1.16 ±0.69 
(0.23-2.79) 
0.05 ±0.08 
(0.01-0.33) 
0.02 ±0.03 
(0.00 - 0.10) 
0.09 ±0.14 
(0.01 - 0.54) 
0.07 
Flow 
Cytometry 
based RBC 
count, 103/µL 
CD235a 
Antibody 
3926 ±463 
(3271 - 
4816) 
0.19 ±0.22 
(0.01 - 
0.84) 
0.01 ±0.02 
(0.00 - 
0.07) 
0.02 ±0.03 
(0.00 - 0.07) 
0.11 ±0.10 
(0.01 - 0.27) 
0.003 
Flow 
Cytometry 
based White 
Cell Count 
WBC,  per µL 
Leucocount 
6603±1220 
(4953 - 
8468) 
37±36 
(4-135) 
0.1 ± 0.1 
(0.0 - 0.2) 
0.1 ± 0.1 
(0.0 - 0.3) 
0.2 ± 0.3 
(0.0 – 1.0) 
0.15 
 
The labeling efficiency using Chromium-51 has been reported to be 10-fold lower for platelets 
compared to RBCs, 9% versus 90% (Baldini 1960), whereas Indium-111 will preferentially 
label platelets compared to RBCs or WBCs (Mountford 1985).  Even with the differences in 
labeling efficiency for Chromium-51 (which would represent half of the samples collected for 
INTERCEPT stored platelets, as the radiolabeling is randomized between Test and Control for 
Chromium-51 and Indium-111). Cerus data for RBC contamination levels suggests that the 
contribution of the RBC levels between stored apheresis platelets processed with the BEST or 
Variant 1 protocols represents a scientifically insignificant difference (<1% of Chromium-51 
labeling). 
Furthermore, the BEST protocol includes one final sample on Day 10, 11, or 12. The last 
sample is called the “baseline” sample and is used to correct for inadvertent labeling of other 
blood components (BEST 2005). The rationale for this sample is that contaminating RBCs 
have a longer in vivo lifespan than platelets and that any radioactivity remaining in the 
circulation after Day 10 must be from contaminating RBCs in the sample preparation or from 
in vivo elution for the radiolabel from platelets and labelling of other blood components.  

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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In summary, RBC contamination for stored, INTERCEPT platelets represents approximately 
0.0008% or 0.0035% of the cellular content in the sample, using the BEST or Variant 1 
procedures, respectively and therefore is not scientifically relevant as a source of 
contamination. In comparison, the RBC contamination of the fresh WB derived platelets is 
approximately 0.0085% of the cellular content and the WBC contamination is 0.0035% of the 
cellular content for WB derived platelets (versus 0.000000044% for stored, INTERCEPT 
apheresis platelets).  
CLI 00127 will evaluate both Variant 1 and the BEST procedure, which is the current standard 
for preparing stored platelet samples for recovery and survival studies. RBC contamination 
will also be assessed using a Ficoll gradient technique as a secondary confirmation of RBC 
contamination levels. 
3.3 
Summary of Potential Risks and Benefits 
3.3.1 Benefits of Study Participation 
There are no direct benefits to the subjects in this study. 
3.3.2 Risks of Study Participation 
A summary of the safety experience with INTERCEPT platelets is provided in the Package 
Insert (SPC 00701-AW v3.0 INTERCEPT Blood System for Platelets – Dual Storage (DS) 
Processing Set). The cumulative experience suggests no excess treatment-related morbidity 
associated with the transfusion of INTERCEPT PCs compared to conventional PCs. With the 
limited exposure to autologous platelets in the study proposed herein (approximately 10 to 
30 mL infusion), systemic risks are considered unlikely. 
3.3.2.1 Risk of Receiving an Incorrectly Labeled Platelet Component 
PCs will be prepared, labeled, and tracked using site SOPs to ensure that appropriate 
identification of study components is maintained at all times. Verification of each subject’s 
platelet component will occur prior to infusion as an additional check on component identity.  
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
3.3.2.2 Risk of Transfusion-Transmitted Infectious Disease 
The risk of transfusion-transmitted infections (TTI) is considered minimal for study subjects 
who will receive approximately 10 to 30 mL of washed radiolabeled autologous Test and 
Control platelets. All standard viral pathogen testing performed routinely by the Blood Centers 
will be performed. Since subjects will be receiving autologous platelets that have been 
screened for TTIs, the risk of infection transmission is minimal.  All Test PCs will be treated 
with the INTERCEPT system which has demonstrated high levels of bacterial inactivation 
efficacy through 5 days and 7 days of storage (Wagner, et al. 2015) and four years safe 
experience with 7 day stored INTERCEPT PC in Switzerland. Bacterial contamination is 
possible during radiolabeling due to required use of an open system. However, only a small 
aliquot of labeled platelets will be re-infused shortly after labeling, thus the risk of bacterial 
proliferation due to contamination during the radiolabeling procedure is minimized. Based on 
laboratory studies demonstrating inactivation of viruses and bacteria, the infectious disease 
risk to recipients of Test platelets is reduced compared with that of conventional platelet 
components.  
3.3.2.3 Risk of Transfusion Reaction 
Transfusion reactions known to occur following transfusion of conventional platelets may 
occur following infusion of study platelets (e.g., fever, chills, itching, rash, hives, 
bronchospasm, nausea/vomiting, hypertension/hypotension, TRALI, TACO, and anaphylaxis). 
The risk of experiencing a transfusion reaction is considered minimal from the small 
autologous infusions used in this study (approximately 10-30 mL).  
3.3.2.4 Risk of Apheresis Collection 
Risks associated with the apheresis collection of platelets include: blood pressure changes, a 
temporary decrease in platelets, a small loss of white blood cells, problems with vein access 
(including pain, bleeding, and infection at the catheter site), effects of the anticoagulant on the 
donor's calcium level (including paresthesias from citrate-induced hypocalcemia), and allergic 
reactions to the anticoagulant or other products used, which may be life-threatening.  On very 
rare occasions, risks associated with the apheresis collection include nerve damage, serious 
problems and death. Allergic reaction due to iodine allergy is possible if an iodine solution is 
used to cleanse the phlebotomy site to meet standards in 21 CFR 640.4(f). Blood pressure 
changes can sometimes cause nausea, fatigue, and dizziness. Platelet loss may increase the risk 
of bleeding from cuts or wounds.  Venous access problems can cause bruising referred to as a 
hematoma. While donating, a supply of calcium antacid tablets is usually kept close by to 
replenish the calcium lost. Because the anticoagulant works by binding to the calcium in the 
blood, a donor's levels of calcium - and especially of active calcium ions - decrease during the 
donation process. The lips may begin to tingle or there may be a metallic taste; since calcium 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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enables the function of the nervous system, nerve-ending-dense areas (such as the lips) are 
susceptible, at least during the donation process. Unusually low calcium can cause more 
serious problems such as fainting, nerve irritation and short-duration tetany. Such an acute 
hypocalcemia is usually due to low calcium levels prior to donation, aggravated by the 
anticoagulant. Hypocalcemia can be curtailed by modestly increasing dietary calcium intake in 
the days prior to donation. Nerve damage which is more rarely observed may result in 
numbness, pain or paralysis.  Serious problems are extremely rare and may include heart attack 
and stroke. The apheresis procedure can also result in a need for extended medical treatment 
and can be fatal.  Apheresis donors are routinely monitored during the long donation process. 
3.3.2.5 Risk Related to Whole Blood Collection 
Use of experienced phlebotomists will reduce the likelihood of these types of injuries. Blood 
collection may be associated with hematoma formation, local irritation, or infection. Local 
care can be given to prevent hematoma formation, according to standard medical practice. 
3.3.2.6 Risk Related to Infusion Procedure 
The infusion procedure may be associated with hematoma formation, local irritation, or 
infection. Local care can be given to prevent hematoma formation, according to standard 
medical practice. 
3.3.2.7 Risk Related to Radiation Exposure 
111Indium Oxine (111In) and Na251CrO4 (51Cr) are routinely used for radiolabeling and infusion 
of fresh or stored platelets in humans. The amount of radiation that the subjects will receive in 
each study infusion is estimated to be up to approximately 60 mrem, below the annual 
maximum limits typically considered to be safe. 
No known risks are associated with 51Cr administration at the level of chromium exposure 
used in this study. Allergic dermatological reactions have been reported in association with 
111In. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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4.0 
TRIAL OBJECTIVE 
The principle objective of this study is to evaluate the hypothesis that INTERCEPT Platelets in 
100% plasma stored for 5 or more days (up to 7 days) after apheresis collection retain 
sufficient viability for therapeutic transfusion efficacy. The post-infusion recovery and 
survival of radiolabeled 7- day INTERCEPT platelets (Test) stored in 100% plasma will be 
measured in comparison to their “fresh” radiolabeled platelet (Control) according to FDA 
guidance for platelet testing (FDA 1999) in Stage 2 of this study protocol.  
A secondary objective is to compare the recovery and survival results for Test platelets 
prepared for radiolabeling using the BEST method or Variant 1 in Stage 1 of this study 
protocol. This comparison will evaluate the hypothesis that preparation methods prior to 
radiolabeling may influence in vitro quality of the radiolabeled platelets and post-infusion 
viability outcomes.  In addition, in vitro function will also be evaluated for the stored Test 
INTERCEPT platelets. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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5.0 
TRIAL DESIGN 
5.1 
Overall Trial Design and Plan 
The study population will consist of healthy subjects who meet the FDA, AABB, and site-
specific research donor eligibility criteria for an apheresis platelet collection.   
In each stage, apheresis platelets (single or double) will be collected in 100% plasma on the 
Trima Accel® Automated Blood Collection system.  Each study apheresis collection will be 
processed using the INTERCEPT Blood System for Platelets; apheresis platelets containing a 
platelet dose of 3.0 to 7.9 x1011 platelets in 300 to 420 mL of plasma will be processed using 
the INTERCEPT Dual Storage (DS) processing set. The INTERCEPT process will begin on 
either the day of collection (Day 0) or the day following collection (Day 1); illumination must 
occur within 24 hours after the end of collection. Test platelet components will be stored for 
up to 7 days, after collection, in 100% plasma. In vitro platelet function will be evaluated on 
Days 0/1 (pre-treatment) and at end of storage (Day 7) for both stages (Table 11).  
At the end of storage, duplicate aliquots of Test platelets will be aseptically removed from 
each subject’s INTERCEPT platelet storage container and prepared, in tandem, for 
radiolabeling using either BEST version 4.2.1 method (Stage 1) or Variant 1 modification 
(Stages 1 and 2).  One of the Test platelet sample aliquots will be used to assess the in vitro 
quality prior to and following the pre-radiolabeling platelet sample preparations. The indices to 
be measured in Stage 1 are volume, pH22°C, CD62P, platelet count, RBC count, and WBC 
count (Table 10).  Assessments of these indices will enable the determination of platelet 
processing recovery due to each sample preparation method and evaluation of residual RBC 
and WBC contamination in samples prior to radiolabeling. In Stage 2, only platelet processing 
recovery (calculated from volume and platelet count) and pH22°C measured following the pre-
radiolabeling platelet sample preparations. The second Test platelet sample aliquot will be 
used for radiolabeling. 
The study will be performed in two stages (Table 5). Stage 1 is a randomized, 2-period 
crossover design. Test platelets stored for 7 days will be radiolabeled using either the BEST or 
Variant 1 methods (depending on the period and randomization scheme for the Test platelets) 
for 12 healthy subjects (6 subjects from each site). The recovery and survival for Test platelets 
prepared with the BEST and Variant 1 methods will be compared with each other and against 
the fresh platelet Control. Stage 2 is a single arm study in which all Test platelets will be 
prepared for radiolabeling using the Variant 1 methodology. The recovery and survival for 
Test platelets will be compared against the fresh platelet Control. Recovery and survival of 
INTERCEPT platelets will be assessed after 7 days of storage for 24 evaluable subjects (target 
12 subjects with a minimum of 8 at a single site).   

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Up to a total of 36 subjects with evaluable (Test and Control) recovery and survival data may 
be obtained.  Randomized subjects who do not have both paired (Test and Control) recovery 
and paired survival data for a given stage or who are unable to provide a second matched 
donation for a cross-over stage will be replaced, unless the enrollment goal is met.   
Table 5 
Description of Study Stages 
 
 
Period 1 
Period 2 
 
 
Test, INTERCEPT 
Platelets 
Control, 
Fresh 
Platelets 
Test, INTERCEPT 
Platelets 
Control, 
Fresh 
Platelets 
Stage 
Arm 
Storage 
Duration 
(post 
collection) 
Sample 
Prep 
Sample 
Prep 
Storage 
Duration 
(post 
collection) 
Sample 
Prep 
Sample 
Prep 
Stage 1a 
Arm 1  
7 days 
Variant 1 
(n=6) 
BEST  
(n=6) 
7 days 
BEST 
(n=5) 
BEST  
(n=5) 
Arm 2  
7 days 
BEST 
(n=7) 
BEST  
(n=7) 
7 days 
Variant 1 
(n=6) 
BEST  
(n=6) 
Stage 2 
Single Arm 
(n=24)b 
7 days 
Variant 1 
BEST 
Not Applicable, Single Arm 
a   Based on correspondence with FDA (BQ200481, July 8, 2020), Stage 1 was not completed. The n represents the number of subjects 
which have completed the period. 
b  Stage 1 subjects with evaluable Variant 1 method data will contribute to the requirement of the 24 subjects for Stage 2. 
 
On the day corresponding to the end of storage for the Test component, healthy subjects will 
return to the site, and 43 (±2) mL of whole blood (WB) will be drawn into a syringe containing 
9 mL of Anticoagulant Citrate Dextrose Solution, Formula A (ACD-A). The sample will be 
used to prepare fresh Control platelets from platelet rich plasma following the BEST 
methodology.  In addition, a blood sample in EDTA will be drawn for use in determination of 
radiolabel elution. 
Test and Control will be randomly radiolabeled with either 51Cr as sodium radiochromate 
(Na251CrO4) or 111In as indium oxine, depending upon randomization period and assignment. 
Subjects will be randomized with equal probability to the radiolabeling sequences  
(111In/51Cr vs. 51Cr/111In) for Test/Control. After radiolabeling, the autologous Control and Test 
platelet samples will be simultaneously infused into the subject.  
Blood samples will be drawn immediately before infusion and for radioactivity measurements 
at 1 hour ± 15 min and 2 hours ± 15 min post-infusion (Day 0), and 6 more samples will be 
drawn at 1, 2, 3, 4 (or 5 or 6), 7 (or 8), and 11±1 days post-infusion (DPI), at approximately 
the same time of day as the radiolabeled platelet infusion was administered (±4 hours). 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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For subjects enrolled in the Stage 1 cross over study, there will be a minimum washout period 
of four weeks between the two study periods (e.g., four weeks after the last blood sample at 
11±1 DPI in period 1). Subjects will be monitored for safety (adverse events) from the first 
apheresis procedure until 24 hours after the last DPI blood sample is drawn.  
Stage 1 is a randomized, 2-period crossover design. Test platelets stored for 7 days will be 
prepared for radiolabeling using either the BEST or Variant 1 methods (depending on the 
period and randomization scheme for the stored apheresis platelets) for up to 12 healthy 
subjects. The post-infusion recovery for Test platelets prepared with the BEST and Variant 1 
methods will be compared with each other and against the fresh platelet Control. Stage 1 will 
have up to 12 completed pairs. 
Stage 2 is a single arm study in which all Test platelets will be prepared for radiolabeling using 
the Variant 1 method.  Recovery and survival of Test platelets will be assessed after 7 days of 
storage for 24 evaluable subjects; Stage 1 Variant 1 data, will be applied to Stage 2 to achieve 
24 evaluable pairs based on FDA feedback (BQ200481).  The goal of this stage is to complete 
the qualification of Test platelets collected on the Trima separator and stored for 7 days in 
100% plasma using the Variant 1 procedure. 
The duration of the study for each Stage 1 subject will be 17-19 days following apheresis per 
period with an initial screening window of up to 15 days, or a total duration of approximately 
77 to 81 days. For subjects enrolled in Stage 2 the duration is approximately 32 to 34 days.  
5.2 
Randomization and Blinding 
Cerus will generate the randomization scheme separately for each study stage to be executed 
by the blood centers. In this study, eligible subjects who are enrolled in Stage 1 will be 
randomized in 1:1 ratio to one of the two platelet preparation procedure sequences for Test 
platelets (BEST/Variant 1 or Variant 1 /BEST).  Subjects will also be randomized across 
radiolabeling sequences (111In/51Cr or 51Cr/111In for Test/Control) for both Stage 1 and Stage 2. 
In addition, an equal number of subjects will be targeted at each study site for both Stage 1 (6 
subjects per site) and Stage 2 (12 subjects with a minimum of 8 at a single site). Subjects will 
receive both Test and Control platelets at the same time.  To reduce the potential confounding 
effect from radiolabel for the BEST vs. Variant 1 comparison in Stage 1, the same randomized 
radiolabeling sequence (either 51Cr or 111In for Test platelets) will be utilized throughout both 
donation periods for a given subject as applicable. Randomized subjects who do not have both 
paired (Test and Control) recovery and paired survival data for a given stage or who are unable 
to provide a second matched donation for a cross-over stage will be replaced, unless the 
enrollment goal is met.   

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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In this open-label study, the sites and subjects will not be blinded to the randomization 
assignment. 
5.3 
Treatment and Dose 
5.3.1 Administration of Study Product 
The study platelets (approximately 10 to 30 mL of washed radiolabeled fresh [Control] and 7-
day stored autologous radiolabeled platelets [Test]) are administered by intravenous infusion 
in a peripheral vein using a butterfly infusion needle. 
5.3.2 Preparation of the Study Test Platelet Component 
5.3.2.1 Apheresis Platelet Collection 
Study subjects who qualify to participate in either stage of the study will provide one single or 
double apheresis platelet collection (Stage 2) or two single or double apheresis platelet 
collections (Stage 1) as specified in Section 5.3.6.2.  All study apheresis donations will be 
collected in 100% plasma on the Trima Accel® automated blood collection system according 
to blood center SOPs and the manufacturer’s instructions, with leukocyte reduction by 
centrifugation as part of the collection process and with anticoagulant ACD, using FDA 
approved collection sets (Trima product code: 80400 or 80440). A small sample may be 
acquired to obtain the subject’s platelet count.  
The subject’s platelet count and body mass prior to the first donation will determine if a single 
or double-dose collection will be performed. For Stage 1 each subject will provide the same 
type of apheresis collection for both study apheresis platelet collections. If a subject is unable 
to provide a second evaluable donation (two attempts, at least two weeks apart, to obtain a 
second donation can be made if the subject meets the eligibility requirements for donation), the 
study subject will be replaced.  
After collection, the platelet components will be handled following the manufacturer’s 
instructions which include static rest followed by continuous agitation at 20°C to 24°C. 
Platelets will have an RBC content <4x106/mL and should be free of visible aggregates prior 
to INTERCEPT treatment. Platelet components with an RBC content >4x106/mL will be 
excluded from the study. 
At several different steps in the preparation of the Test component, the component volume will 
be measured by weight. The tare weight for each of the different platelet containers (empty dry 
container with standardized tube length) will be used to determine the net product weight. Tare 
weights will be reported.  
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
Platelet volume (mL) will be determined using the following equation:  
• [Gross weight (g) of the component – tare weight of the container (g)] ÷ specific 
gravity of platelets]  
• The specific gravity of platelets used for calculations for this protocol will be:  
• 100% plasma: 1.03 g/mL Apheresis Platelets 
5.3.2.2 Preparation of Test Platelets 
Platelet input components will be sampled and evaluated for parameters described in 
Table 11.  
Treatment with INTERCEPT (Figure 2) will begin within 24 hours of collection. The 
processing steps described in SPC 00701-AW v3.0, (INTERCEPT Blood System for 
Platelets-Dual Storage (DS) Processing Set) will be followed, unless superseded by 
instructions presented in this protocol (i.e. sampling of components and extended storage 
durations). 
Each Test input component will contain 3.0 to 5.2×1011 platelets in 300-390 mL in 100% 
plasma (single collection) or 5.3 to 7.9×1011 platelets in 375-420 mL in 100% plasma (single 
or double collection). If the input platelet component volume is greater than 420 mL, the 
volume will be adjusted to 300 to 420 mL by sterile connection to an empty container and 
removing the excess volume, which will be discarded.  The Test input platelet dose and 
volume should be comparable for both treatment periods of Stage 1.   
Each Test input component will be connected to the tubing of the INT25 Dual Processing Set 
using a sterile connection device (SCD). The final storage containers of the INTERCEPT set 
will be labeled “Test-A” for single collections and randomly labeled “Test-A” and “Test-B” 
for collections with input doses ≥5.3×1011 platelets/unit.  
Amotosalen will be added to the component by passing the entire contents of the Test input 
component through the amotosalen container and into the illumination container. After the 
component is mixed and air has been returned to the input container, the tubing connecting the 
amotosalen container to the illumination container will be sealed and the amotosalen container 
and the original platelet container will be detached.  
Test in-process platelet components will then be illuminated with a target dose of 3.9 J/cm2 
UVA treatment on the INTERCEPT Illuminator. A treatment report will be printed and 
attached to the processing batch production record.   
Following illumination, Test in-process platelets will be transferred to the container with the 
CAD, the illumination container will be detached, and the platelets will be placed in an 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
incubator at 20°C to 24°C on a flatbed platelet agitator with rotation speed of ≥60 rpm. The 
time the platelets are transferred to the container with the CAD and the time the CAD is placed 
into agitated storage will be recorded.  
The duration of agitated storage with the CAD will be 12 to 24 hours. The time when the 
container with the CAD is removed from agitated storage will be recorded. For cross-over 
stages the CAD duration for the second period should be within 2 hours of the first period.  
The container with the CAD will be hung and platelets will be transferred by gravity into 1 or 
2 storage containers and any air returned to the empty container with the CAD. The 
INTERCEPT storage containers and connected tubing will be weighed; the net weight will be 
used to determine the total post INTERCEPT volume. This volume will be used for 
determination of platelet dose and volume recoveries. For input platelet dose greater than 
5.3×1011, the platelet volume will be divided as evenly as possible (by weight) to make 2 equal 
INTERCEPT platelet (Test) components, randomly designated “Test-A” and “Test-B” that 
will remain connected during storage or will be stored in two separate containers for input 
platelet dose greater than 7.1×1011 according to the Instructions for Use. The empty container 
with the CAD will be detached and discarded using a heat seal technique to preserve sterility. 
The individual INTERCEPT storage containers will be weighed for calculation of post-
treatment volume and the post INTERCEPT sample will be removed as described in 
Section 5.3.2.1 for assessment of the indices described in Table 11. 
All INTERCEPT platelets (Test) will be stored under standard conditions of continuous 
agitation using licensed platelet agitator and temperature control (20°C to 24°C) until the time 
of radiolabeling on Day 7 post- collection.  
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Flow Diagram of the INTERCEPT Process for Platelets 
Addition of amotosalen  
• 
Weld the tubing from the platelet apheresis 
container to the amotosalen container tubing 
using a sterile connection device. 
• 
Hang the platelet apheresis container, break 
cannulas on both ports of the amotosalen 
container and allow the platelets to flow 
through the amotosalen container and into the 
illumination container. 
 
 
 
 
Illumination 
• 
Illuminate the platelet/amotosalen mixture 
using an INTERCEPT Illuminator. 
 
 
 
 
Reduction of residual amotosalen 
• 
Hang the illumination container. 
• 
Break the cannula on the exit port of the 
illumination container and allow platelets to 
flow into the compound adsorption device 
(CAD) container.  
• 
Disconnect and discard the illumination 
container and agitate the container with the 
CAD at 20°C to 24°C on a flatbed platelet 
agitator with rotation speed of ≥60 rpm for 12-
24 hours. 
 
 
 
 
Preparation of Test platelet 
components  
• 
Break the cannula on the exit port of the 
container with the CAD and allow platelets to 
flow into one (5.2×1011 platelets) or two 
(≥5.3×1011 platelets) storage containers. 
• 
Seal tubing and remove treated platelet 
components. 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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disclosure without express written consent from Cerus Corporation. 
5.3.2.3 Labeling  
5.3.2.3.1 Test Platelet Components  
During apheresis collection, processing, and infusion of autologous platelets, the platelet 
components will be properly labeled to definitively identify the subject and ensure correct 
infusion of autologous platelets. Minimal information to be provided on the label will include: 
• IDE number (BB-IDE 6200) 
• Protocol number (CLI 00127) 
• Site/Subject ID 
• Platelet preparation and radiolabeling method (BEST or VAR 1)  
• Date of collection 
• Study Stage 
• End of Storage Date (based on 7-day Storage Duration) 
In addition, for Test platelet components stored in two containers, the label will be identified 
as “Test-A” or “Test-B.”  
All study platelet components will contain the label: 
Caution: Investigational Product - Limited by United States Law to Investigational Use 
5.3.2.3.2 Platelet Samples 
The minimal information to be provided on the label of study samples will include:  
• Protocol Number (CLI 00127) 
• Site/Subject ID 
• Platelet preparation and radiolabeling method (BEST or VAR 1) 
• Treatment group (Test or Control) 
• Timepoint (Input, Post INTERCEPT, Day 7, and DPI) 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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5.3.2.4 Radiolabeling of Test 
On the day of scheduled radiolabeling and infusion (Day 7 post-apheresis), samples will be 
aseptically removed from the component for radiolabeling and in vitro platelet function 
testing.  The Test platelets are prepared for radiolabeling using either the BEST version 4.2.1 
method (Stage 1; Appendix B) or the Variant 1 method (Stage 1 and Stage 2; Appendix C). 
The Test platelet sample will be evaluated prior to and post preparation for radiolabeling 
(Table 10). 
5.3.2.5 Preparation of Control Platelets – Fresh Platelets 
On the scheduled day of radiolabeling/infusion approximately 43 (±2) mL of whole blood is 
collected from the subject in a syringe containing ACD-A to prepare the Control platelets 
(fresh platelets). The fresh platelets are separated from the whole blood by centrifugation to 
prepare platelet rich plasma.  The Control platelets will be labeled with the alternate 
radionuclide to the one used for the paired Test platelets. The Control platelets are radiolabeled 
according to the BEST version 4.2.1 method (Appendix B).  
5.3.2.6 Platelet Infusion 
The study platelets (approximately 10 to 30 mL of washed radiolabeled fresh [Control] and 7-
day stored, washed, radiolabeled autologous platelets [Test]) are administered by intravenous 
infusion in a peripheral vein using a 19-gauge butterfly infusion needle.  
5.3.3 Duration of Subject Participation 
Within 15 days prior to participating in either study stage, subjects will be screened for 
eligibility. For each enrolled subject, study participation will include 17-19 days following the 
apheresis platelet collection, depending on the day of the last blood sample for radioactivity.  
For Stage 2 the total duration will be approximately 32-34 days; for Stage 1 with two study 
periods (crossover), total duration will be approximately 77-81 days, including the interim 
wash out interval.  
The study schematic design is displayed in Table 6.

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT 
Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days 
 
CLI 00127, v5.0 
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Table 6 
Study Schema 
Period (order 
randomly 
assigned, stratified 
by site) 
Screening 
Apheresis 
Collection 
(TRIMA 
collector) 
INTERCEPT 
Treatment 
(Day post 
collection) 
Sampling, Radio-
labeling, Infusion, 
Subject Blood 
Sampling 
(Day post collection) 
Subject Blood Sampling 
(Day Post Infusion) 
Stage 1:  7 days storage, BEST and Variant 1 
Period x 
(Variant 1) 
Day -15 to 0, 
or  
4 week 
washout 
Day 0 
Day 0-1 
Day 7 
             DPI 0 a 
DPI 1b 
DPI 2 
DPI 3 
DPI 4  
(or 5 
or 6)b 
DPI 7 
(or 8)  
DPI 
11±1 b 
Period y 
(BEST) 
Day -15 to 0, 
or  
4 week 
washout 
Day 0 
Day 0-1 
Day 7   
             DPI 0 a 
DPI 1b 
DPI 2 
DPI 3 
DPI 4 
(or 5 
or 6)b 
DPI 7 
(or 8) 
DPI 
11±1b 
Stage 2: 7 days storage, Variant 1 only 
NA 
Day -15 to 0 
Day 0 
Day 0-1 
Day 7 
with Variant 1  
 
              DPI 0 a 
DPI 1 
DPI 2 
DPI 3 
DPI 4 
(or 6) 
DPI 7 
DPI 
11±1 b 
a 
Samples will be acquired pre infusion and approximately 1 and 2 hours post infusion on DPI 0.  
b 
A portion of the subject’s radiolabeled whole blood sample will be subjected to a Ficoll gradient to allow characterization of RBC contamination. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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5.3.4 Schedule of Assessments and Procedures 
The study procedures and assessments are displayed in Table 7.  The following assessments 
should be completed at the designated time period(s). 
Table 7 
Study Assessments 
SCREENING AND ENROLLMENT 
Both stages:  
Day -15 to 0 
 
Subject 
Screening 
• 
Sign informed consent form 
• 
Medical history and demographics 
• 
Blood donor physical exam (including height, weight, and vital 
signs: temperature, sitting blood pressure and heart rate) 
• 
Concomitant medications (including drugs of abuse) and 
nicotine and/or cannabis inquiry 
• 
Urine drug screening test 
• 
Blood sample for hematology and chemistry panels (see list of 
specific parameters in Table 9)   
• 
Blood donor screening panel (including ABO, Rh type, and 
viral screening panel: HIV, HBV, HCV, HTLV, syphilis, and 
WNV) 
• 
Urine or blood pregnancy test (for females of child-bearing 
potential)  
• 
Review of inclusion/exclusion criteria 
PLATELET APHERESIS COLLECTION AND STORAGE  
(Stage 1 [each period] and Stage 2) 
Both stages: Day 0 
Subject Procedures Prior to Apheresis Collection  
• 
Weight  
• 
Vital signs  
• 
Blood sample for hematology and chemistry panels a (including 
subject platelet count) (see list of specific parameters in 
Table 9)  
• 
Concomitant medications and nicotine and cannabis review  
• 
Update baseline medical history 
Apheresis collection 
• 
Autologous single or double apheresis platelet collection and 
concurrent plasma using the Trima cell separator 
• 
Collected and suspended in 100% plasma  
• 
AEs and SAEs 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Both stages: Day 0-1 
Platelet Component Procedures- Prior to INTERCEPT Treatment 
(In Vitro Platelet Assessments, see Table 11) 
• 
Visual inspection to confirm absence of platelet aggregates 
• 
Confirm RBC content <4×106 
• 
Component weight pre and post-sampling (for volume 
calculation) 
Platelet Component -Initiate INTERCEPT Treatment  
Both stages: Day 1-2  
Platelet Component Procedures - Post INTERCEPT Treatment 
• 
Component weight 
• 
Component count 
BACTERIAL TESTING 
Stage 1 (each period): 
Day 4, 5 or 6 
 
Stage 2: Day 4, 5 or 6 
A sample for bacterial screening is withdrawn 1-3 days before the 
scheduled radiolabeling/infusion, although bacterial testing is not 
routinely required for INTERCEPT PCs stored for 5 days  
(see Table 11). 
RADIOLABELING AND INFUSION OF AUTOLOGOUS PLATELET ALIQUOTS 
Stage 1 (each period): 
Day 7 
 
Stage 2: Day 7 
Subject Procedures On the Day of Infusion (Prior to Infusion)  
• 
Weight 
• 
Vital Signs  
• 
Urine or blood pregnancy test for females 
• 
Blood sample for hematology and chemistry panels (see list of 
specific parameters in Table 9)  
• 
Collect blood sample for preparation of fresh platelets (Control) 
• 
Collect blood sample in EDTA for determination of radiolabel 
elution 
• 
Concomitant medications and nicotine and/or cannabis review 
• 
Collect AEs and SAEs  
Test Platelet Component Procedure Prior to Radiolabeling 
• 
Obtain aliquot for radiolabeling 
• 
Platelet component must pass all release criteria (Table 8) in 
order to be radiolabeled/infused 
Platelet Component - In Vitro Platelet Assessments  
• 
Obtain sample for in vitro assessments (Table 11)  
Radiolabeling of Test Platelet Aliquots 
• 
Prepare sample for radiolabeling following BEST or Variant 1 
procedure (Stage 1) or Variant 1 (Stage 2) 
Assessment of platelet sample prior to preparation with BEST or Variant 
1 method and immediately before to radiolabeling (Table 10)  
• 
Volume (Stages 1 and 2) 
• 
Platelet count (Stages 1 and 2) 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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• 
RBC Count (Stage 1) 
• 
WBC count (Stage 1) 
• 
pH22°C (Stages 1 and 2) 
• 
CD62P (Stage 1) 
• 
Radiolabel Test platelets using method and labeling 
assignments based on randomization  
Radiolabeling Control Platelet Aliquots 
• 
Prepare fresh platelet sample (Control) 
• 
Radiolabel Control platelets using BEST method and labeling 
assignments based on randomization  
Radioactive Standard 
• 
Reserve samples of radiolabeled combined injectate before 
infusion to be used as a radioactive standard (pre-infusion) 
 
Subject Procedures - Infusion of Study Platelets 
• 
Vital signs (pre-infusion) 
• 
Infuse radiolabeled platelet aliquot from both the autologous 
apheresis collection treated with INTERCEPT Blood System 
and stored 7 days (Test) and autologous fresh whole blood 
derived platelets (Control) 
• 
At approximately 0 (pre-infusion sample) and 1 hour ± 15 min 
and 2 hours± 15 min post-infusion: 
o Vital Signs  
o Blood sample to measure radioactivity to calculate 
recovery and survival 
o Concomitant medications and nicotine and/or cannabis 
review  
o Collect AEs and SAEs 
o Discharge 
Both Stages:  1, 2, 3, 4 
(5 or 6), and 7 (or 8) 
DPI 
Within ±4h of the 
infusion time on 
0 DPI 
(Stage 1-Day 7 and 
Stage 2-Day 7) 
Subject Procedures – Post-Infusion  
• 
Blood sample to measure radioactivity to calculate recovery 
and survival and to characterize RBC contamination 
• 
Vital Signs  
• 
Concomitant medications and nicotine and/or cannabis review 
• 
Collect AEs and SAEs 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Both Stages   
11± 1 DPI 
 
Within ±4h of the 
infusion time on 0 DPI  
(Stage 1-Day 7 and 
Stage 2-Day 7) 
Subject Procedures – Post Infusion Final Visit  
• 
Physical examination 
• 
Vital Signs  
• 
Weight 
• 
Blood sample to measure radioactivity to calculate recovery 
and survival and to characterize RBC contamination  
• 
Blood sample for hematology and chemistry panels (see list of 
specific parameters in Table 9)  
• 
Urine or blood pregnancy test for females  
• 
Concomitant medications and nicotine and/or cannabis review 
• 
Collect AEs and SAEs 
a 
Hematology and chemistry panels do not need to be repeated if screening labs are performed within 7 days prior to 
apheresis. 
5.3.5 Subject Screening  
5.3.5.1 Before Each Study Stage (Day -15 to 0) 
Prior to participating in the study, healthy volunteer subjects will be screened for eligibility. 
Subject screening procedures will be performed within 15 days preceding the apheresis 
collection. Screening procedures will include the following: 
• Obtain signed informed consent 
• Medical history and demographics 
• Blood donor physical exam (including height, weight, and vital signs: temperature, 
sitting blood pressure, and heart rate) 
• Concomitant medications (including drugs of abuse), and nicotine and/or cannabis 
inquiry 
• Urine drug screening test 
• Blood sample (~13 mL) collection for laboratory tests: hematology and chemistry 
panels (see list of specific parameters in Table 9)  
• Blood sample (~24 mL) collection for donor screening panel (including ABO, Rh type, 
and viral screening panel: HIV, HBV, HCV, HTLV, syphilis, and WNV) 
• Urine or blood pregnancy test (for females of child-bearing potential) 
• Review of inclusion/exclusion criteria 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Subjects who meet all inclusion and none of the exclusion criteria will visit the laboratory as 
specified in the Schedule of Assessments (see Table 7) and Study Schema (Table 6) for each 
stage of the study. 
 Platelet Apheresis Collection and Storage
5.3.6.1 Day 0: Prior to Apheresis Collection  
Prior to apheresis collection in any study stage/period, the donor weight and vital signs will be 
recorded. A blood sample (approximately 13 mL) for hematology (including platelet count) 
and chemistry panels (see list of specific parameters in Table 9) will be taken; hematology and 
chemistry panels do not need to be repeated if screening assessments were performed within 
7 days prior to apheresis. Subjects will be asked about concomitant medications, nicotine 
and/or cannabis use, and updates to baseline medical history. 
5.3.6.2 Day 0: Apheresis Collection 
Study subjects who qualify to participate in any study stage will provide one or two single or 
double apheresis platelet collections (depending upon whether it is a crossover stage) as 
described in Section 5.3.2.1. 
Subjects will be asked about AEs (serious or non-serious) that may have taken place during or 
following the collection, and these will be recorded. 
5.3.6.3 Day 0-1: Post Apheresis Collection Input Sample 
A sample (approximately 10-20 mL) will be aseptically removed from the component for 
in vitro platelet assessments (Table 11). 
5.3.6.4 Day 0-1: Platelet Pathogen Reduction with the INTERCEPT Blood System  
INTERCEPT treatment (Figure 2) will begin within 24 hours of collection (Day 0) following 
the steps outlined in Section 5.3.2.2. The INTERCEPT platelets will be weighed for 
calculation of post-treatment volume.   
Following the INTERCEPT treatment process, the individual INTERCEPT storage containers 
will be weighed for calculation of post-treatment volume. A post INTERCEPT sample will be 
removed using the integrated sample bulb (on the “Test-A” container and approximately 3 mL 
of platelet component will be withdrawn to measure the post-INTERCEPT platelet count.  The 
volume, dose and platelet yield retention will be calculated (Table 11).  

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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5.3.7 Bacterial Testing 
A sample (approximately 8 to 20 mL) of the Test platelets will be withdrawn 1, 2 or 3 days 
prior to the end of storage for bacterial contamination screening. Testing for bacterial 
contamination will utilize an approved system for aerobic culture of potential viable bacteria. 
Bacterial detection testing is not considered a licensure requirement for INTERCEPT platelet 
components treated within the first 24 hours after collection based on studies that have 
demonstrated effective inactivation of bacteria through 7 days of storage. INTERCEPT 
technology is approved to replace current bacterial detection methods. However, bacterial 
detection will be used in this study because the study subjects are healthy volunteers who will 
derive no benefit from platelet reinfusion. Bacterial detection testing will provide an extra 
measure of safety for these volunteer subjects. In addition, in the event that any subject 
experiences a post transfusion febrile reaction, the bacterial detection samples will be useful to 
evaluate the cause of the febrile reaction. 
5.3.8 Platelet Storage: Stage 1 Days 1-7; Stage 2 Days 1-7 
All INTERCEPT platelets will be stored under standard conditions of continuous agitation 
with approved devices and temperature control (20°C to 24°C) until the end of Day 7 post- 
collection for each stage.  
5.3.9 Platelet Radiolabeling and Infusion, Day 7 (0 DPI) 
5.3.9.1 Subject Procedures Prior to Infusion 
On the scheduled infusion day (0 DPI or Day 7 of component storage), subjects will return to 
the laboratory. Subject’s weight and vital signs, urine or blood pregnancy test (if applicable 
subject is female), and a blood sample (approximately 13 mL) for hematology and chemistry 
panels (see list of specific parameters in Table 9) will be taken. Subjects will be asked about 
concomitant medications, nicotine and/or cannabis use and AEs (serious or non-serious) that 
may have taken place.  
5.3.9.2 Collection of Fresh Platelets (Control) 
On the day of scheduled infusion, 43 (±2) mL of the subject’s blood will be drawn into a 
syringe containing 9 mL of ACD-A for preparation of the Control PRP platelets. In addition, 
approximately 10 mL of the subject’s blood will be collected in an EDTA tube to determine 
the elution for each radiolabel using the BEST version 4.2.1 method (Appendix B).  
Fresh platelets will be prepared from the 43 (±2) mL sample according to the following 
procedure: Collect 43 (±2) mL of whole blood into a syringe containing 9 mL of ACD-A and 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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transfer into two 50 mL conical screw-top tubes and rest for 30 minutes (alternatively, 43 mL 
of whole blood can be collected with 7 mL of ACD-A followed by a 1-2 h holding period).   
The tubes will be centrifuged at 200 × g for 15 minutes to prepare platelet-rich plasma (PRP), 
and the PRP from each tube will be transferred to another conical tube. ACD-A equal to 15% 
of the PRP volume will be added. Prior to radiolabeling the Control platelet sample will be 
evaluated as described in Section 8.2.1. 
5.3.9.3 Release criteria of Test platelets 
At the end of storage (Day 7), prior to radiolabeling, Test platelet sample must fulfill the 
release criteria, as detailed in Table 8. Test components that do not fulfill the release criteria, 
will not be radiolabeled or transfused and hence will not be included in the primary efficacy 
analysis for the platelet recovery and survival. 
Table 8 
Release Criteria on Day of Radiolabeling/Infusion 
Attribute 
Method 
Specification 
Description 
Visual Inspection 
Semi-opaque liquid in plastic 
container 
Labeling 
Visual Inspection 
Affixed and completed 
Product integrity 
Visual Inspection 
No evidence of clots, fibrin strands, 
aggregates, or compromised container 
integrity 
Bacterial contamination 
BacT/ALERT 
Negative to date 
Records review 
Data capture sheets 
Complete and reviewed 
5.3.9.4 Preparation of Test Platelets for radiolabeling– Test Platelets Stored for 7 Days 
On the day of scheduled radiolabeling and infusion (Day 7 post-apheresis), two matched 
samples of 10-30 mL will be aseptically removed from the “Test-A” container for 
radiolabeling.  For Test platelets stored in one container, the sample for radiolabeling will be 
removed before the unit is sampled for in vitro platelet function testing. The final storage 
containers will be weighed to determine platelet component volume after sampling. 
The Test platelets are prepared for radiolabeling using either the BEST version 4.2.1 method 
(Stage 1; Appendix B) or the Variant 1 method (Stage 1 and Stage 2; Appendix C) and 
protocol specific modifications listed in Table 15 and Table 16, respectively.  Prior to 
processing and immediately before radiolabeling the Test platelet samples will be evaluated as 
described in Section 8.2.1. 
Percentage process recovery prior to the radiolabeling procedure will be calculated from the 
pre and post processing platelet counts and sample volumes for Test platelets.

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
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5.3.9.5 Test and Control Platelet Radiolabeling 
Previously stored Test platelets and fresh PRP Control platelets will be radiolabeled according 
to randomization assignment for that subject with either 51Cr as sodium radiochromate 
(Na251CrO4), or 111In as indium oxine, following the labeling and washing procedures outlined 
in the BEST version 4.2.1 procedure (Appendix B) or the Variant 1 procedure (Appendix C), 
dependent upon Stage and where applicable, randomization. The isotope labels will be 
determined by a random number table such that equal numbers of fresh platelets (Control) and 
stored Test platelets will be labeled with each isotope.  
For both Control and Test platelets, after resuspension in a small volume of ACD-A/saline, 
either 50–100 μCi 51Cr or 50–60 μCi of 111In is added to the platelets and incubated for 20 +2 
minutes at room temperature to achieve radioactive labeling. The platelets are washed to 
remove excess radioactivity and then resuspended in autologous platelet-poor plasma.  
5.3.9.5.1 Radiolabeling Efficiency 
Efficiency of labeling will be measured for each radioactive isotope according to the 
BEST version 4.2.1 procedure (Appendix B) or Variant 1 procedure (Appendix C), as 
applicable.  
5.3.9.5.2 Elution of Radioactivity from Labeled Platelets  
Radiolabel spontaneously dissociates (elution) from platelets both in vitro and in vivo 
(Holme, et al. 1993, Snyder, et al. 2004). To correct for elution before calculation of recovery 
and survival, the mean elution of radioisotope into the plasma after radiolabeling will be 
measured in vitro and modeled using an assay to estimate in vivo elution using the BEST 
elution assessment method (BEST version 4.2.1 method, Appendix B). 
5.3.9.6 Stored Test Platelet In Vitro Function Testing 
An aliquot (10-20 mL) of the stored Test platelets will be aseptically removed from the 
subject’s test container on the scheduled day of infusion; pH and in vitro platelet function 
assessments will be performed (Table 11).  
For Test components stored in one container, remove the sample for radiolabeling before the 
unit is sampled for in vitro platelet function testing. For platelets stored in two containers, the 
samples for pH assessment and for radiolabeling will be removed from “Test-A” container and 
sample for the in vitro platelet function testing will be removed from the “Test-B” container.  

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
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5.3.9.7 Retention of Test Platelet Component 
Once all of the end of storage sampling is complete, the Test components will be placed in 
refrigerated storage and reserved for future bacterial culture in the event of a febrile 
transfusion reaction indicative of sepsis (temperature elevation >2°C from pre-infusion or 
greater than 1°C with rigors).  Three days post infusion, the Test components will be discarded 
following institutional practices.   
5.3.9.8 Infusion of Test and Control Aliquots and Post-Infusion Subject Procedures  
After radiolabeling, and a negative pregnancy test (if subject is female), the autologous fresh 
PRP Control platelets and stored radiolabeled INTERCEPT platelets (Test) will be combined 
and infused into the subject (approximately 10-30 mL). Subject weight and vital signs will be 
measured prior to infusion and a sample will be obtained from the combined radiolabeled fresh 
and stored platelets before infusion and used as a radioactive standard. 
Blood samples (approximately 10 mL) will be drawn from the subject pre-infusion and for 
radioactivity measurements at 1 hour ± 15 min and 2 hours ± 15 min from the end of infusion. 
For details on radioactivity measurements, see Section 8.2.2. 
At each blood sampling time, subject vital signs, concomitant medications, AEs and SAEs will 
be recorded, and when completed, the subject will be discharged. 
5.3.10 Subject Procedures: 1 – 7 DPI 
On days corresponding to 1, 2, 3, 4 (or 5 or 6), and 7 (or 8) DPI in each stage and study period, 
subjects will return to the research unit at approximately the same time of the radiolabeled 
platelet infusion (within 4 hours). Blood samples (10 mL) will be drawn to measure 
radioactivity. An additional 2-4 mL will be collected on 1 and 4 (5 or 6) DPI to characterize 
RBC contamination (study Stage 1 only). The exact times of sampling will be recorded. Vital 
signs will be recorded, and subjects will be questioned about concomitant medications, and 
nicotine and/or cannabis use and AEs/SAEs.  
5.3.11 Subject Procedures – End of Study 
On the day corresponding to 11±1 days post-infusion in each stage and each study period, 
where applicable, subjects will return to the research unit at approximately the same time of 
the radiolabeled platelet infusion (within 4 hours). Blood samples (25-27 mL) to measure 
radioactivity and to characterize RBC contamination will be drawn as well as for hematology 
and chemistry panels (see list of specific parameters in Table 9). The exact time of sampling 
will be recorded. Subjects will undergo a physical examination, vital signs and weight will be 
recorded, and subjects will be questioned about concomitant medications, and nicotine and/or 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
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cannabis use and AEs/SAEs. A pregnancy test will be done for females. Adverse events 
occurring within 24 hours after the last blood draw will be recorded. 
5.3.12 Study Procedure Definitions 
The following list is a description of the procedures to be completed during the study:
5.3.12.1 Informed Consent 
An institutional review board (IRB) approved informed consent must be signed and dated by 
each study subject prior to any study procedures being performed, and a copy must be given to 
the subject.  
5.3.12.2 Inclusion and Exclusion Criteria Assessment 
Each study stage will enroll separate cohorts of study subjects. All subjects must qualify for 
any study stage based on the inclusion and exclusion criteria specified in Section 6.1 and 
Section 6.2, respectively.  
5.3.12.3 Medical History, Demographics, and Prior Medications 
A complete medical history will be obtained including a review of all major organ systems. 
The medical history, demographics, a list of prior medications (including drugs of abuse) and 
history of nicotine and/or cannabis use will be taken at screening. Demographics will include 
gender, date of birth or age at time of screening, race, and ethnicity. Prior medications will 
include all medications taken for 4 weeks prior to screening, including oral contraceptives.  In 
addition, a brief medical history, and a review of concomitant medications including drugs of 
abuse, and nicotine and/or cannabis use will be performed on Day 0 of both study stages.   
5.3.12.4 Physical Examination 
A physical examination will be performed at screening and on the final day of each study stage 
and study period, where applicable, or upon early termination. The examination will include 
all major body systems with the exception of genitourinary. Personnel performing the physical 
exams must be qualified by training and state licensure. 
5.3.12.5 Vital signs 
Vital signs will be obtained for each study stage at screening, and for each study stage or 
period, as applicable, on Day 0 (prior to the apheresis collection), on 0 DPI, the day of 
scheduled infusion, (pre-infusion and at 1 hour ± 15 min and 2 hours ± 15 min post-infusion), 
and on all follow up days, or upon early withdrawal. Study vital signs will include 
temperature, sitting blood pressure (to be taken after 5 minutes of sitting), and heart rate. 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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5.3.12.6 Weight, Height, and Body Mass Index 
Subjects will be weighed in street clothes after removing shoes and coat or jacket. Subject 
height will be measured without shoes. Weight will be measured for each study stage at 
screening, and for each study stage or period, as applicable, on Day 0 (prior to apheresis 
collection), prior to infusion of radiolabeled platelets (Day 7), and at the end of study, or upon 
early termination. Height will be measured at screening only. Subjects will have their body 
mass index (BMI) calculated at screening using the following formula: BMI (kg/m2) = weight 
(kg)/height (m2). Blood volume will be calculated using the method in the BEST Platelet 
Radiolabeling Procedure version 4.2.1 (Appendix B).
5.3.12.7 Blood Sampling 
5.3.12.7.1 
Stage 1 
Subject blood samples will be collected at each time indicated in the Schedule of Assessments 
(Table 7). The date and time of sample collection, as well as the date and time of dose 
administration, will be recorded. Up to approximately 24 mL of blood will be collected for 
blood donor screening and viral screening.  Up to approximately 13 mL of blood will be 
collected at each of the protocol-specified time points for hematology and chemistry panels. 
Approximately 10 mL for radioactivity measurements will be collected at each of the protocol-
required time points 0, 1 hour ± 15 min, 2 hours± 15 min and 2, 3, and 7 (or 8) DPI. Up to 
approximately 12-14 mL for radioactivity measurements and RBC contamination assessment 
will be collected at each of the protocol-required time points 1, 4 (or 5 or 6), and 11 DPI. In 
addition, blood samples will be collected to prepare Control platelets (approximately 43 mL) 
and the radiolabeling elution assessments (up to 10 mL). A total of approximately 231 mL of 
subject blood will be obtained during each study period for screening, hematology, chemistry, 
and radioactivity measurements; for Stage 1, the total will be approximately 462 mL  
5.3.12.7.2 
Stage 2  
Subject blood samples will be collected at each time indicated in the Schedule of Assessments 
(Table 7). The date and time of sample collection, as well as the date and time of dose 
administration, will be recorded. Up to approximately 24 mL will be collected for blood donor 
screening and viral screening.  Up to approximately 13 mL will be collected at each of the 
protocol-specified time points for hematology and chemistry panels. Approximately 10 mL 
will be collected for the radioactivity measurements at each of the protocol-required time 
points. An additional approximately 2-4 mL will be collected for the RBC contamination 
assessment at the protocol required time point 11± 1 DPI. In addition, blood samples will be 
collected to prepare Control platelets (approximately 43 mL) and the radiolabeling elution 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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assessments (up to 10 mL). A total of approximately 223 mL of subject blood will be obtained 
during study Stage 2 for screening, hematology, chemistry, and radioactivity measurements.  
5.3.12.8 Laboratory Tests 
The local laboratory will perform the subject hematology and chemistry panel tests specified 
in Table 9.  
Table 9 
Subject Clinical Laboratory Tests 
Hematology 
Serum Chemistry 
Hematocrit 
Hemoglobin 
Red Blood Cell Count 
Platelet Count 
White Blood Cell Count (with 
Differential) 
Blood Urea Nitrogen 
Calcium 
Carbon Dioxide 
Chloride 
Creatinine 
Glucose 
Potassium 
Sodium 
 
Samples (approximately 13 mL) for clinical laboratory tests will be taken at screening for all 
stages, Day 0 of each collection (not required if Stage specific screening clinical laboratory 
tests were performed within 7 days of collection), at the end of the storage/day of scheduled 
infusion (one or two study periods, depending upon stage), and at the last scheduled blood 
draw (11± 1 DPI), or upon early termination. 
All samples will be collected in accordance with acceptable laboratory procedures and 
processed according to the local laboratory standard procedures. Copies of the laboratory 
certificates and procedure, or reference to the procedure, will be filed in the study records. 
Laboratory values that are out of range will be identified and may be repeated at the 
Investigator's discretion after notification of the sponsor. The Investigator will determine if any 
out of range laboratory values are clinically significant and will record these on the AE case 
report form (CRF). The Investigator may refer the subject for medical treatment, as 
appropriate, until this occurs. 
5.3.12.9 Radioactivity Measurements 
See Section 8.2.2.  
5.3.12.10 In Vitro Platelet Function Testing 
See Section 8.2.3, Table 11.  

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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5.3.12.11 Pregnancy Test 
A urine or blood pregnancy test will be performed on all female subjects of childbearing 
potential at screening for all stages, and for each study period, on all female subjects prior to 
infusion and on the last day of the study period, or upon early termination. 
5.3.12.12 Drug Screening Test 
A urine drug screening test will be performed on all subjects during screening in both stages, 
including both periods 1 and 2 in Stage 1.  
5.4 
Accountability of Investigational Product  
The investigational platelet products will be produced by each participating blood center 
according to instructions for use or as specified by the protocol.  Investigational product 
accountability of the INTERCEPT for Platelets Dual Storage sets, apheresis collection 
products and the whole blood collection products will be maintained by the Investigator or 
designee. 
5.4.1 Handling and Disposal 
The investigational product produced at the site will be handled and disposed of according to 
the site’s SOP. 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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6.0 
SELECTION AND WITHDRAWAL OF SUBJECTS 
The study population consists of healthy volunteer subjects who meet the FDA, AABB and 
institutional eligibility criteria for autologous apheresis platelet donation and the study 
inclusion/exclusion criteria detailed below. In each study stage, subjects who do not have both 
paired (Test and Control) recovery and paired survival data may be replaced, and a sufficient 
number of subjects will be enrolled to provide up to 12 (Stage 1) and 24 (Stage 2) subjects 
with evaluable in vivo recovery and survival data. 
6.1 
Subject Inclusion Criteria 
• Age ≥18 years, of either gender 
• Normal health status (as determined by the Investigator review of medical history and 
blood donor physical exam) 
• Meet FDA, AABB and site specific guidelines for blood donation and apheresis 
platelet donation; travel, tattoos/piercings and/or male to male sexual contact deferrals 
do not apply 
• Complete blood count (CBC) and serum chemistry values within normal limits or 
within guidelines, as above 
• Pre-donation platelet count of more than 150×109 platelets/ L 
• Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, syphilis, and 
WNV (during screening) 
• Subjects of childbearing potential must agree to use a medically acceptable method of 
contraception throughout the study. A barrier method of contraception must be 
included, regardless of other methods.  
• Signed and dated informed consent form 
6.2 
Subject Exclusion Criteria 
• For participation in Stage 2, received any previous infusion in this study. 
• Clinically significant acute or chronic disease (as determined by the Investigator).  
• Pregnant or nursing females 
• Subjects of childbearing potential not using effective contraception 
• Disease states or conditions that preclude apheresis platelet donation per AABB 
reference standards 

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• Subject received platelet inhibitor within 14 days of donation (e.g., clopidogrel, 
ticlopidine, amphetamines (e.g., Adderall, Dexedrine)). 
• Subjects with positive cocaine and/or amphetamine results from urine drug screen.  
• Treatment with aspirin or aspirin-containing medications within 7 days of apheresis or 
treatment with non-steroidal anti-inflammatory drugs (NSAID), anti-platelet agents or 
other drugs affecting platelet viability within 3 days of apheresis (e.g. ibuprofen or 
other NSAIDs) 
• Splenectomized subjects 
• History of known hypersensitivity to indium or chromium 
• Receipt of an investigational product within the past 28 days  
6.3 
Subject Withdrawal Criteria 
Subjects may withdraw from the study at any time. The Investigator may remove a subject for 
reasons of safety or non-compliance.  
The Investigator must determine the primary reason for withdrawal and record it on the CRF. 
The Investigator or the Medical Monitor may exercise his/her medical judgment to terminate a 
subject’s participation in the study due to clinically significant changes in any clinical or 
laboratory parameters. The study sponsor also reserves the right to terminate the study at any 
time. All data normally collected at completion of the study must be collected either at the 
time of the subject’s withdrawal, or before or during the scheduled study close-out. The 
Investigator will indicate if the withdrawal is associated with indirect or direct COVID-19 
related circumstances.  
The primary reason for withdrawal should be noted in the CRF using the following categories: 
• Adverse Event: The subject has experienced an AE that, in the opinion of the subject or 
Investigator, requires early termination (withdrawal). The Investigator must complete 
an AE CRF for each AE. If a subject is withdrawn from the study due to an AE, the 
Investigator is required to follow the subject until the event is resolved or it becomes 
stable.  
• Significant Protocol Deviation: The subject failed to adhere to protocol requirements. 
• Withdrawal of Consent: The subject (or other responsible individual) wishes to 
withdraw from the study for non-medical reasons, as determined by the Investigator. 
• Death 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
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• Investigator Discretion:  In the Investigator’s judgment, it is in the subject’s best 
interest to be withdrawn from the study. 
• Study Termination: The Sponsor, IRB, or FDA terminates the study. 
• Lost to Follow-Up 
6.4 
Stopping Rules 
There are no pre-specified stopping rules for this study. The Sponsor may stop the study for 
any reason. 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
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7.0 
TREATMENT OF SUBJECTS 
7.1 
Treatments 
In each study stage, and in each study period of Stage 1, each subject will provide one 
apheresis platelet component and receive one infusion of autologous radiolabeled fresh 
Control platelets combined with Test platelets stored for 7 days (approximately 10-30 mL). 
Platelets are administered by intravenous infusion in a peripheral vein via a 19-gauge butterfly 
infusion needle. 
Procedures will be as follows: On Day 0 of each study period, each healthy volunteer subject 
provides a single or double apheresis platelet collection.  
On Day 7 (0 DPI), subjects will return to the laboratory, and 43(±2) mL of blood will be drawn 
into a syringe containing 9 mL of ACD-A, USP (2.13% free citrate ion) (alternatively, 43 mL 
of WB can be collected with 7 mL of ACD-A followed by a 1-2 h holding period) and held for 
30 minutes.  Fresh platelets will be prepared from this sample for radiolabeling according to 
the BEST method. Two matched aliquots (10-30 mL) of the stored autologous Test platelets 
will be aseptically removed from each subject’s platelet storage container and prepared for 
radiolabeling according to either the BEST (Stage 1) or the Variant 1 (Stage 1 and Stage 2) 
method, depending upon randomization, where applicable, and study stage. Previously stored 
(Test) and fresh platelets (Control) will be radiolabeled with either 51Cr as sodium 
radiochromate (Na251CrO4), or 111In as indium oxine, depending upon randomization order, 
following the labeling and washing procedures outlined in Appendix B (BEST method) or 
Appendix C (Variant 1). The isotope labels will be determined by a random number table 
such that equal numbers of fresh platelets and stored INTERCEPT platelets will be labeled 
with each isotope. Aliquots of the fresh Control will be radiolabeled with the BEST method 
and stored Test platelets will be radiolabeled in tubes with the BEST method (Stage 1) or the 
Variant 1 (Stage 1 and Stage 2) method, depending upon stage, and where applicable, method 
randomization. After radiolabeling, the autologous fresh and stored platelets will be 
simultaneously infused into the subject (approximately 10-30 mL). The pregnancy test for 
females is required to be negative before infusion in each period. 
Subject blood  samples for radioactivity measurements will be drawn during each period as 
follows: pre-infusion,1 ± 15 min and 2 hours post-infusion, and on Days 1, 2, 3, 4 (or 5 or 6), 7 
(or 8), and 11 ± 1 DPI (see schedule in Table 6 and Section 5.3.12.7 Blood Sampling). 

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7.1.1 Subject Confinement and Restrictions 
Subjects will visit the study site on Day 0 to have single or double apheresis platelets 
collected. On day of scheduled infusion, subjects will return to the study site, and blood 
samples will be drawn to prepare a fresh platelet sample (Control) and to test for radiolabel 
elution. Fresh and stored INTERCEPT platelets will be radiolabeled and infused to the 
subjects (autologous infusion). Subjects will have to stay in or return to the study site or 
facility where blood is being drawn until the 2 hours ± 15 min post-infusion blood sample is 
drawn. Thereafter, subjects will visit the study site on 1, 2, 3, 4 (or 5 or 6), 7 (or 8), and 11 ±1 
DPI (within 4 hours of the initial infusion time).  
Subjects will be instructed to abstain from treatment with aspirin or aspirin-containing 
medications within 7 days of apheresis or treatment with non-steroidal anti-inflammatory 
drugs (NSAID), anti-platelet agents or other drugs affecting platelet viability within 3 days of 
apheresis (e.g., ibuprofen or other NSAIDs). 
Subjects will not engage in any strenuous activity while confined to the research unit and will 
follow the rules governing their activities, as set forth by the unit.  
7.2 
Concomitant and Excluded Therapy 
Concomitant medications (including drugs of abuse) will be recorded during study 
participation. Subjects taking medications that preclude apheresis platelet donation per AABB 
reference standards and subjects with positive amphetamine and/or cocaine test results are 
excluded from participating in the study.   
Treatment with aspirin or aspirin-containing medications within 7 days of apheresis or 
treatment with non-steroidal anti-inflammatory drugs (NSAID), anti-platelet agents or other 
drugs affecting platelet viability within 3 days of apheresis (e.g., ibuprofen or other NSAIDs) 
will preclude apheresis. 
7.3 
Subject Compliance 
Healthy subjects who understand the study commitments and sign the informed consent will 
be enrolled in the study.  
Treatment compliance will be tracked by the Investigator or designee, recorded on the CRF, 
and monitored by the Sponsor. 

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8.0 
ASSESSMENT OF EFFICACY 
8.1 
Efficacy Parameters 
8.1.1 Primary Efficacy Endpoints 
For Stage 1 (BEST and Variant 1) and Stage 2: 
• Post infusion recovery of Test platelets at end of storage (Day 7)  
• Post infusion survival of Test platelets at end of storage (Day 7) 
Post-infusion platelet recovery and survival will be estimated by using radiolabeled platelets 
with a computerized multiple hit gamma function analysis with a curve fitting algorithm. 
Post-infusion blood samples will be corrected for plasma associated radioisotope and the 
spontaneous in vitro and vivo dissociation (elution) of radiolabels using the method described 
in the BEST version 4.2.1 (Appendix B).  
Recovery and survival of INTERCEPT components will be evaluated separately for platelets 
prepared for radiolabeling with the BEST and Variant 1 procedures.  Results will be compared 
as described in the statistical plan. 
8.1.2 Secondary Efficacy Endpoints 
• Product parameters at end of INTERCEPT treatment: 
o Platelet count, volume, and dose (≥3.0×1011) 
o Platelet yield retention (≥80%) 
• Test Product Parameters at the end of Storage 
o pH 22°C (≥6.2) 
8.1.3 Additional Endpoints 
Additional analyses will include the in vitro function parameters of the stored INTERCEPT 
platelet component and the platelet samples (after radiolabeling preparation process) prior to 
radiolabeling. 
• Product parameters at end of storage (Day 7): 
o Platelet count, platelet dose, and component volume. 
o Biochemical assessments: glucose, lactate, pO2, pCO2, bicarbonate, LDH, % of 
baseline adjusted lysis (LDH activity platelet concentrate supernatant at end-of-

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
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storage – Day 0 / Total LDH activity in Triton × 100 lysed platelet concentrate), 
and ATP. (Normalized O2 consumption, normalized CO2 production, normalized 
glucose consumption, normalized lactate production and normalized ATP 
production values will be calculated per platelet.) 
o Functional assessments: HSR, ESC, CD62 (p-selectin expression) MPV, 
morphology score  
• Test platelet sample parameters prior to processing and again before radiolabeling  
(Table 10). 
o Platelet count, volume (Stages 1 and 2) 
o Calculated % platelet yield (platelet recovery) during BEST or Variant 1 
procedures (Stages 1 and 2) 
o WBC count (WBC contamination) (Stage 1) 
o RBC count (RBC contamination) (Stage 1) 
o pH22°C (Stages 1 and 2) 
o CD62P (Stage 1 and 2 assessed prior to processing, and Stage 1 assessed again 
before radiolabeling) 
• RBC contamination in subject’s radiolabeled WB sample  
8.2 
Methods and Timing of Efficacy Parameters 
8.2.1 Assessment of Stored Platelet Samples Prior to Radiolabeling 
A paired sample of stored (7 day or 0 DPI) Test platelets will be assessed prior to processing 
and immediately prior to radiolabeling step (resuspended hard spin pellet) to evaluate platelet 
yield (Stages 1 and 2), RBC (Stage 1) and WBC content (Stage 1) (Table 10). 
 
 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
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Table 10 
Assessment of Test Platelet Sample Prior to Radiolabeling 
Assay 
Study Stage 
Method 
Stored Test 
Platelet 
Component 
Sample 
Processed 
Platelet Sample 
for 
Radiolabeling 
Test 
Sample volume 
1 and 2 
NA 
X 
X 
Platelet Count 
1 and 2 
Automated counter 
Xa 
X 
RBC Count 
1 
Hemocytometer or 
Flow Cytometry 
- 
X 
WBC Count 
1 
Leucocount 
- 
X 
pH 22°C 
1 and 2 
Blood Gas Analyzer 
or ion selective 
electrode 
Xa 
X 
CD62P 
1 and 2 
Flow Cytometry 
Xa 
Xb 
a 
Test platelets only will be analyzed as part of end of storage in vitro assessments outlined in Table 11.  
b 
The processed platelet sample for radiolabeling test is assessed for CD62P in Stage 1 only. 
 
Characterization of residual RBCs will be performed either by manual counting or using an 
antibody to CD235a which is expressed on erythrocytes and erythrocyte precursors and is 
associated with the MNS blood group (Reid 2009; Gahmberg, et al. 1978). 
Characterization of residual WBCs will be performed using the Leucocount Kit (Becton 
Dickenson) which uses propidium iodide that stains the nucleic acids of the DNA contained 
within the WBCs and is analyzed using flow cytometry. 
8.2.2 Radioactivity Measurements and Recovery and Survival Estimation 
Samples will be obtained from the radiolabeled Control and stored Test platelets before 
infusion and used as a radioactive standard. By measuring the volume infused, the total dose of 
radioactivity infused will be calculated. The radioactivity of the samples will be determined by 
use of a gamma counter. Sample dilutions for enumeration of radioactivity of the standards 
will be calibrated to ensure that measured values are at least 10-fold background values. 
Duplicates of the subject’s WB will be measured for radioactivity while singletons of all other 
samples will be evaluated. Post-infusion blood samples will also be corrected for plasma 
associated radioisotope and the spontaneous in vitro and vivo dissociation (elution) of 
radiolabels using the BEST elution assessment method (BEST version 4.2.1, Appendix B).  

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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8.2.3 Red Blood Cell Contamination Assessment 
Post infusion blood samples will be also used to determine the level of RBC/WBC 
contamination in the radioactivity measurements.  Ficoll gradient centrifugation of the WB 
sample will allow for separation of the RBCs and some WBCs from the plasma, WBC and 
platelets. The radioactivity associated with the RBC and non-RBC associated fractions will be 
measured. RBC contamination will be determined on 1, 4 (or 5 or 6) and 11±1 DPI in Stage 1 
and only on 11±1 DPI in Stage 2.  
8.2.4 In Vitro Platelet Assessments 
Samples for analysis of pH need to be analyzed shortly after preparation. The remaining 
indices listed in Table 11 should be tested or prepared for testing following site SOPs. 
Samples for assessment of ATP will be prepared by the site and sent to a centralized lab for 
analysis.  Samples for assessment of CD62P, LDH, glucose, morphology (if fixed) and lactate 
can be prepared and stored for analysis at a later date per site specific SOPs.   
Table 11 
In Vitro Platelet Function Assays to Evaluate INTERCEPT Platelet 
Components 
Assay 
Pre 
INTERCEPT 
Day 0-1 
Post 
INTERCEPT 
End of Storage 
Component weight (g) 
X 
X 
X 
Platelet count (×103/µL) 
X 
X 
X 
Platelet dose (×1011 cells/unit) a 
X 
X 
X 
Mean platelet volume (MPV) (fL) 
- 
- 
X 
Morphology score (max 400) 
- 
- 
X 
pH22°C 
X 
- 
X 
pO2 (37°C) (mm Hg)c 
- 
- 
X 
pCO2 (37°C) (mm Hg)c 
- 
- 
X 
HCO3− (37°C) (mmol/L)c 
- 
- 
X 
Supernatant glucose (mmol/L)c 
- 
- 
X 
Supernatant lactate (mmol/L)c 
- 
- 
X 
Supernatant LDH (U/L)c 
X 
- 
X 
Total LDH (U/L) 
X 
- 
X 
ATP (µmol/dL)c 
X 
- 
X 
Extent of Shape Change (%) 
(ESC) 
- 
- 
X 
Hypotonic Shock Response (%) 
(HSR) 
- 
- 
X 
CD62P (% P-selectin expression)  
X 
- 
X 

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Assay 
Pre 
INTERCEPT 
Day 0-1 
Post 
INTERCEPT 
End of Storage 
Platelet lysis (%)b 
X 
- 
X 
Bacterial culture 
- 
1-3 days before 
end of storage 
- 
a 
Platelet dose is calculated from the platelet count and volume. 
b 
Calculated from ratio of LDH activity in 1 mL of platelet concentrate supernatant to the total LDH activity in 1 mL of 
Triton X-100 lysed platelet concentrate. 
c 
The values for these parameters will also be normalized for platelet count. 
 
Specific assays and equipment for the assessment of the in vitro parameters will be detailed in 
the study manual and the clinical study report. 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
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9.0 
ASSESSMENT OF SAFETY 
9.1 
Safety Parameters 
9.1.1 Safety Endpoints 
• Adverse events 
• Vital signs 
• Hematological profile 
• Serum chemistry profile 
9.2 
Methods and Timing of Safety Parameters 
Subjects will be actively monitored for AEs during apheresis collection and during the 
radiolabeled platelet infusion, until they are discharged from the study site. After discharge 
from the study site, all AEs reported by the subject to the study staff will be recorded on the 
CRF. AE and SAE data may be collected by phone or in person by study staff.  
Vital signs are collected for all stages at screening, and for each study period prior to apheresis 
collection (Day 0), on the day of infusion (pre-infusion, and approximately 1 and 2 hours post-
infusion), and on 1, 2, 3, 4 (or 5 or 6), 7 (or 8) and 11 ± 1 DPI. Clinically significant changes 
in vital signs as assessed by the study investigator will be recorded as AEs.   
Blood samples for hematology and chemistry panels will be obtained from each subject at 
screening, and for each study period, prior to apheresis platelet collection (Day 0), prior to 
platelet infusion, and at the last scheduled blood draw (11±1 DPI). Clinically significant 
laboratory findings will be recorded as AEs. The subject laboratory assessments are identified 
in Table 9.  
9.3 
Recording and Reporting Adverse Events 
The Investigator records and assesses all AE/SAEs that occur following the start of the 
apheresis collection through 24 hours after the last DPI blood sample is drawn. All AE/SAEs 
are recorded on the CRF. 
9.3.1 Definition of Adverse Event 
An AE is any untoward medical occurrence in a subject or clinical investigation subject 
administered an investigational product and which does not necessarily have a causal 
relationship with this treatment. An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom, or disease temporally associated with 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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the use of an investigational product whether or not related to the investigational product 
(ICH E2A II/A/1, 21 CFR 312.32). 
9.3.2 Definition of Serious Adverse Event  
A SAE is any untoward medical occurrence that at any dose results in any of the following 
outcomes: 
• Death  
• Life-threatening event (results in an immediate risk of death from the reaction as it 
occurred) 
• Hospitalization or prolongation of existing hospitalization  
• A persistent or significant disability/incapacity 
• A congenital anomaly/birth defect 
• Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical 
judgement, they may jeopardize the subject and/or the subject may require intervention 
to prevent one of the outcomes listed in this definition.  
9.3.3 Definition of Unanticipated Adverse Device Effects 
Any serious adverse effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device, if that effect, problem, or death was not previously identified 
in nature, severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated with 
a device that relates to the rights, safety, or welfare of subjects. 
9.3.4 Assessing Relationship of the Adverse Event to the Study Procedure 
The Investigator is required to assess whether there is a reasonable possibility that the study 
procedures (apheresis platelet collection and/or study infusion) caused or contributed to an AE, 
per Table 12. Determination of whether there is a reasonable possibility that the study 
apheresis platelet collection or the infusion of radiolabeled study platelets caused or 
contributed to an adverse event includes assessing temporal relationships, biologic plausibility, 
dechallenge/rechallenge information (if available), association (or lack of association) with 
underlying disease, and presence (or absence) of a more likely cause.   
 

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Table 12 
Causality Assessment Scale 
Imputability Level 
Explanation 
0 
Excluded 
When there is conclusive evidence beyond reasonable doubt for 
attributing the adverse reaction to alternative causes. 
Unlikely 
When the evidence is clearly in favor of attributing the adverse reaction to 
causes other than apheresis platelet collection or the infusion of 
radiolabeled study platelets. 
1 
Possible 
When the evidence is indeterminate for attributing adverse reaction either 
to apheresis platelet collection or the infusion of radiolabeled study 
platelets to alternative causes. 
2 
Likely/ 
Probable 
When the evidence is clearly in favor of attributing the adverse reaction to 
apheresis platelet collection or the infusion of radiolabeled study platelets. 
3 
Certain 
When there is conclusive evidence beyond reasonable doubt for 
attributing the adverse reaction to apheresis platelet collection or the 
infusion of radiolabeled study platelets. 
 
9.3.5 Assessing Severity of Adverse Event 
The severity (intensity) of each AE is assessed using the standard severity grading scale 
provided in Table 13.   
Table 13 
Severity Grading Scale 
Grade 
Definition 
Grade 1 
Mild: the recipient required no medical intervention.  
Grade 2 
Moderate: the recipient may have required medical intervention (e.g. symptomatic 
treatment) but lack of such would not result in permanent damage or impairment of a 
bodily function   
Grade 3 
Severe: signs and symptoms requiring inpatient hospitalization or prolongation of 
hospitalization directly attributable to the event; and/or the event results in persistent 
or significant disability or incapacity; or the event necessitated medical or surgical 
intervention to preclude permanent damage or impairment of a bodily function.   
Grade 4 
Imminently life-threatening: unstable vital signs with major treatment intervention 
required to prevent death (e.g. vasopressors, intubation, transfer to intensive care). 
Grade 5 
Death: adverse event resulting in death following the implicated apheresis platelet 
collection or transfusion. 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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9.3.6 Assessing Seriousness of an Adverse Event 
The Investigator is required to assess if an AE resulted in any of the following outcomes that 
result in classification of the event as SAE: death, a life-threatening event (results in an 
immediate risk of death from the reaction as it occurred), inpatient hospitalization or 
prolongation of existing hospitalization, a persistent or significant disability/incapacity, a 
congenital anomaly/birth defect, or another important medical event (listed in Section 9.3.2).  
9.3.7 Reporting Adverse Events  
All AEs that occur during or after the start of any study apheresis platelet collection or are 
reported by the subject through the end of the study are recorded on the CRF. In addition, 
SAEs are recorded on the CRF and reported to the Sponsor. The Sponsor contact information 
is provided in Table 14.  
Table 14 
Sponsor Contact Information 
Name Title 
Phone 
E-mail 
Cerus Product Safety Team 
Office: +1 925-288-6014  
ProductSafetyOps@cerus.com 
Tanya O’Neal, MD  
Sr. Director, Clinical Development & 
Product Safety 
Medical Monitor 
Office: +1 925-288-6198 
toneal@cerus.com 
Richard Benjamin, MD, PhD, FRCPath 
Chief Medical Officer (Backup Medical 
Monitor) 
Office: +1 925 288-6020 
rbenjamin@cerus.com 
9.3.7.1 Reporting Serious Adverse Events 
When an SAE occurs, the Investigator records the data in the CRF (within 24 hours) and 
notifies the Cerus Product Safety Manager immediately (within 24 hours). Sponsor contact 
information is provided in Table 14.  
9.4 
Adverse Event Follow up 
The Sponsor reviews each SAE. The Sponsor may request additional appropriate follow-up 
medical information in order to write a comprehensive narrative. 
The Investigators agree to promptly provide follow-up information requested by the Sponsor. 
All SAEs are followed until resolution or the Investigator judges the event to be chronic or 
stable.  

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10.0 
STATISTICS 
10.1 
Analysis Sets 
The analysis sets will be defined as follows: 
Safety Analysis Set: 
All randomized subjects who successfully initiate an apheresis collection. 
Evaluable Analysis Set (EAS): 
All randomized and infused subjects who have both paired (Test and Control) recovery 
and paired survival data for the relevant study stage and/or radiolabeling method, and 
otherwise complied with the protocol without any other major protocol deviation.   
Summaries for the efficacy endpoints will be presented using EAS. All other summaries will 
be presented using the safety analysis set unless stated otherwise. 
10.2 
 Statistical Methods  
This study utilizes a paired design to characterize the recovery and survival of autologous 
apheresis INTERCEPT Test platelet components stored for 7 days compared to their untreated 
“fresh” Control platelet components.  
In addition, the study is designed to evaluate two different approaches (BEST and Variant 1 
for Stage 1, and Variant 1 for Stage 2) to radiolabeling stored INTERCEPT platelets for 
evaluation of recovery and survival. Recovery and survival of INTERCEPT Test platelets will 
be evaluated separately for each radiolabeling method. 
Data will be summarized descriptively by mean, standard deviation, median, and range 
(minimum, maximum) for continuous parameters and by frequencies and percentages for 
categorical data variables. Summaries will be presented by radiolabeling method across all 
study sites and within each study site. 
Data will be compared between the two radiolabeling methods in Stage 1.  Correlations 
between the primary and secondary efficacy endpoints may also be explored using graphs 
and/or regression analysis. 

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of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
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10.2.1 Efficacy Analyses 
10.2.1.1 Primary Endpoints  
Primary efficacy endpoints are the post infusion recovery and survival of Test platelets at end 
of storage for both Stage 1 and Stage 2.  Post-infusion recovery and survival of platelets will 
be calculated based on the corrected radioactive counts observed from the six post-infusion 
sampling time points at 1, 2, 3, 4 (or 5 or 6), 7 (or 8), and 11 ± 1 days post infusion. The 
following acceptance criteria for recovery and survival will be used to demonstrate 
non-inferiority of stored Test platelets against fresh Control platelets at the end of Stage 2:  
1. 
Post-infusion recovery: 
 
H0: Test - 0.66×Control <0 vs. H1: Test - 0.66×Control ≥0 
The null hypothesis of inferiority will be rejected in favor of the alternative hypothesis of non-
inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI 
for the mean treatment difference (Test - 0.66×Control) is greater than or equal to zero.  For 
any platelet recovery values that are more than 100%, they will be capped at 100% for the data 
analysis. 
2. 
For survival: 
 
H0: Test - 0.58×Control <0 vs. H1: Test - 0.58×Control ≥0 
The null hypothesis of inferiority will be rejected in favor of the alternative hypothesis of non-
inferiority at the two-sided 0.05 significance level if the lower bound a two-sided 95% CI for 
the mean treatment difference (Test - 0.58×Control) is greater than or equal to zero. 
The two-sided 95% CI will be constructed using the variance estimated from a paired t test. 
The above acceptance criteria will also be explored for Stage 1 separately for each 
radiolabeling method that is evaluated (BEST or Variant 1).   
The primary analysis population for the primary efficacy endpoints will only include subjects 
who have both paired (Test and Control) recovery and paired survival data for the relevant 
radiolabeling method. Subjects who do not have both paired recovery and paired survival data 
may be replaced to ensure sufficient number of subjects is reached for the primary analysis. 
Reasons for absence of primary endpoint measurement(s) for any subject will be listed in the 
study report.   
In the event that non-inferiority cannot be declared for the primary endpoints with a minimum 
of 24 evaluable subjects, additional exploratory analyses may be conducted to quantify the 
proportions of subjects whose recovery and survival data meet the 0.66 and 0.58 cutoff, 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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respectively (e.g., platelet recovery from a Test PC greater than or equal to 66% of platelet 
recover from the paired fresh control).   
10.2.1.2 Secondary Endpoints 
Data will be summarized descriptively for each stage.  The proportions of Test platelet 
components with platelet dose ≥ 3.0 ×1011 (end of INTERCEPT treatment), physical platelet 
recovery ≥80% (end of INTERCEPT treatment), and pH22°C ≥6.2 (end of storage) will be 
summarized, with the corresponding lower bound of a one-sided 95% CI for the proportion 
provided.  
10.2.2 Additional Endpoints 
10.2.2.1 In Vitro Evaluation of Stored INTERCEPT Platelet Components 
In vitro parameters of stored Test platelet components at the end of storage will be 
summarized descriptively for each study stage. 
10.2.2.2 In Vitro Evaluation of Processed Platelet Samples for Radiolabeling 
In vitro assessment of processed platelet samples will be summarized descriptively by 
treatment group (Test vs. Control), sample preparation method (BEST vs. Variant 1), and 
radiolabeling (51Cr  vs. 111In) as applicable.  Additionally, the proportions of Test platelet 
samples prior to radiolabeling with pH22°C ≥6.2 and physical platelet recovery ≥80% will be 
summarized separately for the BEST and Variant 1 procedures as applicable.  
10.2.2.3 Evaluation of Red Blood Cell Contamination 
Assessment of the RBC/WBC contamination as by Ficoll gradient centrifugation will be 
summarized descriptively by day post infusion, study arm (Test and Control), sample 
preparation method (BEST vs. Variant 1), and radiolabeling (51Cr  vs. 111In).  
10.2.3 Safety Analyses 
Treatment-emergent AEs (defined as AEs with onset on or after the initiation of apheresis 
platelet collection) will be summarized descriptively.  Other safety data (e.g., vital signs, lab 
data) will be provided in the data listings. 
10.3 
Determination of Sample Size 
A sufficient number of subjects will be enrolled to provide 24 evaluable subjects with both 
paired (Test and Control) recovery and paired survival data for Stage 2.  The sample size of 24 
for Stage 2 is chosen to provide reasonable estimates of the primary efficacy endpoints. 

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of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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10.4 
Level of Significance 
Unless stated otherwise, statistical significance will be set at the two-sided 0.05 significance 
level. Note that given the nature of this study, adjustments for multiple hypothesis testing will 
not be made.  
10.5 
Criteria for Termination of the Study 
There are no pre-specified stopping rules for this study. The Sponsor may stop the study for 
any reason. 
10.6 
Procedure for Missing, Unused, and Spurious Data 
Missing data will be noted as such. Procedures for imputing data will not be undertaken.  
10.7 
Deviations from the Statistical Plan 
Any changes in the planned analyses instituted after commencement of the study will be 
documented. The reasons for the modifications and when the changes were made will also be 
documented.  
10.8 
Selection of Subjects to be Analyzed 
The primary analysis population for the primary efficacy endpoints will only include subjects 
who have both paired (Test and Control) recovery and paired survival data for the relevant 
study stage.   

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11.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
Prior to participating in the trial, the Investigator(s)/institution(s) agrees to provide direct 
access to and copies of source data/documents for collection of baseline data, study data, 
monitoring, audits, IRB review, and regulatory inspection. Protected health information on 
source documents will be redacted prior to providing copies of the document to the sponsor.  
The quality representative(s) of the Sponsor may visit a clinical facility to ensure proper 
conduct of the protocol, recording of data, and maintenance of records. 
All study-related documents and records are subject to inspection and audit by the Sponsor (or 
designee), and by the FDA, IRB or other relevant regulatory bodies.  The 
Investigator/institution guarantees access to source documents by the study Sponsor or its 
designee, the FDA, other regulatory bodies and the IRB.  If the FDA or local health authority 
should schedule an inspection, Sponsor should be advised prior to the time this inspection is to 
occur. 
The subjects’ apheresis collection records and medical records are considered source data. 
Data worksheets used during the preparation of study platelet components will be considered 
source data for processing study platelet components.  Analyzer reports or assay results from 
the laboratory will also be considered source data.  The study data will be recorded on the 
CRF. 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
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12.0 
QUALITY CONTROL AND QUALITY ASSURANCE 
Collection of accurate, consistent, and reliable data will be ensured through the use of written 
standard practices and procedures. Clinical study monitors will assure that CRFs are 
completed correctly and that complete information has been provided. The Cerus Corporation 
Department of Quality Assurance (QA) will review data collected for this trial. At the 
discretion of the Sponsor, in addition to the study monitor, a QA representative(s) of the 
Sponsor may visit a site to ensure proper conduct of the trial in terms of collection and 
recording of data and maintenance of records as appropriate for a study performed under an 
Investigational Device Exemption. 
The clinical site will be monitored routinely to ensure Good Clinical Practice (GCP) 
compliance and data quality. The CRF will be verified against the source document and any 
queries concerning the CRF will be generated and resolved/reconciled to assure data integrity.  
The clinical site may be audited by the Sponsor or Sponsor designee for quality control and 
quality assurance purposes, as specified in the Sponsor’s SOPs for GCP compliance.  The 
clinical site may also be audited by a regulatory agency. 
The study will be monitored by the Sponsor's representatives at all stages of study conduct 
from inception to completion in accordance with current GCPs. This monitoring will include 
both centralized and on-site review and source document verification of the data. Centralized 
data will include remote review of the data (data capture sheets and electronic CRFs) that are 
provided to Cerus on a regular basis.  On-site monitoring involves the visit of a monitor to the 
investigational site.  The Sponsor's monitor or representative will notify the Investigator prior 
to conducting any investigational site visit.  It is important that the Investigator and other study 
personnel are available during the monitoring visits, and that sufficient time is devoted to the 
process. The frequency of these visits will depend upon the progress of the study and will 
encompass all aspects of the study conduct (i.e. review of all study related procedures, tour of 
the facilities, inspection of equipment and appropriate records, completion of electronic CRFs, 
recruiting methods, record-keeping, protocol adherence, data collection, AE reporting, etc.). 
Frequency of on-site monitoring may also be decreased due to institutional restrictions on site 
access or research activities due to COVID-19 (FDA 2020). 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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13.0 
ETHICS 
13.1 
Ethical Conduct of the Study 
This study will be conducted in compliance with International Council on Harmonization 
(ICH) E6(R2), Good Clinical Practices (GCP), and US Regulations governing the protection 
of human subjects (21 CFR Part 50); Institutional Review Boards (21 CFR Part 56), Financial 
Disclosure by Clinical Investigators (21 CFR Part 54); FDA Guidance for Industry: Collection 
of Platelets by Automated Methods (2007); and local IRB requirements. Investigators are 
encouraged to discuss any ethical issues that arise prior to or during the conduct of the study 
with the Sponsor. 
The Protocol and Informed Consent Form will be approved by the Investigator and the 
Investigator's IRB before the study is initiated. 
13.2 
Informed Consent 
The Informed Consent process must comply with all applicable US Regulations (21 CFR Part 
50; 21 CFR Part 640), FDA Guidance for Industry: Informed Consent Recommendations for 
Source Plasma Donors Participating in Plasmapheresis and Immunization Programs (2007), 
and the Health Insurance Portability and Accountability Act (HIPAA). A statement that 
subject medical records must be available for investigations into SAEs must be included in the 
Informed Consent Form. It should also include any additional information required by local 
laws relating to institutional review. 
The risks and hazards of study participation will be explained to the potential study subjects, 
under the supervision of a qualified, licensed physician. Written informed consent and HIPAA 
authorization will be obtained from all study subjects prior to any tests or evaluations. A copy 
of the signed informed consent will be provided to each subject and will also be maintained in 
the subject’s medical record. 
13.3 
Institutional Review Board (IRB) 
This protocol will be submitted to an appropriate central or local IRB and its written 
unconditional approval obtained and submitted to Cerus or its designee before enrollment of 
the first subject. 
Cerus will supply relevant data for Investigators to submit to the IRB for the protocol’s review 
and approval. Written verification of IRB unconditional approval of the protocol and the 
subject Informed Consent Form (ICF) will be transmitted to Cerus or its designee prior to 
granting access to the CRF to study sites. This approval must refer to the study by exact 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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protocol title and number (including version), identify documents reviewed, and state the date 
of approval. 
The Investigator must promptly report to the IRB all changes in the research activity and all 
unanticipated problems involving risk to human subjects or others. This includes all SAEs that 
have resulted in an expedited safety report to the FDA (serious, unexpected AEs possibly 
related to investigational product). Concurrently, the Investigator must send the study Sponsor 
documentation of such IRB notification as presented in Section 9.4.  The Investigator must not 
make any changes in the research without IRB approval, except where necessary to eliminate 
apparent immediate hazards to human subjects. 
13.4 
Participant Recruitment 
If an Investigator chooses to advertise for subjects, whether in professional or consumer 
publications, radio, or television, all advertising must be approved by Cerus and the IRB prior 
to initiation.  
13.5 
Disclosure of data 
Individual subject medical information obtained as a result of this study is considered 
confidential, and disclosure to third parties other than those noted below is prohibited. Subject 
confidentiality will be further assured by utilizing subject identification code numbers to 
correspond to treatment data in the computer files. 
However, such medical information may be given to the subject’s personal physician, or to 
other appropriate medical personnel responsible for the subject’s welfare. 
In addition, data generated as a result of this study are to be available for inspection upon 
request by FDA or local health authority auditors, the Sponsor’s monitors, or by the IRB. 
Therefore, absolute confidentiality cannot be guaranteed. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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14.0 
DATA HANDLING AND RECORD KEEPING 
The Investigator will maintain appropriate subject records filed by each participating subject. 
Clinical information gathered during this study will be recorded on CRFs. As used in this 
protocol, the term CRF should be understood to refer to either a paper form or an electronic 
data record or both, depending on the data collection method used in this trial. 
A CRF is required and should be completed for each included subject. The completed original 
CRFs are the sole property of Cerus and should not be made available in any form to third 
parties, except for authorized representatives of Cerus or appropriate regulatory authorities, 
without written permission from Cerus. 
It is the investigator's responsibility to ensure completion and to review and approve all CRFs. 
CRFs must be signed by the investigator or by an authorized staff member. These signatures 
serve to attest that the information contained on the CRFs is true. At all times, the investigator 
has final personal responsibility for the accuracy and authenticity of all clinical and laboratory 
data entered on the CRFs. Subject source documents are maintained at the trial site. In cases 
where the source documents are the blood donation record, the information collected on the 
CRFs must match those charts.  
In some cases, the CRF may also serve as the source document. In these cases, Cerus and the 
investigator must prospectively document which items will be recorded in the source 
documents and for which items the CRF will stand as the source document. 
All raw data generated at the blood centers will be retained at the blood center.  Raw data 
generated at any external testing facility will be retained by that facility.  Cerus will receive a 
copy of all primary data. Primary data provided to Cerus and generated by Cerus will be 
retained in the Cerus Corporation archives, managed from 1220 Concord Avenue, Suite 600, 
Concord, CA 94520. 
Investigator/institution and the Sponsor shall maintain all study records required (by subpart 
21CFR 812.140) during the investigation and for a period of two years after the latter of the 
following the two dates: 1) the date on which the investigation is terminated or completed, or 
2) the date that the records are no longer required for purposes of supporting a premarket 
approval application or a notice of completion of a product development protocol. 
Investigator/institution shall not destroy any such records prior to obtaining written permission 
from Cerus. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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15.0 
PUBLICATION POLICY 
The publication policy is part of the financial contract with each Investigator. 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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16.0 
APPENDICES 
List of Appendices 
Appendix A 
Literature References 
Appendix B 
Radiolabeling Procedure for Platelets (BEST version 4.2.1) 
Appendix C 
Radiolabeling Procedure for Platelets (Variant 1 modification 
of BEST procedure) 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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without express written consent from Cerus Corporation. 
 
Literature References 
1. 
Afssaps France Annual Hemovigilance Report 2009.  
2. 
Afssaps 2010 Annual Hemovigilance Report.  
3. 
Amato M, Schennach H, Astl M, Chen CY, Lin JS, Benjamin RJ, Nussbaumer W. 
Impact of platelet pathogen inactivation on blood component utilization and patient 
safety in a large Austrian Regional Medical Centre. Vox Sang 2017;112: 47-55. 
4. 
Amsler L, Jutzi M. Haemovigilance Annual Report 2014. Bern, Switzerland: 
Swissmedic. 
5. 
ANSM 2011 Hemovigilance Activity Report. 
6. 
ANSM Rapport d’activité hémovigilance 2012  
7. 
The Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Platelet 
radiolabeling procedure. Transfusion 2006;46 Suppl:59S-66S. 
8. 
Code of Federal Regulations (CFR). 1980. Title 21, Part 50, Protection of Human 
Subjects. 
9. 
Code of Federal Regulations (CFR). 1998. Title 21, Part 54, Financial Disclosure By 
Clinical Investigators. 
10. Code of Federal Regulations (CFR). 1981. Title 21, Part 56, Institutional Review 
Boards. 
11. Code of Federal Regulations (CFR). 1973. Title 21, Part 640, Additional Standards for 
Human Blood and Blood Products. 
12. Code of Federal Regulations (CFR). 1980. Title 21, Part 812, Investigational Device 
Exemptions. 
13. Code of Federal Regulations (CFR). 2010. Title 21, Part 312.32, Investigational New 
Drug Safety Reporting. 
14. Dumont LJ, Cancelas JA et al. 2013. A randomized controlled trial evaluating recovery 
and survival of 6% dimethyl-sulfoxide-frozen autologous platelets in healthy 
volunteers. Transfusion 53(1):128-137. 
15. FDA Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet 
Substitute Products. 1999. 
16. FDA Guidance for Industry, Collection of Platelets by Automated Methods.  2007. 
17. FDA Guidance for Industry, Informed Consent Recommendations for Source Plasma 
Donors Participating in Plasmapheresis and Immunization Programs. 2007. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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18. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 
Public Health Emergency - Guidance for Industry, Investigators, and Institutional 
Review Boards. 2020. 
19. Gahmberg CG, Jokinen M, Andersson LC. Expression of the major sialoglycoprotein 
(glycophorin) on erythroid cells in human bone marrow. Blood. 1978;52:379-387. 
20. Holme S, Heaton A, et al. 1993. Concurrent elution method allows accurate evaluation 
of platelet viability of stored platelet concentrates. Br J Haematol 84: 717-723. 
21. International Conference on Harmonisation (ICH) Guidance for Industry, E6, Good 
Clinical Practice: Consolidated Guidance.  ICH May 1996 
22. International Conference on Harmonisation (ICH), E2A, Clinical Safety Data 
Management: Definitions and Standards for Expedited Reporting.   
ICH October 1994. 
23. Kleinman S, Reed W, Stassinopoulos A. 2013. A patient-oriented risk-benefit analysis 
of pathogen-inactivated blood components: application to apheresis platelets in the 
United States. Transfusion 53:1603-1618. 
24. Kunicki TJ, Tuccelli M, et al. 1975. A study of variables affecting the quality of 
platelets stored at "room temperature". Transfusion 15(5):414-21. 
25. Lötter MG, Rabe WL, et al. 1988. A computer program in compiled BASIC for the 
IBM personal computer to calculate mean platelet survival time with the multiple-hit 
and weighted mean methods. Comput Biol Med 18:305-15. 
26. Lozano, M, Knutson F, et al. 2011. A multi-centre study of therapeutic efficacy and 
safety of platelet components treated with amotosalen and ultraviolet A pathogen 
inactivation stored for 6 or 7 d prior to transfusion. Br J Haematol  
153(3):393-401. 
27. Nussbaumer W, Amato M, Schennach H, Astl M, Chen CY, Lin JS, Corash L, 
Benjamin RJ. 2017. Patient outcomes and amotosalen/UVA-treated platelet utilization 
in massively transfused patients. Vox Sang 10.1111/vox.12489. 
28. Reid ME. MNS blood group system: a review. Immunohematology. 2009;25(3):95-
101. 
29. Schmidt M, Hourfar MK, Sireis W, Pfeiffer U, Gottig S, Kempf VA, McDonald CP, 
Seifried E. Evaluation of the effectiveness of a pathogen inactivation technology 
against clinically relevant transfusion-transmitted bacterial strains. Transfusion 
2015;55: 2104-12. 
30. Snyder E, Raife T, et al. 2004. Recovery and Lifespan of 111 Indium radiolabeled 
platelets treated with pathogen inactivation using amotosalen HCl (S-59) and UVA 
light. Transfusion 44:1732-1440. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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31. Swissmedic Haemovigilance Annual Report, 2009, 2010, 2011, 2012, 2013, 2014, 
2015. 
32. Wagner J, Benjamin RJ, et al. 2015. Inactivation of bacteria in Apheresis platelets with 
pathogen reduction performed 24 h after inoculation. Vox Sang 109 (Suppl. 1):1-379 
[abstract 4D-S27-06].  
33. Wagner SJ, Benjamin RJ, Hapip CA, Kaelber NS, Turgeon AM, Skripchenko A, 
Stassinopoulos A. Investigation of bacterial inactivation in apheresis platelets with 24 
or 30 hours between inoculation and inactivation. Vox Sang 2016;111: 226-34. 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Cerus References 
1. 
CLI 00094, A Prospective, Randomized, In Vitro Study of Apheresis Platelet 
Components in 35% Plasma and 65% InterSol Prepared by Photochemical Treatment 
Compared to Untreated Platelets in 35% Plasma and 65% InterSol. Clinical Study 
Report v3.1, June 24, 2014. 
2. 
CLI 00095, A Prospective, Randomized, In Vitro Study of Apheresis Platelet 
Components in 100% Plasma Prepared with Photochemical Treatment Compared to 
Untreated Apheresis Platelets in 100% Plasma. Clinical Study Report v 1.0, March 27, 
2015. 
3. 
CLI 00099, A Controlled, In Vivo, Pilot Study to Assess the Recovery and Survival of 
Radiolabeled Autologous INTERCEPT Treated 7-day Stored Apheresis Platelet 
Components in 35% Plasma and 65% InterSol and INTERCEPT Treated 7-day Stored 
Apheresis Platelet Components in 100% Plasma. Clinical Study Report v 1.0, 
September 8, 2015. 
4. 
CLI 00116, A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In 
Vivo Study to Assess the Recovery and Lifespan of Radiolabeled Autologous 
INTERCEPT Treated Apheresis Platelet Components Suspended in Nominal 35% 
Plasma and 65% InterSol Stored for 6 or 7 Days. Clinical Study Report, June 27, 2017. 
5. 
CLI 00123, A Prospective, Randomized, In Vitro Study of Apheresis Platelet 
Components in Plasma/For Qualification of INTERCEPT Blood System for Platelets 
Modified Processing Sets.  Clinical Study Report, October 4, 2017. 
6. 
CLI 00124, A Prospective, Randomized, In Vitro Study of Apheresis Platelet 
Components in 100% Plasma for Qualification of INTERCEPT Blood System for 
Platelets Modified Processing Sets.  Clinical Study Report, October 3, 2017. 
7. 
REL-R 00556, Evaluation of Residual Red and White Blood Cells in Apheresis and 
Whole Blood-Derived Platelets after Preparation Steps Preceding Radiolabeling for 
Recovery and Survival Studies. Report, March 6, 2019 
8. 
SPC 00701-AW v3.0, INTERCEPT Blood System for Platelets – Dual Storage (DS) 
Processing Set 
9. 
VAL 00376-2, Validation of the Preparation Steps preceding the Radiolabeling of 
Apheresis Platelets in 100% Plasma for Survival and Recovery Studies, August 17, 
2017.  
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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BEST version 4.2.1 Radiolabeling Procedure 
Platelet Radiolabeling Procedure 
 
The Biomedical Excellence for Safer Transfusion (BEST) Collaborative 
 
Corresponding Author 
James P. AuBuchon, MD 
Chair, BEST Collaborative 
Department of Pathology 
Dartmouth-Hitchcock Medical Center 
One Medical Center Drive 
Lebanon, New Hampshire 03756 USA 
 
PHONE: 603-650-8693 
FAX: 603-650-4845 
EMAIL: JAMES.P.AUBUCHON@HITCHCOCK.ORG 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Introduction 
This file contains a procedure for the radiolabeling of both stored and fresh platelets 
and their autologous reinfusion for the determination of recovery and survival as published in 
the November, 2006, supplement to Transfusion. It is being made available on the BEST 
website in a downloadable format to facilitate implementation as the routine procedure in 
laboratories performing this kind of work. When referencing this procedure, please cite the 
Transfusion Supplement. 
As detailed in other manuscripts in the Supplement, this procedure was derived from 
the validated, seminal work of Andrew Heaton, Stein Holme and colleagues in Norfolk, 
Virginia, and adapted for application to Scott Murphy’s insightful approach of comparing a 
new platelet preparation to fresh platelets from the same subject. The effort of adapting the 
procedure (kindly made available by the American Red Cross) for this purpose and thoroughly 
discussing and debating its content were undertaken by the members of the Biomedical 
Excellence for Safer Transfusion (BEST) Collaborative through multiple meetings over a two-
year period. The validation of the adaptation and its application can be found reviewed in other 
papers in this Supplement. Deviations from this procedure should be accompanied by 
appropriate validation and documentation. 
Many individuals contributed substantial time and effort in developing, reviewing, and 
validating this procedure. In particular, the leadership of the authors of the other articles in this 
Supplement should be noted as well as the meticulous reviewing undertaken by Lisa Cooke, 
Louise Herschel, Jill Roger, Sherrill Slichter, and Ralph Vassallo.  
BEST welcomes receipt of comments regarding the procedure and suggestions for 
further development. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Procedure 
 
Purpose: To describe a technique for radioisotopic labeling and infusion of fresh or 
stored platelets with 111 In Oxine (111Indium) and Na251CrO4 (51Chromium). 
 
While the measurement of platelet recovery and survival can be used for a 
variety of purposes, this procedure is intended for assessment of the in vivo 
viability of platelets that have been stored and/or treated in comparison with 
fresh platelets from the same subject. 
 
This procedure includes the basic calculations for determining platelet recovery 
and survival. The recommended manner of comparing the results between 
control and test infusions is through comparison of the paired differences and 
calculation of upper confidence intervals as detailed by Dumont in this 
supplement (See 2.6.). 
 
Applicable documents: 
 
Snyder EL, Moroff G, Simon T, Heaton A, and Members of the Ad Hoc 
Platelet Radiolabeling Study Group.  Recommended methods for conducting 
radiolabeled platelet survival studies.  Transfusion 1986; 26:37-42. 
 
Panel Report, International Committee for Standardization in Hematology.  
Recommended methods for radioisotopic platelet survival studies.  Blood 1977; 
50:1137-1144. 
 
Holme S., Heaton A., Roodt J. Concurrent label method with 111In and 51Cr 
allows accurate evaluation of platelet viability of stored platelet concentrates. 
Brit J Haematol 1993;84:717-723. 
 
Nadler SB, Hidalgo JU, Bloch T. Prediction of blood volume in normal human 
adults. Surgery 1962;51:224-232. 
 
Lötter MG, Rabe WL, Van Zyl JM, et al. A computer program in compiled 
BASIC for the IBM personal computer to calculate the mean platelet survival 
time with the multiple-hit and weighted mean methods. Comput Biol Med 
1988;18:305-15. 
 
Dumont LJ. Analysis and reporting of platelet kinetic studies. Transfusion 
2005;45 (Suppl) 67S-73S. 
 
 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Equipment/Supplies/Reagents: 
 
Calibrated, temperature-controlled, variable speed, swinging bucket centrifuge 
 
Calibrated electronic balance, accurate to ± 0.0002 g. 
 
Gamma counter with 3 inch sodium chloride crystal 
 
Laminar flow hood 
 
19-21 gauge butterfly or straight needles 
 
Sterile transfer pipettes (3.2 mL draw) 
 
15 mL and 50 mL sterile conical polypropylene plastic tubes (Note: Although 
some procedural steps specify exact sizes, an alternative appropriate size may 
be substituted.) 
 
Evacuated sample tubes with EDTA (powdered or dry “lavender tops”) 
 
ACD-A: Anticoagulant Citrate Dextrose Solution - Formula A 
 
ACD-A/ Saline Solution: mix 1 part ACD-A to 7 parts sterile (0.9%) Normal 
Saline, adjusted to pH 6.5 to 6.8 with 1 N NaOH; sterilize by filtration. (Stable 
for one week when stored in refrigerator; warm to room temperature (20-24°C) 
before use.) 
 
0.22µm Sterilizing Filter Unit. 
 
111Indium Oxine in ethanol solution containing approximately 1 mCi per vial at 
the time of manufacturer’s calibration. Use within 7 d for platelet labeling. 
(Changes in ethanol/oxine ratio over time may result in changes in platelet 
function.) 
 
111Indium Oxine Labeling solution:  If not premixed, aseptically add 4.0 mL 
sterile ACD- A/saline solution to the vial of 111Indium Oxine to make 5.0 mL of 
sterile 111In-Oxine solution for labeling.  Mix well. (Stable for one week or until 
expiration of stock 111In oxine solution.) 
 
Na2 51CrO4, Chromium-51 
 
18 gauge spinal needles sterile 
 
Assorted sterile syringes and needles (Note: Although some procedural steps 
specify exact sizes, any appropriate size may be substituted.) 
 
Positive displacement pipettes for whole blood aliquots. 
 
Assorted size pipettes and tips 
 
SDS (Sodium Dodecyl Sulfate) 20%; Dissolve 20g sodium dodecyl sulfate in 
100 mL of distilled water.  (Store at room temperature for up to one year.) 
NOTE: All vessels holding platelets or plasma that will be reinfused must be properly labeled 
to definitively identify the subject. 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Preparation of Platelets for Labeling with 111Indium Oxine  
 
Preparation of freshly collected platelets 
4.1.1 Using a 19-gauge needle, collect 43 mL (± 2 mL) of venous blood into a 
60 mL sterile plastic syringe containing 9 mL of ACD-A.  Avoid a 
traumatic venipuncture at the start of blood drawing. Care should be 
taken to avoid excessive negative pressure in the syringe during draw to 
prevent activation of the platelets. (Alternatively, 43 mL of whole blood 
can be collected with 7 mL of ACD-A followed by a 1-2 h holding 
period in Step 4.1.3.) 
4.1.2 At the same time as 4.1.1, collect one 5 or 7 mL blood sample from the 
subject into an EDTA tube. Mix well. Reserve for determination of 
radiolabel elution (see Step 9.0). 
4.1.3 Using sterile technique, in a laminar flow hood, remove the needle and 
express the contents of the syringe into two sterile 50 mL screw-cap 
conical centrifuge tubes. A hold period of 30 minutes for the ACD-
A/blood mixture before further processing should be utilized.  
4.1.4 Centrifuge (soft spin) the conical tubes at 180 to 200 x g for 15 minutes 
at 20 to 24°C with the brake off to produce red cell-poor platelet–rich 
plasma (PRP).   
4.1.5 Remove the PRP from both tubes with a sterile transfer pipette or spinal 
needle and syringe and place into a single 50 mL sterile conical plastic 
centrifuge tube.  Avoid aspirating any contaminating red cells. 
4.1.6 Add a volume of sterile ACD-A equal to 15% of the volume of PRP to 
the PRP.  Cap the tube and mix gently by inversion. Continue with Step 
4.3. 
 
Preparation of aliquot from stored platelet unit 
4.2.1 Ensure unit is thoroughly mixed and platelets are completely suspended.  
4.2.2 Using sterile technique, in a laminar flow hood, gently remove 10 mL 
from the stored platelet unit using a 20 mL syringe and 16 ga needle.   
4.2.3 Remove the needle and express the contents of the syringe into a  15 mL 
screw-cap conical  labeled centrifuge tubes containing  1.5 mL sterile 
ACD-A . Cap and mix gently by inversion. 
4.2.4 Centrifuge (soft spin) the conical tubes at 180 to 200 x g for 5 minutes 
at 20 to 24°C with the brake off to produce red cell-poor platelet-rich 
plasma (PRP).   
4.2.5 Remove the PRP with a sterile transfer pipette or spinal needle and 
syringe and place into a new 15 mL sterile conical plastic centrifuge 
tube.  Avoid aspirating any contaminating red cells. Continue with Step 
4.3. 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Centrifuge (hard spin) the ACD-PRP at 1500-2000 x g for 15 minutes at 20 to 
24ºC with brake off.   
 
Remove the platelet-poor plasma (PPP) produced, as completely as possible 
and transfer to a new sterile conical tube. Spin PPP a second time (1500-2000 x 
g for 15 minutes with brake off), discard pellet and reserve supernatant PPP in a 
sterile tube for later use (Steps 4.6.2 and 4.6.5). 
 
Using a sterile pipet, resuspend the harvested platelet pellet with 2 mL of ACD-
A/saline solution. Make sure a complete resuspension is achieved with no 
visible aggregates or clumps before starting radiolabeling. (Failure to obtain 
complete resuspension of platelets is a cause for discontinuation of the 
procedure).  
 
Platelet Labeling with 111 Indium-Oxine 
4.6.1 Add 50 to 60 µCi of 111 Indium-Oxine labeling solution (Step 3.13) to 
the washed platelet suspension. Incubate at 20 to 24°C for 20 minutes to 
achieve labeling. (Note: 1 Ci = 3.7x1010 Bq). 
4.6.2 At the end of incubation, add 3.5 mL of ACD-A/saline and 0.5 mL of 
the reserved PPP (from Step 4.4) directly to the incubation tube 
containing the platelets in ACD-A/saline and 111In. 
4.6.3 Centrifuge the tube at 1250 x g at 20 to 24°C for 10 minutes with brake 
off. 
4.6.4 Remove the supernatant and retain in a separate test tube.  Determine 
the activity of this supernatant and the labeled pellet in a dose calibrator. 
Calculate and note the efficiency of labeling by dividing the activity of 
the pellet by the combined activities of the pellet and supernate. 
4.6.5 Gently resuspend the platelet-pellet in 2 mL of PPP reserved previously 
(from Step 4.4). (Failure to obtain complete resuspension of platelets is 
a cause for discontinuation of the procedure.) After complete 
resuspension, add an additional 4 mL of PPP. 
 
Preparation of Platelets for Labeling with Na251CrO4 
 
Labeling of fresh platelets 
5.1.1 Using a 19-gauge needle, collect 43 mL (± 2 mL) of venous blood into a 
60 mL sterile plastic syringe containing 9 mL of ACD-A.  Avoid a 
traumatic venipuncture at the start of blood drawing. Care should be 
taken to avoid excessive negative pressure in the syringe during draw to 
prevent activation of the platelets. (Alternatively, 43 mL of whole blood 
can be collected with 7 mL of ACD-A followed by a 1-2 h holding 
period in Step 5.1.3.). 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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5.1.2 At the same time as 5.1.1, collect one 5 or 7 mL blood sample from the 
subject into an EDTA tube. Mix well. Reserve for determination of 
radiolabel elution (see Step 9.0). 
5.1.3 Using sterile technique, in a laminar flow hood, remove the needle and 
express the contents of the syringe into two sterile 50 mL screw-cap 
conical centrifuge tubes. A hold period of 30 minutes for the ACD-
A/blood mixture before further processing should be utilized. 
5.1.4 Centrifuge (soft spin) the conical tubes at 180 to 200 x g for 15 minutes 
at 20 to 24°C with the brake off to produce red cell-poor PRP.   
5.1.5 Remove the PRP from both tubes with a sterile transfer pipette or spinal 
needle and syringe and place into a single 50 mL sterile conical plastic 
centrifuge tube.  Avoid aspirating any contaminating red cells. 
5.1.6 Add a volume of sterile ACD-A equal to 15% of the volume of PRP to 
the PRP.  Cap the tube and mix gently by inversion. Continue with Step 
5.3. 
 
Preparation of aliquot from stored platelet unit 
5.2.1 Ensure unit is thoroughly mixed and platelets are completely suspended.  
5.2.2 Using sterile technique, in a laminar flow hood, gently remove 20 
(± 2 mL) mL from the stored platelet unit using a 30 mL syringe and 16 
ga needle.   
5.2.3 Remove the needle and express 10 mL of the contents of the syringe 
into each of two 15 mL screw-cap conical labeled centrifuge tubes each 
containing 1.5 mL sterile ACD-A . Cap and mix gently by inversion. 
5.2.4 Centrifuge (soft spin) the conical tubes at 180 to 200 x g for 5 minutes 
at 20 to 24°C with the brake off to produce red cell-poor platelet-rich 
plasma (PRP).   
5.2.5 Remove the PRP with a sterile transfer pipette or spinal needle and 
transfer to two new sterile 15 mL conical plastic centrifuge tubes.  
Avoid aspirating any contaminating red cells. Continue with Step 5.3. 
 
Centrifuge (hard spin) the conical tubes containing the ACD-PRP at 1500-2000 
x g for 15 minutes at 20 to 24ºC with brake off.   
 
Remove the platelet-poor plasma (PPP) produced, as completely as possible 
from both tubes and transfer to a new sterile conical tube. Spin PPP a second 
time (1500-2000 x g for 15 minutes at 20 to 24ºC with brake off), discard pellet 
and reserve supernatant PPP in a sterile tube for later use (Steps 5.6.2 and 
5.6.5).  

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Resuspend the harvested platelet pellet in one tube with 3 mL of ACD-A/saline 
solution.  Using a sterile transfer pipette, transfer the resuspended platelets to 
the other tube containing the platelet pellet.  Resuspend the second platelet 
button. Make sure a complete resuspension is achieved with no visible 
aggregates or clumps before starting the next step. 
 
Platelet Labeling with Na251CrO4 
5.6.1 Add 50 to 100 µCi Na251CrO4 to the washed platelet suspension. 
Incubate at 20 to 24°C for 20 minutes to achieve labeling. 
5.6.2 At the end of incubation, add 2.5 mL of ACD-A/saline and 0.5 mL of 
the reserved PPP (from Step 5.4) directly to the incubation tube 
containing the platelets in ACD-A/saline and Na251CrO4. 
5.6.3 Centrifuge the tube at 1250 x g at 20 to 24°C for 10 minutes with brake 
off. 
5.6.4 Remove the supernatant and retain in a separate test tube.  Determine 
the activity of this supernatant and the labeled pellet in a dose calibrator. 
Calculate and note the efficiency of labeling by dividing the activity of 
the pellet by the combined activities of the pellet and supernatant. 
5.6.5 Gently resuspend the platelet-pellet in 2 mL of PPP reserved previously 
(from Step 5.4). (Failure to obtain complete resuspension of platelets is 
a cause for discontinuation of the procedure.) After complete 
resuspension, add an additional 4 mL of PPP. 
 
Injectate and Standard Preparation 
 
Label five 100 mL volumetric flasks and five 12 x 75 mm polystyrene tubes 
with the isotope used, subject name and/or unit identification, date prepared and 
In STD, Cr STD, and STD I, II or III. 
NOTE: The In STD and the Cr STD are necessary only if calculation of “cross-
up” and “cross-down” corrections requires them. 
Add 1.8 mL 0.9% saline to each 12 x 75 mm standard capped tube.  Weigh 
each tube and record the weights.  Take care that the saline does not touch the 
cap.Add 10 mL of 0.2% SDS-saline solution (1 part saturated (20%) SDS + 99 
parts 0.9% saline) to each flask.  
 
Mix each single labeled platelet aliquots (from Steps 4.6.5 and 5.6.5). Draw 
0.3mL of each suspension into its own 1cc syringe through a 16-gauge needle. 
 
Weigh the filled syringe, needle and needle cover accurately.  Record the 
weight. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Carefully add 0.2 mL of each injectate directly into each flask, “Cr STD” or “In 
STD”, as appropriate.  Add 0.9% saline to the flask to bring to volume.  Mix 
carefully. Weigh the syringe, needle and needle cover accurately and determine 
the mass of labeled injectate placed in each standards flask. 
 
Draw the appropriate radioactive dose of 51Cr-labeled platelets into a labeled 
syringe.  Weigh the syringe and record the radioactive dose. 
NOTE: The activity needed to be injected is dependent on a number of 
variables, such as the gamma counter’s crystal size.  In general, 10-20 µCI are 
required to be injected for accurate determinations. The injectates of the fresh 
and stored platelets should have approximately the same activities.  
 
Remove 111In-labeled platelets from the centrifuge tube until the dose intended 
to be injected is remaining. Measure and record the radioactive dose.  Record 
the weight of the tube. 
 
Carefully verify subject identification on the chromium syringe and indium 
tube.  Inject the 51Cr-labeled platelets into the centrifuge tube containing the 
111In-labeled platelets. 
 
Mix the labeled injectate in the tube.  Prepare final mixed injectate for infusion 
by using an 18 gauge spinal needle and a syringe labeled with subject 
information to aspirate all but at least 1 mL of labeled solution in conical tube. 
(This remaining amount will be used for preparation of standards and 
determination of cell bound activity.)  
 
Remove the spinal needle and replace with a sterile syringe cap. Record the 
weight of the final injectate syringe and cap.   
 
Draw approximately 0.8 mL of the remaining labeled solution from the tube 
containing the 51Cr- and 111In-labeled platelets into a 1cc syringe through a 
16-gauge needle to be used for standard preparation. 
 
Record the weight of the filled syringe, needle, and needle cover. 
 
Carefully add 0.2 mL of the injectate directly into the flask labeled "STD I”.  
Add 0.9% saline to the flask to bring to volume.  Mix carefully. 
 
Reweigh the 1 cc syringe, needle and needle cover and record this weight and 
the difference between the two weights (this being the net weight of the mixed 
injectate added to the standards flask). 
 
Repeat Steps 6.14 and 6.15 for the remaining two flasks. 
 
Pipet 0.2 mL of each standard into the appropriate pre-weighed capped tube 
containing 1.8 mL saline, one sample tube per standard. 
 
Weigh the capped tubes and record the weight.  Take care that the sample does 
not touch the cap. 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Infusion Procedure 
 
Allow recipient to sit in the donor bed to stabilize.  Record pre-infusion vital 
signs. 
 
Verify that recipient's identifiers match the information on the infusion syringe. 
 
Perform venipuncture with a 19-21 gauge butterfly infusion needle.  Draw one 
10 mL EDTA (lavender-top) tube for the pre-infusion sample. 
 
Flush the line with saline to ensure patency of the vein.  Inject labeled platelet 
suspension slowly.  Record exact time (starting from time 1/2 of injectate has 
been infused). 
 
Flush butterfly line and needle with 10 mL of sterile 0.9% sodium chloride.   
 
Remove butterfly needle and apply pressure to injection site.  Apply bandage 
when bleeding has stopped. 
 
Weigh empty infusion syringe, needle and needle cover.  Record weight on the 
data sheet.  Record the net weight of injectate. 
 
Dispose of used supplies in the receptacle labeled for radioactive waste. 
 
Measure and record post-infusion vital signs. 
 
Sampling Procedure and Sample Preparation 
 
One 5-10 mL EDTA (lavender-top) tube sample is to be drawn by direct 
venipuncture at the post-infusion times: 
8.1.1 Pre-infusion (from Step 7.3). 
8.1.2 Optional: 2 hours after infusion. (Collect from the contralateral arm to 
that used for infusion.) 
8.1.3 One sample daily between days 1 through day 7 (except weekends for 
samples after Day 1) and one final sample on day 10, 11 or 12. (The last 
sample is called the “baseline” sample and is used to correct for 
inadvertent labeling of other blood components.) 
NOTE: As the points at the beginning of the curve are most important in 
determining the parameters of the curve, daily sampling on Days 1, 2, 
and 3 afford more accurate projections of recovery and survival 
parameters and should be taken if at all possible. A total of at least 5 
data points from samplings on Days 1-7 should be obtained. 
Delaying the final sample from Day 10 to Day 12 results in lower 
counts and, potentially, counts that are inadequate to achieve desired 
accuracy. Obtaining the final sample on Day 10, if possible, is desirable. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Sample Processing:  
NOTE:  Processing should be completed as soon as possible after 
sampling to prevent post-sampling elution from skewing the proportion 
of activity found in the cellular fraction. 
8.2.1 Prior to the infusion, label and weigh capped 12 x 75 mm polystyrene 
tubes:  one for each sampling time (including pre-sample) for whole 
blood, packed cells and plasma. Tubes for daily samples may be labeled 
and weighed on the day of use or beforehand. 
8.2.2 Just prior to aliquoting sample, thoroughly mix each timed sample from 
the subject manually or for a maximum of two minutes on a rocker. 
8.2.3 Pipet approximately 2.0 mL of the mixed whole blood into the 
appropriate pre-weighed tube using a positive displacement pipettor and 
replace cap. 
8.2.4 Weigh the capped tube and record the weight.  Take care that the sample 
does not touch the cap. 
8.2.5 Pipet approximately 2.0 mL of blood into the appropriate tube labeled 
for packed cells. 
8.2.6 Centrifuge this second set of tubes at 2000 x g for 15 minutes at room 
temperature. 
8.2.7 Pipet the plasma from the packed cell tubes to the appropriate tube 
labeled for plasma. 
8.2.8 Count the "splits" (packed cell and plasma tubes, including the 
injectate). (When possible, count the “splits” on the day of sampling.) 
NOTE: The size of sample volumes may be increased if desired. 
 
Elution of Radioactivity from Labeled Platelets in Whole Blood 
 
Add 10 µL of the mixed injectate into a 5 or 7 mL EDTA tube of blood 
collected from the subject as soon as possible after the infusion of the labeled 
cells procedure. (See Section 4.1.2 or 5.1.2.). 
Note: This timing is anticipating infusion of the radiolabeled platelets at the 
earliest possible time. If delay in infusion is anticipated, the elution steps 
described in this section should be begun so that the separation of the 
supernatant after the next step occurs approximately coincidently with the 
infusion. 
 
Mix and incubate the tube for two hours at 37ºC in a wet incubator (water bath) 
or a dry incubator in a cylinder of water. 
 
Pipet approximately 2 mL into a 12 x 75 mm capped tube. 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
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Spin at 2000g for 15 minutes. 
 
Transfer the supernatant plasma to a capped 12 x 75 mm capped tube. 
 
Count the splits.  
 
The activity found in the cells and plasma will be used to evaluate the in vivo 
cell-bound activity of the labeled platelets for each of the two radiolabels. 
Elution = (CPMsupernate)/[( CPMcells) + (CPMsupernate)] 
 
Counting the Samples  
 
Ensure required quality control and preventive maintenance procedures are 
performed according to the operating instructions. Load racks into counter and 
start counting. Count whole blood samples once all samples from the subject 
have been collected and processed (including Day 10, 11 or 12 sample). (One 
can also count standards and splits, daily.) 
 
Load the gamma counter in a standard order, such as:  blank/background, 
standards, elutions, pre-infusion, and post-infusion timed specimens in order 
collected.   
 
Select appropriate counting program. Set count time to achieve a 2% accuracy, 
including background. 
 
When the tubes have finished counting, label the instrument printout. Verify 
that the background has not drifted significantly.  Verify that all samples 
counted for expected times.  Place the gamma counter printouts in the 
appropriate file. 
 
Transfer all data to appropriate spreadsheets for calculations. Verify accurate 
transcription. 
 
Calculations 
 
Determine corrected CPM /g for each sample. 
Most gamma counters correct automatically for background activity and decay 
during counting as well as for “cross-up” and “cross-down”, that is, counting of 
one isotope’s activity in the other’s channels. Samples and standards must all be 
corrected for these parameters as well as corrected to the same time for 
calculations to be valid. Using these corrected CPM values reported by the 
gamma counter (CPMcorrected), determine CPM/g for standards and timed subject 
samples as follows: 
11.1.1 Standards: STD = CPMcorrected * dilution factor/mass counted, where 
dilution factor = mass of standard/mass of injectate added 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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NOTE: Since the diluent for the standard is water, the specific gravity of 
the standard may be assumed to be 1.00, and the final volume of the 
standard in mL may be taken as its mass in g. 
11.1.2 Timed sample activity: SAMPLE = CPMcorrected /mass counted 
 
Determine cell-bound proportion for timed count adjustment  
Using timed split samples (Section 8.2.8), determine the proportion of 
the activity in each timed sample that can be associated with the cellular 
fraction:  
Cell Bound Fraction (CBFTime t) = (Activity of cells)/(Activity of 
cells + Activity of plasma) = (CPMcell bound)/[( CPMcell bound) + 
(CPMplasma)] 
 
Standard adjustment for injectate elution:  
11.3.1 Determine the mean CPM of the three mixed standards  
(Steps 6.1 and 11.1.1). 
11.3.2 Multiply the mean CPM of the standard samples by the elution 
correction (Step 9.7). 
STDcorrected = STD * (1-Elution) 
 
Adjustment for cell-bound proportion and baseline 
The following two adjustments should be made to the timed sample 
CPM/g counts. These adjustments result in “fully adjusted counts” used 
for curve fitting. 
11.4.1 Adjustment of timed sample for cell-bound proportion (Steps 11.1.2, 
11.2):  
SAMPLE Time t  = SAMPLE (CPM/g) x (CBFTime t ) 
Adjust for non-platelet residual activity baseline, according to the day 
on which the “baseline” sample was taken. (This results in fully 
adjusted timed sample counts.).  
11.4.1.1 
Day 10 
Fully adjusted count = SAMPLE Time t  –  [SAMPLE Day 10 x  (1.20-0.20 
(Time t/Time of Day 10 sample)] 
11.4.1.2 
Or, Day 11 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
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Fully adjusted count = SAMPLE Time t  –  [SAMPLE Day 11 x  (1.22-0.22 
(Time t/Time of Day 11 sample)] 
11.4.1.3 
Or, Day 12 
Fully adjusted count = SAMPLE Time t  –  [SAMPLE Day 12 x  (1.24-0.24 
(Time t/Time of Day 12 sample)] 
Note: “Time t” is the elapsed time in hours from the time of infusion 
(Step 7.4) to the time of sampling. “Time of Day 10 sample” is the 
elapsed time in hours from time of infusion (Step 7.4) to the time the 
sample was obtained on Day 10 following infusion. 
These calculations are based on the published experience of reference 
2.3 and the expectation that 51Cr persistence is the primary source of 
persistent activity. Persistent activity attributable to 111In is less of a 
concern because of its shorter half-life, its higher elution from any 
contaminating red cells that were labeled and the lack of oxine to 
facilitate labeling after elution from platelets. 
 
Determination of expected time0 count following infusion  
11.5.1 Calculate blood volume:   
Male: BV (mL) = ([0.3669*{height (m)} 3] + 0.03219*weight 
(kg) + 0.6041)*1000 
11.5.2 Female: BV (mL) = ([0.3561*{height (m)}3] + [0.03308*weight  (kg)] 
+ 0.1833)*1000Convert the blood volume calculated in 11.5.1 to blood 
mass by multiplying the volume by the specific gravity of whole blood. 
The specific gravity may be taken as 1.05 g/mL, or, if the subject’s 
hematocrit is known, it may be estimated as (1541 + Hct)/1500 (Subject 
hematocrit is expressed as a percentage rather than a decimal; expected 
SG usually between 1.053 and 1.060 g/mL.). 
11.5.3 Determine expected time0 (t=0) count (Steps 11.3.2, 7.0, 11.5.2) 
Time0 Count  = STDcorrected * Infusate mass (g) / Blood mass 
 
Determine recovery for each timed sample (optional) 
Take each fully adjusted sample count (11.4.2) and divide by the 
expected time0 count (11.5.3) to calculate the recovery at each sampling 
time: 
Recovery Time  t = Fully Adjusted Count Time  t / Time0 Count   

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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NOTE: The recovery result that is reported from the study is determined 
using the time0 extrapolation of the curve fitting program. 
 
Kinetic curve fitting 
The fully adjusted timed-sample counts (Step 11.4.2) for times greater than 20 
hours are used for kinetic curve fitting and estimation of recovery and survival. 
That is, the 2 hour time sample is not used for kinetic curve fitting. These 
parameters may be estimated using a validated non-linear curve fitting routine 
found in various statistical and pharmacokinetic computer program packages. 
The use of COST software, one of these software packages, is described below. 
Optionally, the recovery of timed-samples calculated in Step 11.6 may be used. 
Recovery is determined as the extrapolated y-axis intercept (t=0) of the survival 
curve, expressed as the blood cell-bound activity in proportion to the expected 
activity as projected from the blood volume-based dilution.  
The fully adjusted count data (CPM/g) for each timed sample point are entered 
into the COST program as y values, the time after infusion (in hours) as x 
values, and the expected time0 count. (Optionally, the recovery of each timed 
sample from 11.6 may be entered as y values.) 
11.7.1 Activate the COST program. 
11.7.2 Select the appropriate group in COST into which the subject's data will 
be entered. 
11.7.3 Enter the number of data points to be entered. 
11.7.4 Enter the x- (time in hours) and y-values (fully adjusted timed sample 
count, Step 11.4.2) for each timed sample. Double check entry accuracy. 
(Optionally, enter the y value as recoveries from 11.6). 
11.7.5 Enter the time0 count from 11.5.3 into counts/milliliter field. (If the 
individual timed recoveries from 11.6 are used as y values, enter 100 
into the counts/milliliter field in COST to set the 100% recovery point). 
11.7.6 Perform data analyses using the multiple hit model. 
11.7.7 If outliers are found, determine potential source of error and flag for 
review by medical director. Remove point from curve only if clearly a 
spurious result. 
11.7.8 Save and print results. Append to unit records.  

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Completion of Records 
 
Complete, review and file all forms, data and other paperwork. 
 
BEST Protocol Modifications 
Since the inception of the BEST protocol, sites have modified some steps of the protocol to 
BEST 4.2.1 Method.  Some of these modifications include improvements to staff safety, 
adaptations to suit site specific equipment and simplification of the workflow to avoid errors.  
The protocol specific modifications for the BEST 4.2.1 Method are listed in Table 15. 
Table 15 
BEST Version 4.2.1 Modifications 
Section 
BEST Version 4.2.1 Method 
Modified BEST Version 4.2.1 Method 
3.12 
111Indium Oxine in ethanol solution 
containing approximately 1 mCi per vial at 
the time of manufacturer’s calibration.  
111Indium Oxine in ethanol solution 
containing approximately 1-2 mCi per vial at 
the time of manufacturer’s calibration.  
3.13 
111Indium Oxine Labeling solution:  If not 
premixed, aseptically add 4.0 mL sterile 
ACD- A/saline solution to the vial of 
111Indium Oxine to make 5.0 mL of sterile 
111In-Oxine solution for labeling.  Mix well. 
(Stable for one week or until expiration of 
stock 111In oxine solution.). 
1 mCi 111Indium Oxine Labeling solution: If 
not premixed, aseptically add 4.0 mL sterile 
ACD- A/saline solution to the vial of 1mCi 
111Indium Oxine to make 5.0 mL of sterile 
111In-Oxine solution for labeling.   
 
2mCi 111Indium Oxine Labeling solution: 
aseptically add 2mL Oxine Suspension buffer 
to the vial of 2mCi 111Indium Oxine to make 
3mL 111Indium Oxine suspension. Aseptically 
mix approximately 83µL of the 111Indium 
Oxine suspension with 1mL of ACD-A/Saline 
to create 50-60 µCi labeling solution.  
 
Mix well (Stable for one week or until 
expiration of stock 111In Oxine solution). 
4.1.2 
At the same time as 4.1.1, collect one 5 or 7 
mL blood sample from the subject into an 
EDTA tube. Mix well. Reserve for 
determination of radiolabel elution (see Step 
9.0.). 
This tube can be taken here or during draw 
listed in Section 7.3. 
4.2.2 
Using sterile technique, in a laminar flow 
hood, gently remove 10 mL from the stored 
platelet unit using a 20 mL syringe and 16 ga 
needle.  
Using sterile technique, in a laminar flow 
hood, gently remove two - 10mL from the 
stored platelet unit using sterilely docked 
transfer packs. 
4.2.3 
Remove the needle and express the contents 
of the syringe into a 15 mL screw-cap conical 
labeled centrifuge tubes containing 1.5 mL 
sterile ACD-A.  Cap and mix gently by 
inversion. 
Express the contents of the syringe into two – 
15 or 50 mL screw-cap conical labeled 
centrifuge tubes each containing 1.5 mL 
sterile ACD-A (15% by volume, pH 4.5 – 
5.5).  Cap and mix gently by inversion or 
swirling. 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Section 
BEST Version 4.2.1 Method 
Modified BEST Version 4.2.1 Method 
4.2.5 
Remove the PRP with a sterile transfer pipette 
or spinal needle and syringe and place into a 
new 15 mL sterile conical plastic centrifuge 
tube.  
Remove PRP with a sterile transfer pipette or 
spinal needle and syringe and place into a new 
15 or 50 mL sterile conical plastic centrifuge 
tube. 
4.4 
Remove the platelet-poor plasma (PPP) 
produced, as completely as possible and 
transfer to a new sterile conical tube. Spin 
PPP a second time (1500-2000 x g for 15 
minutes with brake off), discard pellet and 
reserve supernatant PPP in a sterile tube for 
later use (Steps 4.6.2 and 4.6.5). 
Remove the platelet-poor plasma (PPP) 
produced, as completely as possible and 
transfer to a new sterile conical tube. Spin 
PPP a second time (1500-2000 x g for 15 
minutes with brake off or brake minimum to 
allow for addition of PPP to platelet sample 
within 20 minutes of platelet labeling (Section 
4.6.1)), discard pellet and reserve supernatant 
PPP in a sterile tube for later use (Steps 4.6.2 
and 4.6.5). 
4.5 
Using a sterile pipet, resuspend the harvested 
platelet pellet with 2 mL of ACD-A/saline 
solution. Make sure a complete resuspension 
is achieved with no visible aggregates or 
clumps before starting radiolabeling. (Failure 
to obtain complete resuspension of platelets is 
a cause for discontinuation of the procedure). 
Using a sterile pipet, resuspend the harvested 
platelet pellet with 2 mL of ACD-A/saline 
solution. Make sure a complete resuspension 
is achieved with no visible aggregates or 
clumps before starting radiolabeling. (Failure 
to obtain complete resuspension of platelets is 
a cause for discontinuation of the procedure). 
 
Before proceeding to radiolabeling the 
platelets, one aliquot of Test platelets will be 
stopped and used only for in vitro analysis. 
4.6.3 
Centrifuge the tube at 1250 x g at 20 to 24°C 
for 10 minutes with brake off. 
Centrifuge the tube at 1200 to 1250 x g at 20 
to 24°C for 10 minutes with brake off. 
5.2.2 
Using sterile technique, in a laminar flow 
hood, gently remove 20 (± 2 mL) mL from the 
stored platelet unit using a 30 mL syringe and 
16 ga needle.   
Using sterile technique, in a laminar flow 
hood, gently remove two – 20mL from the 
stored platelet unit using sterilely docked 
transfer packs. 
5.2.3 
Remove the needle and express 10 mL of the 
contents of the syringe into each of two 15 
mL screw-cap conical labeled centrifuge tubes 
containing 1.5 mL sterile ACD-A . Cap and 
mix gently by inversion. 
Express 10 mL of the contents of the syringes 
into four - 50 mL screw-cap conical labeled 
centrifuge tubes each containing 1.5 mL 
sterile ACD-A (15% by volume). Cap and 
mix gently by inversion or swirling. 
5.2.5 
Remove the PRP with a sterile transfer pipette 
or spinal needle and syringe and place into a 
new 15 mL sterile conical plastic centrifuge 
tube.   
Remove PRP with a sterile transfer pipette or 
spinal needle and syringe and place into a new 
50 mL sterile conical plastic centrifuge tubes.   
5.4 
Remove the platelet-poor plasma (PPP) 
produced, as completely as possible from both 
tubes and transfer to a new sterile conical 
tube. Spin PPP a second time (1500-2000 x g 
for 15 minutes at 20 to 24ºC with brake off), 
discard pellet and reserve supernatant PPP in 
Remove the platelet-poor plasma (PPP) 
produced, as completely as possible from both 
tubes and transfer to a new sterile conical 
tube. Spin PPP a second time (1500-2000 x g 
for 15 minutes at 20 to 24ºC with brake off or 
brake minimum to allow for addition of PPP 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Section 
BEST Version 4.2.1 Method 
Modified BEST Version 4.2.1 Method 
a sterile tube for later use (Steps 5.6.2 and 
5.6.5).  
to platelet sample within 20 minutes of 
platelet labeling (Section 5.6.1), discard pellet 
and reserve supernatant PPP in a sterile tube 
for later use (Steps 5.6.2 and 5.6.5).  
5.5 
Resuspend the harvested platelet pellet in one 
tube with 3 mL of ACD-A/saline solution.  
Using a sterile transfer pipette, transfer the 
resuspended platelets to the other tube 
containing the platelet pellet.  Resuspend the 
second platelet button. Make sure a complete 
resuspension is achieved with no visible 
aggregates or clumps before starting the next 
step. 
Resuspend the harvested platelet pellet in one 
tube with 3 mL of ACD-A/saline solution.  
For Fresh platelets using a sterile transfer 
pipette, transfer the resuspended platelets to 
the other tube containing the platelet pellet 
and resuspend the second platelet button. 
Make sure a complete resuspension is 
achieved with no visible aggregates or clumps 
before starting the next step. 
 
Before proceeding to radiolabeling the 
platelets, one aliquot of Test platelets will be 
stopped and used only for in vitro analysis. 
5.6.3 
Centrifuge the tube at 1250 x g at 20 to 24°C 
for 10 minutes with brake off. 
Centrifuge the tube at 1200 to 1250 x g at 20 
to 24°C for 10 minutes with brake off. 
7.3 
Perform venipuncture with a 19-21 gauge 
butterfly infusion needle.  Draw one 10 mL 
EDTA (lavender-top) tube for the pre-infusion 
sample. 
Perform venipuncture with a 19 gauge 
butterfly infusion needle.  Draw one (or 2 if 
tube for elution was not drawn earlier) 10 mL 
EDTA (lavender-top) tube for the pre-infusion 
sample. 
7.7 
Weigh empty infusion syringe, needle and 
needle cover.  Record weight on the data 
sheet.  Record the net weight of injectate. 
Remove needle, cap syringe with syringe cap, 
and weigh syringe with syringe cap. Record 
weight on the data sheet.  Record the net 
weight of injectate. 
8.1.2 
Optional: 2 hours after infusion. (Collect from 
the contralateral arm to that used for 
infusion.). 
Collect blood draw at 1 and 2 hours after 
infusion. (Collect from the contralateral arm 
to that used for infusion.). 
8.1.3 
One sample daily between days 1 through day 
7 (except weekends for samples after Day 1) 
and one final sample on day 10, 11 or 12. 
(The last sample is called the “baseline” 
sample and is used to correct for inadvertent 
labeling of other blood components.). 
Sample on days 1, 2, 3, 4 (or 5 or 6), 7 (or 8) 
and one final sample on day 10, 11 or 12. 
(The last sample is called the “baseline” 
sample and is used to correct for inadvertent 
labeling of other blood components.). 
8.2.3 
Pipet approximately 2.0 mL of the mixed 
whole blood into the appropriate pre-weighed 
tube using a positive displacement pipettor 
and replace cap. 
This sample is prepared and counted 
duplicate. 
9.3 – 9.6 
Pipet approximately 2 mL into a 12 x 75 mm 
capped tube. 
This sample is prepared and counted 
duplicate. 
 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Radiolabeling Procedure for Platelets (Variant 1) 
Platelet Radiolabeling Procedure 4.2.1 with Variant 1 Modifications  
(shown as strikethrough text indicating deletions or capitalized text 
indicating additions) 
The Biomedical Excellence for Safer Transfusion (BEST) Collaborative 
 
Corresponding Author 
 
James P. AuBuchon, MD 
Chair, BEST Collaborative 
Department of Pathology 
Dartmouth-Hitchcock Medical Center 
One Medical Center Drive 
 Lebanon, New Hampshire 03756 USA 
 
PHONE: 603-650-8693 
FAX: 603-650-4845 
EMAIL: JAMES.P.AUBUCHON@HITCHCOCK.ORG 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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INTRODUCTION 
This file contains a procedure for the radiolabeling of both stored and fresh platelets 
and their autologous reinfusion for the determination of recovery and survival as published in 
the November, 2006 supplement to Transfusion. It is being made available on the BEST 
website in a downloadable format to facilitate implementation as the routine procedure in 
laboratories performing this kind of work. When referencing this procedure, please cite the 
Transfusion Supplement. 
As detailed in other manuscripts in the Supplement, this procedure was derived from 
the validated, seminal work of Andrew Heaton, Stein Holme and colleagues in Norfolk, 
Virginia, and adapted for application to Scott Murphy’s insightful approach of comparing a 
new platelet preparation to fresh platelets from the same subject. The effort of adapting the 
procedure (kindly made available by the American Red Cross) for this purpose and thoroughly 
discussing and debating its content were undertaken by the members of the Biomedical 
Excellence for Safer Transfusion (BEST) Collaborative through multiple meetings over a two-
year period. The validation of the adaptation and its application can be found reviewed in other 
papers in this Supplement. Deviations from this procedure should be accompanied by 
appropriate validation and documentation. 
Many individuals contributed substantial time and effort in developing, reviewing and 
validating this procedure. In particular, the leadership of the authors of the other articles in this 
Supplement should be noted as well as the meticulous reviewing undertaken by Lisa Cooke, 
Louise Herschel, Jill Roger, Sherrill Slichter, and Ralph Vassallo.  
BEST welcomes receipt of comments regarding the procedure and suggestions for further 
development. 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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PROCEDURE 
 
Purpose: To describe a technique for radioisotopic labeling and infusion of fresh 
or stored platelets with 111 In Oxine (111Indium) and Na251CrO4 (51Chromium). 
 
While the measurement of platelet recovery and survival can be used for a 
variety of purposes, this procedure is intended for assessment of the in vivo 
viability of platelets that have been stored and/or treated in comparison with 
fresh platelets from the same subject 
 
This procedure includes the basic calculations for determining platelet recovery 
and survival. The recommended manner of comparing the results between 
control and test infusions is through comparison of the paired differences and 
calculation of upper confidence intervals as detailed by Dumont in this 
supplement (See 2.6.) 
 
Applicable documents: 
 
Snyder EL, Moroff G, Simon T, Heaton A, and Members of the Ad Hoc 
Platelet Radiolabeling Study Group.  Recommended methods for conducting 
radiolabeled platelet survival studies.  Transfusion 1986; 26:37-42 
 
Panel Report, International Committee for Standardization in Hematology.  
Recommended methods for radioisotopic platelet survival studies.  Blood 1977; 
50:1137-1144 
 
Holme S., Heaton A., Roodt J. Concurrent label method with 111In and 51Cr 
allows accurate evaluation of platelet viability of stored platelet concentrates. 
Brit J Haematol 1993;84:717-723. 
 
Nadler SB, Hidalgo JU, Bloch T. Prediction of blood volume in normal human 
adults. Surgery 1962;51:224-232 
 
Lötter MG, Rabe WL, Van Zyl JM, et al. A computer program in compiled 
BASIC for the IBM personal computer to calculate the mean platelet survival 
time with the multiple-hit and weighted mean methods. Comput Biol Med 
1988;18:305-15 
 
Dumont LJ. Analysis and reporting of platelet kinetic studies. Transfusion 
2006;46 (Suppl) 67S-73S 
 
Equipment/Supplies/Reagents 
 
Calibrated, temperature-controlled, variable speed, swinging bucket centrifuge. 
 
Calibrated electronic balance, accurate to ± 0.0002 g. 
 
Gamma counter with 3 inch sodium chloride crysta 
 
Laminar flow hood. 
 
9-21 gauge butterfly or straight needle 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Sterile transfer pipettes (3.2 mL draw) 
 
15 mL and 50 mL sterile conical polypropylene plastic tubes (Note: Although 
some procedural steps specify exact sizes, an alternative appropriate size may 
be substituted.) 
 
Evacuated sample tubes with EDTA (powdered or dry “lavender tops”). 
 
ACD-A: Anticoagulant Citrate Dextrose Solution - Formula A 
 
ACD-A/ Saline Solution: mix 1 part ACD-A to 7 parts sterile (0.9%) Normal 
Saline, adjusted to pH 6.5 to 6.8 with 1 N NaOH; sterilize by filtration. [Stable 
for one week when stored in refrigerator; warm to room temperature (20-24°C) 
before use.] 
 
0.22µm Sterilizing Filter Unit 
 
111Indium Oxine in ethanol solution containing approximately 1 mCi per vial at 
the time of manufacturer’s calibration. Use within 7 d for platelet labeling. 
(Changes in ethanol/oxine ratio over time may result in changes in platelet 
function.) 
 
111Indium Oxine Labeling solution:  If not premixed, aseptically add 4.0 mL 
sterile ACD- A/saline solution to the vial of 111Indium Oxine to make 5.0 mL of 
sterile 111In-Oxine solution for labeling.  Mix well. (Stable for one week or until 
expiration of stock 111In oxine. solution.) 
 
Na2 51CrO4, Chromium-51 
 
18 gauge spinal needles sterile 
 
Assorted sterile syringes and needles (Note: Although some procedural steps 
specify exact sizes, any appropriate size may be substituted.) 
 
Positive displacement pipettes for whole blood aliquots. 
 
Assorted size pipettes and tips 
 
SDS (Sodium Dodecyl Sulfate) 20%; Dissolve 20g sodium dodecyl sulfate in 
100 mL of distilled water.  (Store at room temperature for up to one year.). 
NOTE: All vessels holding platelets or plasma that will be reinfused must be 
properly labeled to definitively identify the subject 
 
Preparation of Platelets for Labeling with 111Indium Oxine  
 
Preparation of freshly collected platelets 
4.1.1 Using a 19-gauge needle, collect 43 mL (± 2 mL) of venous blood into a 
60 mL sterile plastic syringe containing 9 mL of ACD-A.  Avoid a 
traumatic venipuncture at the start of blood drawing. Care should be 
taken to avoid excessive negative pressure in the syringe during draw to 
prevent activation of the platelets. (Alternatively, 43 mL of whole blood 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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can be collected with 7 mL of ACD-A followed by a 1-2 h holding 
period in Step 4.1.3.) 
4.1.2 At the same time as 4.1.1, collect one 5 or 7 mL blood sample from the 
subject into an EDTA tube. Mix well. Reserve for determination of 
radiolabel elution (see Step 9.0) 
4.1.3 Using sterile technique, in a laminar flow hood, remove the needle and 
express the contents of the syringe into two sterile 50 mL screw-cap 
conical centrifuge tubes. A hold period of 30 minutes for the ACD-
A/blood mixture before further processing should be utilized. 
4.1.4 Centrifuge (soft spin) the conical tubes at 180 to 200 x g for 15 minutes 
at 20 to 24°C with the brake off to produce red cell-poor platelet–rich 
plasma (PRP) 
4.1.5 Remove the PRP from both tubes with a sterile transfer pipette or spinal 
needle and syringe and place into a single 50 mL sterile conical plastic 
centrifuge tube.  Avoid aspirating any contaminating red cells. 
4.1.6 Add a volume of sterile ACD-A equal to 15% of the volume of PRP to 
the PRP.  Cap the tube and mix gently by inversion. Continue with Step 
4.3 
 
Preparation of aliquot from stored platelet unit 
4.2.1 Ensure unit is thoroughly mixed and platelets are completely suspended.  
4.2.2 Using sterile technique, in a laminar flow hood, gently remove 10 mL 
from the stored platelet unit using a 20 mL syringe and 16 ga needle.   
4.2.3 Remove the needle and express the contents of the syringe into a 15 mL 
screw-cap conical labeled centrifuge tubes containing 1.5 mL sterile 
ACD-A. Cap and mix gently by inversion 
4.2.4 Centrifuge (soft spin) the conical tubes at 180 to 200 x g for 5 minutes 
at 20 to 24ºC with the brake off to produce red cell poor platelet rich 
plasma (PRP). 
4.2.5 Remove the PRP with a sterile transfer pipette or spinal needle and 
syringe and place into a new 15 mL sterile conical plastic centrifuge 
tube.  Avoid aspirating any contaminating red cells. Continue with Step 
4.3. 
 
Centrifuge (hard spin) the ACD-PRP (FRESH SAMPLE) OR STORED 
PLATELET SAMPLE at 1500-2000 x g for 15 minutes at 20 to 24ºC with 
brake off 
 
Remove the platelet-poor plasma (PPP) produced, as completely as possible 
and transfer to a new sterile conical tube. Spin PPP a second time (1500-
2000 x g for 15 minutes with brake off), discard pellet and reserve supernatant 
PPP in a sterile tube for later use (Steps 4.6.2 and 4.6.5) 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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Using a sterile pipet, resuspend the harvested platelet pellet with 2 mL of ACD-
A/saline solution. Make sure a complete resuspension is achieved with no 
visible aggregates or clumps before starting radiolabeling. (Failure to obtain 
complete resuspension of platelets is a cause for discontinuation of the 
procedure.)  
 
Platelet Labeling with 111 Indium-Oxine 
4.6.1 Add 50 to 60 µCi of 111 Indium-Oxine labeling solution (Step 3.13) to 
the washed platelet suspension. Incubate at 20 to 24°C for 20 minutes to 
achieve labeling. (Note: 1 Ci = 3.7x1010 Bq) 
4.6.2 At the end of incubation, add 3.5 mL of ACD-A/saline and 0.5 mL of 
STORED AUTOLOGOUS PLASMA the reserved PPP (from Step 
4.4) directly to the incubation tube containing the platelets in ACD-
A/saline and 111In. 
4.6.3 Centrifuge the tube at 1250 x g at 20 to 24°C for 10 minutes with brake 
off. 
4.6.4 Remove the supernatant and retain in a separate test tube.  Determine 
the activity of this supernatant and the labeled pellet in a dose calibrator. 
Calculate and note the efficiency of labeling by dividing the activity of 
the pellet by the combined activities of the pellet and supernatant. 
4.6.5 Gently resuspend the platelet-pellet in 2 mL of STORED 
AUTOLOGOUS PLASMA PPP reserved previously (from Step 4.4). 
(Failure to obtain complete resuspension of platelets is a cause for 
discontinuation of the procedure.) After complete resuspension, add an 
additional 4 mL of STORED AUTOLOGOUS PLASMA PPP. 
 
Preparation of Platelets for Labeling with Na251CrO4 
 
Labeling of fresh platelets 
5.1.1 Using a 19-gauge needle, collect 43 mL (± 2 mL) of venous blood into a 
60 mL sterile plastic syringe containing 9 mL of ACD-A.  Avoid a 
traumatic venipuncture at the start of blood drawing. Care should be 
taken to avoid excessive negative pressure in the syringe during draw to 
prevent activation of the platelets. (Alternatively, 43 mL of whole blood 
can be collected with 7 mL of ACD-A followed by a 1-2 h holding 
period in Step 5.1.3.) 
5.1.2 At the same time as 5.1.1, collect one 5 or 7 mL blood sample from the 
subject into an EDTA tube. Mix well. Reserve for determination of 
radiolabel elution (see Step 9.0) 
5.1.3 Using sterile technique, in a laminar flow hood, remove the needle and 
express the contents of the syringe into two sterile 50 mL screw-cap 
conical centrifuge tubes. A hold period of 30 minutes for the ACD-
A/blood mixture before further processing should be utilized 

Cerus Corporation 
Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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5.1.4 Centrifuge (soft spin) the conical tubes at 180 to 200 x g for 15 minutes 
at 20 to 24°C with the brake off to produce red cell-poor PRP.  
5.1.5 Remove the PRP from both tubes with a sterile transfer pipette or spinal 
needle and syringe and place into a single 50 mL sterile conical plastic 
centrifuge tube.  Avoid aspirating any contaminating red cells. 
5.1.6 Add a volume of sterile ACD-A equal to 15% of the volume of PRP to 
the PRP.  Cap the tube and mix gently by inversion. Continue with 
Step 5.3 
 
Preparation of aliquot from stored platelet unit 
5.2.1 Ensure unit is thoroughly mixed and platelets are completely suspended.  
5.2.2 Using sterile technique, in a laminar flow hood, gently remove 
20 (± 2 mL) mL from the stored platelet unit using a 30 mL syringe and 
16 ga needle  
5.2.3 Remove the needle and express 10 mL of the contents of the syringe 
into each of two 15 mL screw-cap conical labeled centrifuge tubes each 
containing 1.5 mL sterile ACD-A . Cap and mix gently by inversion 
5.2.4 Centrifuge (soft spin) the conical tubes at 180 to 200 x g for 5 minutes 
at 20 to 24ºC with the brake off to produce red cell poor platelet rich 
plasma (PRP). 
5.2.5 Remove the PRP with a sterile transfer pipette or spinal needle and 
transfer to two new sterile 15 mL conical plastic centrifuge tubes. Avoid 
aspirating any contaminating red cells. Continue with Step 5.3.   
 
Centrifuge (hard spin) the conical tubes containing the ACD-PRP (FRESH 
SAMPLE) OR STORED PLATELET SAMPLE at 1500-2000 x g for 15 
minutes at 20 to 24ºC with brake off 
 
Remove the platelet-poor plasma (PPP) produced, as completely as possible 
from both tubes and transfer to a new sterile conical tube. Spin PPP a second 
time (1500–2000 x g for 15 minutes at 20 to 24ºC with brake off), discard pellet 
and reserve supernatant PPP in a sterile tube for later use (Steps 5.6.2 and 
5.6.5). 
 
Resuspend the harvested platelet pellet in one tube with 3 mL of ACD-A/saline 
solution.  Using a sterile transfer pipette, transfer the resuspended platelets to 
the other tube containing the platelet pellet.  Resuspend the second platelet 
button. Make sure a complete resuspension is achieved with no visible 
aggregates or clumps before starting the next step 
 
Platelet Labeling with Na251CrO4 
5.6.1 Add 50 to 100 µCi Na251CrO4 to the washed platelet suspension. 
Incubate at 20 to 24°C for 20 minutes to achieve labeling 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
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5.6.2 At the end of incubation, add 2.5 mL of ACD-A/saline and 0.5 mL 
STORED AUTOLOGOUS PLASMA of the reserved PPP (from Step 
5.4) directly to the incubation tube containing the platelets in ACD-
A/saline and Na251CrO4 
5.6.3 Centrifuge the tube at 1250 x g at 20 to 24°C for 10 minutes with brake 
off 
5.6.4 Remove the supernatant and retain in a separate test tube.  Determine 
the activity of this supernatant and the labeled pellet in a dose calibrator. 
Calculate and note the efficiency of labeling by dividing the activity of 
the pellet by the combined activities of the pellet and supernatant 
5.6.5 Gently resuspend the platelet-pellet in 2 mL of STORED 
AUTOLOGOUS PLASMA PPP reserved previously (from Step 5.4). 
(Failure to obtain complete resuspension of platelets is a cause for 
discontinuation of the procedure.) After complete resuspension, add an 
additional 4 mL of STORED AUTOLOGOUS PLASMA PPP. 
 
Injectate and Standard Preparation 
 
Label five 100 mL volumetric flasks and five 12 x 75 mm polystyrene tubes 
with the isotope used, subject name and/or unit identification, date prepared and 
In STD, Cr STD, and STD I, II or III 
NOTE: The In STD and the Cr STD are necessary only if calculation of 
“cross--p” and “cross-down” corrections requires them 
 
Add 1.8 mL 0.9% saline to each 12 x 75 mm standard capped tube.  Weigh 
each tube and record the weights.  Take care that the saline does not touch the 
cap. 
 
Add 10 mL of 0.2% SDS-saline solution (1 part saturated (20%) SDS + 99 parts 
0.9% saline) to each flask. 
 
Mix each single labeled platelet aliquots (from Steps 4.6.5 and 5.6.5). Draw 
0.3mL of each suspension into its own 1cc syringe through a 16-gauge needle. 
 
Weigh the filled syringe, needle and needle cover accurately.  Record the 
weight 
 
Carefully add 0.2 mL of each injectate directly into each flask, “Cr STD” or “In 
STD”, as appropriate.  Add 0.9% saline to the flask to bring to volume.  Mix 
carefully. Weigh the syringe, needle and needle cover accurately and determine 
the mass of labeled injectate placed in each standards flask 
 
Draw the appropriate radioactive dose of 51Cr-labeled platelets into a labeled 
syringe.  Weigh the syringe, and record the radioactive dose 
NOTE: The activity needed to be injected is dependent on a number of 
variables, such as the gamma counter’s crystal size.  In general, 10-20 µCI are 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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required to be injected for accurate determinations. The injectates of the fresh 
and stored platelets should have approximately the same activities  
 
Remove 111In-labeled platelets from the centrifuge tube until the dose intended 
to be injected is remaining. Measure and record the radioactive dose.  Record 
the weight of the tube 
 
Carefully verify subject identification on the chromium syringe and indium 
tube.  Inject the 51Cr-labeled platelets into the centrifuge tube containing the 
111In-labeled platelets 
 
Mix the labeled injectate in the tube.  Prepare final mixed injectate for infusion 
by using an 18 gauge spinal needle and a syringe labeled with subject 
information to aspirate all but at least 1 mL of labeled solution in conical tube. 
(This remaining amount will be used for preparation of standards and 
determination of cell bound activity.)  
 
Remove the spinal needle and replace with a sterile syringe cap. Record the 
weight of the final injectate syringe and cap 
 
Draw approximately 0.8 mL of the remaining labeled solution from the tube 
containing the 51Cr- and 111In-labeled platelets into a 1cc syringe through a 
16-gauge needle to be used for standard preparation 
 
Record the weight of the filled syringe, needle, and needle cover 
 
Carefully add 0.2 mL of the injectate directly into the flask labeled "STD I”.  
Add 0.9% saline to the flask to bring to volume.  Mix carefully 
 
Reweigh the 1 cc syringe, needle and needle cover and record this weight and 
the difference between the two weights (this being the net weight of the mixed 
injectate added to the standards flask) 
 
Repeat Steps 6.14 and 6.15 for the remaining two flasks 
 
Pipet 0.2 mL of each standard into the appropriate pre-weighed capped tube 
containing 1.8 mL saline, one sample tube per standard. ALTERNATIVELY, 
IF THIS PROCESS RESULTS IN STANDARD COUNTS LESS THAN 
10-FOLD HIGHER THAN BACKGROUND, PIPET 2.0 ML OF THE 
STANDARD FROM THE 100ML DILUTED VOLUMETRIC FLASK INTO 
AN APPROPRIATE PRE-WEIGHED CAPPED TUBE FOR DIRECT 
COUNTING 
 
Weigh the capped tubes and record the weight.  Take care that the sample does 
not touch the cap 
 
Infusion Procedure 
 
Allow recipient to sit in the donor bed to stabilize.  Record pre-infusion vital 
signs 
 
Verify that recipient's identifiers match the information on the infusion syringe 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
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Perform venipuncture with a 19-21 gauge butterfly infusion needle.  Draw one 
10 mL EDTA (lavender-top) tube for the pre-infusion sample 
 
Flush the line with saline to ensure patency of the vein.  Inject labeled platelet 
suspension slowly.  Record exact time (starting from time 1/2 of injectate has 
been infused) 
 
Flush butterfly line and needle with 10 mL of sterile 0.9% sodium chloride   
 
Remove butterfly needle and apply pressure to injection site.  Apply bandage 
when bleeding has stopped 
 
Weigh empty infusion syringe, needle and needle cover.  Record weight on the 
data sheet.  Record the net weight of injectate 
 
Dispose of used supplies in the receptacle labeled for radioactive waste 
 
Measure and record post-infusion vital signs 
 
Sampling Procedure and Sample Preparation 
 
One 5-10 mL EDTA (lavender-top) tube sample is to be drawn by direct 
venipuncture at the post-infusion times: 
8.1.1 Pre-infusion (from Step 7.3) 
8.1.2 Optional: 2 hours after infusion. (Collect from the contralateral arm to 
that used for infusion.) 
8.1.3 One sample daily between days 1 through day 7 (except weekends for 
samples after Day 1) and one final sample on day 10, 11 or 12. (The last 
sample is called the “baseline” sample and is used to correct for 
inadvertent labeling of other blood components.)  
NOTE: As the points at the beginning of the curve are most important in 
determining the parameters of the curve, daily sampling on Days 1, 2, 
and 3 afford more accurate projections of recovery and survival 
parameters and should be taken if at all possible. A total of at least 5 
data points from samplings on Days 1-7 should be obtained 
Delaying the final sample from Day 10 to Day 12 results in lower 
counts and, potentially, counts that are inadequate to achieve desired 
accuracy. Obtaining the final sample on Day 10, if possible, is desirable. 
 
Sample Processing:  
NOTE:  Processing should be completed as soon as possible after 
sampling to prevent post-sampling elution from skewing the proportion 
of activity found in the cellular fraction. 
8.2.1 Prior to the infusion, label and weigh capped 12 x 75 mm polystyrene 
tubes:  one for each sampling time (including pre-sample) for whole 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
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blood, packed cells and plasma. Tubes for daily samples may be labeled 
and weighed on the day of use or beforehand 
8.2.2 Just prior to aliquoting sample, thoroughly mix each timed sample from 
the subject manually or for a maximum of two minutes on a rocker 
8.2.3 Pipet approximately 2.0 mL of the mixed whole blood into the 
appropriate pre-weighed tube using a positive displacement pipettor and 
replace cap 
8.2.4 Weigh the capped tube and record the weight.  Take care that the sample 
does not touch the cap 
8.2.5 Pipet approximately 2.0 mL of blood into the appropriate tube labeled 
for packed cells 
8.2.6 Centrifuge this second set of tubes at 2000 x g for 15 minutes at room 
temperature 
8.2.7 Pipet the plasma from the packed cell tubes to the appropriate tube 
labeled for plasma 
8.2.8 Count the "splits" (packed cell and plasma tubes, including the 
injectate). (When possible, count the “splits” on the day of sampling.) 
NOTE: The size of sample volumes may be increased if desired 
 
Elution of Radioactivity from Labeled Platelets in Whole Blood 
 
Add 10 µL of the mixed injectate into a 5 or 7 mL EDTA tube of blood 
collected from the subject as soon as possible after the infusion of the labeled 
cells procedure. (See Section 4.1.2 or 5.1.2.) 
Note: This timing is anticipating infusion of the radiolabeled platelets at the 
earliest possible time. If delay in infusion is anticipated, the elution steps 
described in this section should be begun so that the separation of the 
supernatant after the next step occurs approximately coincidently with the 
infusion 
 
Mix and incubate the tube for two hours at 37ºC in a wet incubator (water bath) 
or a dry incubator in a cylinder of water 
 
Pipet approximately 2 mL into a 12 x 75 mm capped tube. 
 
Spin at 2000g for 15 minutes 
 
Transfer the supernatant plasma to a capped 12 x 75 mm capped tube 
 
Count the splits 
 
The activity found in the cells and plasma will be used to evaluate the in vivo 
cell-bound activity of the labeled platelets for each of the two radiolabels 

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Elution = (CPMsupernate)/[(CPMcells) + (CPMsupernate)] 
 
Counting the Samples  
 
Ensure required quality control and preventive maintenance procedures are 
performed according to the operating instructions. Load racks into counter and 
start counting. Count whole blood samples once all samples from the subject 
have been collected and processed (including Day 10, 11 or 12 sample). (One 
can also count standards and splits, daily.) 
 
Load the gamma counter in a standard order, such as:  blank/background, 
standards, elutions, pre-infusion, and post-infusion timed specimens in order 
collected  
 
Select appropriate counting program. Set count time to achieve a 2% accuracy, 
including background. 
 
When the tubes have finished counting, label the instrument printout. Verify 
that the background has not drifted significantly.  Verify that all samples 
counted for expected times.  Place the gamma counter printouts in the 
appropriate file 
 
Transfer all data to appropriate spreadsheets for calculations. Verify accurate 
transcription 
 
Calculations 
 
Determine corrected CPM /g for each sample 
Most gamma counters correct automatically for background activity and decay 
during counting as well as for “cross-up” and “cross-down”, that is, counting of 
one isotope’s activity in the other’s channels. Samples and standards must all be 
corrected for these parameters as well as corrected to the same time for 
calculations to be valid. Using these corrected CPM values reported by the 
gamma counter (CPMcorrected), determine CPM/g for standards and timed subject 
samples as follows: 
11.1.1 Standards: STD = CPMcorrected * dilution factor/mass counted, where 
dilution factor = mass of standard/mass of injectate added 
NOTE: Since the diluent for the standard is water, the specific gravity of 
the standard may be assumed to be 1.00, and the final volume of the 
standard in mL may be taken as its mass in g. 
Dilution of standards must be calibrated to ensure that measurements at 
baseline are > 10 fold higher than background 
11.1.2 Timed sample activity: SAMPLE = CPMcorrected /mass counted 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
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Determine cell-bound proportion for timed count adjustment  
Using timed split samples (Section 8.2.8), determine the proportion of the 
activity in each timed sample that can be associated with the cellular fraction: 
Cell Bound Fraction (CBFTime t) = (Activity of cells)/(Activity of cells + 
Activity of plasma) = (CPMcell bound)/[(CPMcell bound) + (CPMplasma)] 
 
Standard adjustment for injectate elution:  
11.3.1 Determine the mean CPM of the three mixed standards (Steps 6.1 and 
11.1.1) 
11.3.2 Multiply the mean CPM of the standard samples by the elution 
correction (Step 9.7) 
STDcorrected = STD * (1-Elution) 
 
Adjustment for cell-bound proportion and baseline 
The following two adjustments should be made to the timed sample CPM/g 
counts. These adjustments result in “fully adjusted counts” used for curve 
fitting 
11.4.1 Adjustment of timed sample for cell-bound proportion (Steps 11.1.2, 
11.2):  
SAMPLE Time t = SAMPLE (CPM/g) x (CBFTime t) 
11.4.2 Adjust for non-platelet residual activity baseline, according to the day 
on which the “baseline” sample was taken. (This results in fully 
adjusted timed sample counts.)  
11.4.2.1 
Day 10 
Fully adjusted count = SAMPLE Time t – [SAMPLE Day 10 x (1.20-
0.20 (Time t/Time of Day 10 sample)] 
11.4.2.2 
Or, Day 11 
Fully adjusted count = SAMPLE Time t – [SAMPLE Day 11 x 
(1.22-0.22 (Time t/Time of Day 11 sample)] 
11.4.2.3 
Or, Day 12 
Fully adjusted count = SAMPLE Time t – [SAMPLE Day 12 x (1.24-0.24 
(Time t/Time of Day 12 sample)] 
Note: “Time t” is the elapsed time in hours from the time of infusion 
(Step 7.4) to the time of sampling. “Time of Day 10 sample” is the 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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elapsed time in hours from time of infusion (Step 7.4) to the time the 
sample was obtained on Day 10 following infusion 
These calculations are based on the published experience of reference 
2.3 and the expectation that 51Cr persistence is the primary source of 
persistent activity. Persistent activity attributable to 111In is less of a 
concern because of its shorter half-life, its higher elution from any 
contaminating red cells that were labeled and the lack of oxine to 
facilitate labeling after elution from platelets 
 
Determination of expected time0 count following infusion  
11.5.1 Calculate blood volume:   
Male: BV (mL) = ([0.3669*{height (m)} 3] + 0.03219*weight (kg) + 
0.6041)*1000 
Female: BV (mL) = ([0.3561*{height (m)}3] + [0.03308*weight (kg)] + 
0.1833)*1000 
11.5.2 Convert the blood volume calculated in 11.5.1 to blood mass by 
multiplying the volume by the specific gravity of whole blood. The 
specific gravity may be taken as 1.05 g/mL, or, if the subject’s 
hematocrit is known, it may be estimated as (1541 + Hct)/1500 (Subject 
hematocrit is expressed as a percentage rather than a decimal; expected 
SG usually between 1.053 and 1.060 g/mL.). 
11.5.3 Determine expected time0 (t=0) count (Steps 11.3.2, 7.0, 11.5.2) 
Time0 Count = STDcorrected * Infusate mass (g) / Blood mass 
 
Determine recovery for each timed sample (optional) 
Take each fully adjusted sample count (11.4.2) and divide by the expected 
time0 count (11.5.3) to calculate the recovery at each sampling time: 
Recovery Time  t = Fully Adjusted Count Time  t / Time0 Count   
NOTE: The recovery result that is reported from the study is determined using 
the time0 extrapolation of the curve fitting program 
 
Kinetic curve fitting 
The fully adjusted timed-sample counts (Step 11.4.2) for times greater than 20 
hours are used for kinetic curve fitting and estimation of recovery and survival. 
That is, the 2 hour time sample is not used for kinetic curve fitting. These 
parameters may be estimated using a validated non-linear curve fitting routine 

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 
up to 7 Days 
 
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found in various statistical and pharmacokinetic computer program packages. 
The use of COST software, one of these software packages, is described below. 
Optionally, the recovery of timed-samples calculated in Step 11.6 may be used 
Recovery is determined as the extrapolated y-axis intercept (t=0) of the survival 
curve, expressed as the blood cell-bound activity in proportion to the expected 
activity as projected from the blood volume-based dilution 
The fully adjusted count data (CPM/g) for each timed sample point are entered 
into the COST program as y values, the time after infusion (in hours) as x 
values, and the expected time0 count. (Optionally, the recovery of each timed 
sample from 11.6 may be entered as y values.) 
11.7.1 Activate the COST program 
11.7.2 Select the appropriate group in COST into which the subject's data will 
be entered 
11.7.3 Enter the number of data points to be entered 
11.7.4 Enter the x- (time in hours) and y-values (fully adjusted timed sample 
count, Step 11.4.2) for each timed sample. Double check entry accuracy. 
(Optionally, enter the y value as recoveries from 11.6) 
11.7.5 Enter the time0 count from 11.5.3 into counts/milliliter field. (If the 
individual timed recoveries from 11.6 are used as y values, enter 100 
into the counts/milliliter field in COST to set the 100% recovery point) 
11.7.6 Perform data analyses using the multiple hit model 
11.7.7 If outliers are found, determine potential source of error and flag for 
review by medical director. Remove point from curve only if clearly a 
spurious result 
11.7.8 Save and print results. Append to unit records 
 
Completion of Records 
 
Complete, review and file all forms, data and other paperwork. 
 
Protocol Modifications for Variant 1 of BEST Version 4.2.1  
 
The protocol specific modifications for Variant 1 of the BEST 4.2.1 Method are 
listed in Table 16. These modifications are similar to those described about in 
Table 15   

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Title: A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival 
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Table 16 
Variant 1 of BEST Version 4.2.1 Method Modifications 
Section 
Variant 1 of BEST Version 4.2.1 Method 
Variant 1 of BEST Version 4.2.1 Method 
Modifications 
3.12 
111Indium Oxine in ethanol solution 
containing approximately 1 mCi per vial at 
the time of manufacturer’s calibration 
111Indium Oxine in ethanol solution 
containing approximately 1-2 mCi per vial at 
the time of manufacturer’s calibration 
3.13 
111Indium Oxine Labeling solution:  If not 
premixed, aseptically add 4.0 mL sterile 
ACD- A/saline solution to the vial of 
111Indium Oxine to make 5.0 mL of sterile 
111In-Oxine solution for labeling.  Mix well. 
(Stable for one week or until expiration of 
stock 111In oxine solution.) 
1 mCi 111Indium Oxine Labeling solution: If 
not premixed, aseptically add 4.0 mL sterile 
ACD- A/saline solution to the vial of 1mCi 
111Indium Oxine to make 5.0 mL of sterile 
111In-Oxine solution for labeling 
 
2mCi  111Indium Oxine Labeling solution: 
aseptically add 2mL Oxine Suspension 
buffer to the vial of 2mCi 111Indium Oxine to 
make 3mL 111Indium Oxine suspension. 
Aseptically mix approximately 83µL of the 
111Indium Oxine suspension with 1mL of 
ACD-A/Saline to create 50-60 µCi labeling 
solution.  
 
Mix well (Stable for one week or until 
expiration of stock 111In Oxine solution). 
4.1.2 
At the same time as 4.1.1, collect one 5 or 
7 mL blood sample from the subject into an 
EDTA tube. Mix well. Reserve for 
determination of radiolabel elution (see Step 
9.0) 
This tube can be taken here or during draw 
listed in Section 7.3 
4.2.2 
Using sterile technique, in a laminar flow 
hood, gently remove 10 mL from the stored 
platelet unit using a 20 mL syringe and 
16 ga needle  
Using sterile technique, in a laminar flow 
hood, gently remove two – 10mL from the 
stored platelet unit using sterilely docked 
transfer packs 
4.2.3 
Remove the needle and express the contents 
of the syringe into a 15 mL screw-cap 
conical labeled centrifuge tubes containing 
1.5 mL sterile ACD-A . Cap and mix gently 
by inversion 
Express the contents of the syringe into two 
– 15 or 50 mL screw-cap conical labeled 
centrifuge tubes each containing 1.5 mL 
sterile ACD-A (15% by volume, pH 4.5 – 
5.5).  Cap and mix gently by inversion or 
swirling 
4.3 
Centrifuge (hard spin) the ACD-PRP 
(FRESH SAMPLE) OR STORED 
PLATELET SAMPLE at 1500-2000 x g 
for 15 minutes at 20 to 24ºC with brake off  
Centrifuge (hard spin) the ACD-PRP 
(FRESH SAMPLE) OR STORED 
PLATELET SAMPLE at 1500-2000 x g for 
15 minutes at 20 to 24ºC with brake off   
4.4 
Remove the platelet-poor plasma (PPP) 
produced, as completely as possible and 
transfer to a new sterile conical tube. Spin 
PPP a second time (1500-2000 x g for 15 
Remove AND SAVE the supernatant, 
platelet-poor plasma (PPP) produced, as 
completely as possible and transfer to a new 
sterile conical tube. Spin PPP a second time 

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Section 
Variant 1 of BEST Version 4.2.1 Method 
Variant 1 of BEST Version 4.2.1 Method 
Modifications 
minutes with brake off), discard pellet and 
reserve supernatant PPP in a sterile tube for 
later use (Steps 4.6.2 and 4.6.5) 
(1500-2000 x g for 15 min with brake off or 
brake minimum to allow for addition of PPP 
to platelet sample within 20 minutes of 
platelet labeling (Section 4.6.1)), discard 
pellet and reserve supernatant PPP in a 
sterile tube for later use (Steps 4.6.2 and 
4.6.5) (this spin may be done during 
incubation mock radiolabel)  
4.6.3 
Centrifuge the tube at 1250 x g at 20 to 
24°C for 10 minutes with brake off. 
Centrifuge the tube at 1200 to 1250 x g at 20 
to 24°C for 10 minutes with brake off. 
4.5 
Using a sterile pipet, resuspend the 
harvested platelet pellet with 2 mL of ACD-
A/saline solution. Make sure a complete 
resuspension is achieved with no visible 
aggregates or clumps before starting 
radiolabeling. (Failure to obtain complete 
resuspension of platelets is a cause for 
discontinuation of the procedure.) 
Using a sterile pipet, resuspend the harvested 
platelet pellet with 2 mL of ACD-A/saline 
solution. Make sure a complete resuspension 
is achieved with no visible aggregates or 
clumps before starting radiolabeling. (Failure 
to obtain complete resuspension of platelets 
is a cause for discontinuation of the 
procedure.) 
 
Before proceeding to radiolabeling the 
platelets, one aliquot of Test platelets will 
be stopped and used only for in vitro 
analysis 
4.6.5 
Gently resuspend the platelet-pellet in 2 mL 
of STORED AUTOLOGOUS PLASMA 
PPP reserved previously (from Step 4.4). 
(Failure to obtain complete resuspension of 
platelets is a cause for discontinuation of the 
procedure.) After complete resuspension, 
add an additional 4 mL of STORED 
AUTOLOGOUS PLASMA PPP. 
Gently resuspend the platelet-pellet in 2 mL 
of PPP reserved previously (from Step 
4.4). (Failure to obtain complete 
resuspension of platelets is a cause for 
discontinuation of the procedure.) After 
complete resuspension, add an additional 
4 mL of PPP 
5.2.2 
Using sterile technique, in a laminar flow 
hood, gently remove 20 (± 2 mL) mL from 
the stored platelet unit using a 30 mL 
syringe and 16 ga needle   
Using sterile technique, in a laminar flow 
hood, gently remove two – 20mLfrom the 
stored platelet unit using sterilely docked 
transfer packs 
5.2.3 
Remove the needle and express 10 mL of 
the contents of the syringe into each of two 
15 mL screw-cap conical labeled centrifuge 
tubes each containing 1.5 mL sterile ACD-
A . Cap and mix gently by inversion 
Express 10 mL of the contents of the 
syringes into four - 50 mL screw-cap conical 
labeled centrifuge tubes each containing 1.5 
mL sterile ACD-A (15% by volume, pH 4.5 
– 5.5).  Cap and mix gently by inversion or 
swirling 
5.4 
Remove the platelet-poor plasma (PPP) 
produced, as completely as possible from 
both tubes and transfer to a new sterile 
conical tube. Spin PPP a second time 
Remove the platelet-poor plasma (PPP) 
produced, as completely as possible and 
transfer to a new sterile conical tube. Spin 
PPP a second time (1500–2000 x g for 15 

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Section 
Variant 1 of BEST Version 4.2.1 Method 
Variant 1 of BEST Version 4.2.1 Method 
Modifications 
(1500–2000 x g for 15 minutes at 20 to 
24ºC with brake off), discard pellet and 
reserve supernatant PPP in a sterile tube for 
later use (Steps 5.6.2 and 5.6.5). 
minutes at 20 to 24ºC with brake off) or 
brake minimum to allow for addition of PPP 
to platelet sample within 20 minutes of 
platelet labeling (Section 5.6.1), discard 
pellet and reserve supernatant PPP in a 
sterile tube for later use (Steps 5.6.2 and 
5.6.5) (this spin may be done during 
incubation mock radiolabel)  
5.5 
Resuspend the harvested platelet pellet in 
one tube with 3 mL of ACD-A/saline 
solution.  Using a sterile transfer pipette, 
transfer the resuspended platelets to the 
other tube containing the platelet pellet.  
Resuspend the second platelet button. Make 
sure a complete resuspension is achieved 
with no visible aggregates or clumps before 
starting the next step 
Resuspend the harvested platelet pellet in 
one tube with 3 mL of ACD-A/saline 
solution.  For Fresh platelets using a sterile 
transfer pipette, transfer the resuspended 
platelets to the other tube containing the 
platelet pellet and resuspend the second 
platelet button. Make sure a complete 
resuspension is achieved with no visible 
aggregates or clumps before starting the next 
step. 
 
Before proceeding to radiolabeling the 
platelets, one aliquot of Test platelets will 
be stopped and used only for in vitro 
analysis. 
5.6.2 
At the end of incubation, add 2.5 mL of 
ACD-A/saline and 0.5 mL STORED 
AUTOLOGOUS PLASMA of the reserved 
PPP (from Step 5.4) directly to the 
incubation tube containing the platelets in 
ACD-A/saline and Na251CrO4. 
At the end of incubation, add 2.5 mL of 
ACD-A/saline and 0.5 mL of the reserved 
PPP (from Step 5.4) directly to the 
incubation tube containing the platelets in 
ACD-A/saline and Na251CrO4 
5.6.3 
Centrifuge the tube at 1250 x g at 20 to 
24°C for 10 minutes with brake off. 
Centrifuge the tube at 1200 to 1250 x g at 20 
to 24°C for 10 minutes with brake off. 
5.6.5 
Gently resuspend the platelet-pellet in 2 mL 
of STORED AUTOLOGOUS PLASMA 
PPP reserved previously (from Step 5.4). 
(Failure to obtain complete resuspension of 
platelets is a cause for discontinuation of the 
procedure.) After complete resuspension, 
add an additional 4 mL of STORED 
AUTOLOGOUS PLASMA PPP. 
Gently resuspend the platelet-pellet in 2 mL 
of PPP reserved previously (from Step 
4.4). (Failure to obtain complete 
resuspension of platelets is a cause for 
discontinuation of the procedure.) After 
complete resuspension, add an additional 
4 mL of PPP. 
7.3 
Perform venipuncture with a 19-21 gauge 
butterfly infusion needle.  Draw one 10 mL 
EDTA (lavender-top) tube for the pre-
infusion sample 
Perform venipuncture with a 19 gauge 
butterfly infusion needle.  Draw one (or 2 if 
tube for elution was not drawn earlier) 
10 mL EDTA (lavender-top) tube for the 
pre-infusion sample 

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Section 
Variant 1 of BEST Version 4.2.1 Method 
Variant 1 of BEST Version 4.2.1 Method 
Modifications 
7.7 
Weigh empty infusion syringe, needle and 
needle cover.  Record weight on the data 
sheet.  Record the net weight of injectate 
Remove needle, cap syringe with syringe 
cap, and weigh syringe with syringe cap. 
Record weight on the data sheet.  Record the 
net weight of injectate 
8.1.2 
Optional: 2 hours after infusion. (Collect 
from the contralateral arm to that used for 
infusion.) 
Collect blood draw at 1and 2 hours after 
infusion. (Collect from the contralateral arm 
to that used for infusion.)  
8.1.3 
One sample daily between days 1 through 
day 7 (except weekends for samples after 
Day 1) and one final sample on day 10, 11 
or 12. (The last sample is called the 
“baseline” sample and is used to correct for 
inadvertent labeling of other blood 
components.) 
Sample on days 1, 2, 3, 4 (or 5 or 6), 7 (or 
8) and one final sample on day 10, 11 or 
12. (The last sample is called the “baseline” 
sample and is used to correct for inadvertent 
labeling of other blood components.) 
8.2.3 
Pipet approximately 2.0 mL of the mixed 
whole blood into the appropriate pre-
weighed tube using a positive displacement 
pipettor and replace cap 
This sample is prepared and counted 
duplicate 
9.3 – 9.6 
Pipet approximately 2 mL into a 12 x 75 
mm capped tube 
This sample is prepared and counted 
duplicate