Evaluation of the Spectra Optia PMN Cell Collection Procedure

Study Overview
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Brief Summary
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The purpose of this study is to compare the procedures for the collection PMN cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems.

Detailed Description
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The purpose of this study is to compare the procedures for the collection of granulocyte/ polymorphonuclear (PMN) cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems and to establish the non-inferiority of the Spectra Optia Apheresis System with respect to the primary study endpoint, granulocyte/PMN cell collection efficiency.

Official Title
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A Controlled Evaluation of the Spectra Optia® Apheresis System's Granulocyte / Polymorphonuclear (PMN) Cell Collection Procedure

Conditions
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Granulocyte/ Polymorphonuclear Cells

Intervention / Treatment
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* Device: Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System)
* Device: Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acceptable health status and vital signs per the AABB blood donation guidelines to permit blood donation, including: Blood pressure ≥ 90/50 and ≤ 200/120 mmHg, Pulse > 40 and < 100 beats/min, and Temperature < 99.5ºFahrenheit (F). Able to read, understand, and sign an English informed consent form. Age ≥ 18 years. Weight ≥ 50kg and < 227kg. Male or non-pregnant, non-nursing female (a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each mobilization). Acceptable screening laboratory test results prior to the first PMN cell mobilization, including: WBC count in the range: 3,500-10,800/uL, Hematocrit in the range: 38-65%, Platelet count in the range: 150,000-400,000/uL, Coagulation tests: PT not greater than 1.1 times the upper limit of the local laboratory reference range; PTT not greater than 1.2 times the upper limit of the local laboratory reference range, Serum electrolyte concentrations: potassium in the range 3.6-5.1 mmol/L; calcium in the range 8.5-10.3 mg/dL, Serum creatinine not greater than 1.5mg/dL, and ALT not greater than 1.5 times the upper limit of the local laboratory reference range. *** Up to two (2) of the above screening laboratory test results may fall outside of these ranges, if in the judgment of the principal investigator or designee, they do not constitute a significant risk to the subject. Any excused deviations from the above will be listed and summarized with the final report.*** Adequate dual peripheral venous access to allow collection of granulocytes (PMN cells) and return of remaining cells, platelets and plasma. If male, willing to use a condom during sexual relations with a female partner of child bearing potential until 48 hours following each G-CSF injection. If female, willing to use a medically-acceptable contraceptive until 48 hours following each G-CSF injection. Exclusion Criteria: Positive screening for any of the following: HIV, HBV (except isolated HB core Ab reactivity), HCV, HTLV, Syphilis or West Nile Virus. Currently pregnant or breast-feeding. Collection or loss of specific volumes of whole blood or blood components during specified timeframes: more than 550mL of whole blood within the prior 56 days, or more than 3L of whole blood or 1.5L of red blood cells within the prior 12 months, or more than 12L of plasma within the prior 12 months, or a leukapheresis within the prior six weeks, or a plateletpheresis within the prior 48 hours or two within the prior 7 days or twenty-four within the last 12 months, or a plasmapheresis within the prior 48 hours or two within the prior 7 days. History of congestive heart failure. History of uncontrolled hypertension (SBP/DBP >200/120 mmHg). History or suspicion of active, peptic ulcer disease. History of diabetes mellitus. History of hematologic malignancy or chronic hematologic disorder. Family history (parents, siblings, children) of hematologic malignancy. History of deep vein thrombosis or venous thromboembolism, or bleeding disorder. History of sickle cell disease or a positive SickleDex screen. History of iritis or episcleritis. History of autoimmune condition or disorder, unless approved by principal investigator. Presence of psychological traits, or physiological or medical conditions that, in the opinion of the investigator, would make the subject unlikely to tolerate the procedures or complete the study. History of use/anticipated need for lithium. Received a G-CSF injection in the prior 4 months. Known hypersensitivity to ethylene oxide. Known hypersensitivity to G-CSF or hypersensitivity to any E. coli-derived products. Known hypersensitivity to HES or corn. Concurrent participation in another clinical trial or participation in a clinical trial within the past 30 days. Subject is being treated with calcium channel blockers and/or antiepileptic medications. Note: This applies only to Subjects at Bonfils Blood Center whose collected product will undergo neutrophil function testing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1: Spectra Optia followed by COBE Spectra<br>Controlled evaluation of Granulocyte/Polymorphonuclear Cell Collection on the Spectra Optia device followed by the COBE Spectra device. | Device: Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System)<br>* In Arm 1 the first PMN cell collection will be performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System.<br>Device: Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)<br>* In Arm 2 the first PMN cell collection will be performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System.<br>|
| Other: Arm 2: COBE Spectra followed by Spectra Optia<br>Controlled evaluation of Granulocyte/Polymorphonuclear Cell Collection on the COBE Spectra device followed by Spectra Optia. | Device: Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System)<br>* In Arm 1 the first PMN cell collection will be performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System.<br>Device: Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)<br>* In Arm 2 the first PMN cell collection will be performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Granulocyte/PMN Cell Collection Efficiency | The primary endpoint is the granulocyte/PMN cell collection efficiency (CE) associated with the Granulocyte (PMN) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the PMN collection procedure. | within 1 hour prior and within 5 minutes after each collection procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | Comparison of collection efficiencies associated with the Granulocyte Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for white blood cells and platelets. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. | within 1 hour prior and within 5 minutes after each collection procedure | 
| Characterization of Blood Product - PMN Cell Yield | Characterization of the collected blood product, specifically total PMN cell yield. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product. | within 5 minutes after each collection procedure | 
| Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed | Characterization of the collected blood product, specifically PMN cell yield per liter blood processed. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product and blood processed measured by the device. | within 5 minutes after each collection procedure | 
| Characterization of the Blood Product - PMN Cell Viability | Characterization of the collected blood product, specifically PMN cell viability measured by an assay preformed on the collected blood product. | within 5 minutes after collection procedure | 
| Characterization of the Blood Product - RBC Contamination | Characterization of the collected blood product, specifically red blood cell (RBC) contamination as measured by hematocrit in the collected PMN product. | within 5 minutes after collection procedure | 
| Characterization of the Blood Product - Volume | Characterization of the collected blood product, specifically product volume. | within 5 minutes after collection procedure | 
| Usability/Assessment of System Operation - Time | Procedure time for collections on the Spectra Optia vs. the COBE Spectra. | Result captured immediately upon completion of procedure | 
| Usability/Assessment of System Operation - Adjustments | Number of operator adjustments aimed at establishing and maintaining the plasma/ cellular interface: namely, on Spectra Optia, the adjustment of collection preference and, on COBE Spectra, the adjustment of the plasma pump flow rate. | Adjustments known immediately upon completion of the procedure | 
| Usability/Assessment of System Operation - Device Malfunctions |  | Result know immediately upon successful completion of procedure | 
| Safety | Serious adverse events (SAEs) and unanticipated (serious) adverse device/procedure- related events (UADEs), adverse events (AEs). any clinically significant changes to Complete Blood Count with differential white cell count (CBCD) and any significant changes to vital signs (temperature, heart rate, blood pressure) were captured as AEs. Also provided in full report to FDA. | 48-hours after last procedure |