Clinical trial NCT01805180: Evaluation of the Spectra Optia PMN Cell Collection Procedure
Official title: A Controlled Evaluation of the Spectra Optia® Apheresis System's Granulocyte / Polymorphonuclear (PMN) Cell Collection Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Granulocyte/ Polymorphonuclear Cells
Lead sponsor: Terumo BCT
Sponsor class: INDUSTRY
First posted: 2013-03-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Acceptable health status and vital signs per the AABB blood donation guidelines to permit blood donation, including:

  1. Blood pressure ≥ 90/50 and ≤ 200/120 mmHg,
  2. Pulse \> 40 and \< 100 beats/min, and
  3. 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:

  1. WBC count in the range: 3,500-10,800/uL,
  2. Hematocrit in the range: 38-65%,
  3. Platelet count in the range: 150,000-400,000/uL,
  4. 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,
  5. Serum electrolyte concentrations: potassium in the range 3.6-5.1 mmol/L; calcium in the range 8.5-10.3 mg/dL,
  6. Serum creatinine not greater than 1.5mg/dL, and
  7. 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:

  1. more than 550mL of whole blood within the prior 56 days, or
  2. more than 3L of whole blood or 1.5L of red blood cells within the prior 12 months, or
  3. more than 12L of plasma within the prior 12 months, or
  4. a leukapheresis within the prior six weeks, or
  5. a plateletpheresis within the prior 48 hours or two within the prior 7 days or twenty-four within the last 12 months, or
  6. 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.

Primary outcomes:
measure: Granulocyte/PMN Cell Collection Efficiency
timeFrame: within 1 hour prior and within 5 minutes after each collection procedure
Secondary outcomes:
measure: Performance
timeFrame: within 1 hour prior and within 5 minutes after each collection procedure
measure: Characterization of Blood Product - PMN Cell Yield
timeFrame: within 5 minutes after each collection procedure
measure: Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed
timeFrame: within 5 minutes after each collection procedure
measure: Characterization of the Blood Product - PMN Cell Viability
timeFrame: within 5 minutes after collection procedure
measure: Characterization of the Blood Product - RBC Contamination
timeFrame: within 5 minutes after collection procedure
measure: Characterization of the Blood Product - Volume
timeFrame: within 5 minutes after collection procedure
measure: Usability/Assessment of System Operation - Time
timeFrame: Result captured immediately upon completion of procedure
measure: Usability/Assessment of System Operation - Adjustments
timeFrame: Adjustments known immediately upon completion of the procedure
measure: Usability/Assessment of System Operation - Device Malfunctions
timeFrame: Result know immediately upon successful completion of procedure
measure: Safety
timeFrame: 48-hours after last procedure
Other outcomes:
Locations:
city: Denver
country: United States
facility: Bonfils Blood Center
state: Colorado
city: Cincinnati
country: United States
facility: Hoxworth Blood Center
state: Ohio
city: Milwaukee
country: United States
facility: Blood Centers of Wisconsin
state: Wisconsin
Study officials:
affiliation: Terumo BCT
name: Raymond Goodrich, Ph.D
role: STUDY_DIRECTOR
References: