Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors

The purpose of this protocol is to characterize the performance of CaridianBCT's Spectra Optia Apheresis System, when used to collect mononuclear cells (MNCs) and cluster of differentiation 34 (CD34) positive cells from healthy nonmobilized blood donors and healthy G-CSF (granulocyte colony stimulating factor) mobilized blood donors, respectively.

Study Overview

• Status: Completed
• Conditions: Leukapheresis
• Intervention / Treatment: Device: Mononuclear cell collection.

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• United States
  • California
    • Emeryville, California, United States, 94608
      • Leukolab/Allcells
  • Tennessee
    • Memphis, Tennessee, United States, 38104-3401
      • Key Biologics
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Blood Center of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Community Volunteers

Description

Inclusion Criteria:

• Acceptable health history to allow blood product collection
• Weight >50<125 Kg (kilogram).
• Male or non-pregnant, non-nursing female.
• General good health, as determined by questionnaire.
• Normal prescreening complete blood count.
• Platelet count>150 x 10^3/uL (microliter) at initial screening and >120 x 10^3/uL immediately prior to leukapheresis.
• Adequate peripheral venous access to allow collection of product.
• Able to read, understand, and sign the informed consent form. Additional Inclusion Criteria for Mobilized Subjects
• If male, be willing to use a condom during sexual relations with a female partner until 48 hours following the last G-CSF injection.
• If female and of childbearing potential, be willing to use a medically acceptable contraceptive until 48 hours following the last G-CSF injection.

Exclusion Criteria:

• a) Collection or loss of:

  • more than a ½ pint (1 cup) of whole blood within the prior 56 days or,
  • more than 3 L (liter) of whole blood or 1.5 L of red blood cells within the prior 12 months or,
  • more than 12 L 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.
• Acute or symptomatic chronic lung disease.
• Active or chronic heart disease, including hypertension controlled by medication.
• History of hematologic malignancy or chronic hematologic disorder or bleeding disorder.
• Reactive test indicative of infection with T. pallidum, Human T-lymphotropic virus, HIV, Hepatitis C Virus, or Hepatitis B Virus (except isolated Hepatitis B Core Antibody Reactivity.
• Presence of psychological traits or physiological or medical conditions that would make subject unlikely to tolerate the procedures.
• Subjects taking prescription medications other than those deemed allowable by the investigator.
• Abnormal serum electrolytes or serum calcium levels.
• Abnormal serum creatinine level.
• Abnormal liver function results on ALT (alanine amino transferase) test.
• Abnormal coagulation testing on prothrombin time or partial thromboplastin time.
• Inadequate antecubital veins for leukapheresis or inability or unwillingness to tolerate leukapheresis.
• If female, pregnant or lactating. Additional Exclusion Criteria for Mobilized Subjects
• Received a G-CSF injection in the prior 4 months, or received more than twenty-five (25) doses of G-CSF (a dose includes several individual injections administered on one occasion).
• Known hypersensitivity to G-CSF or any E. coli-derived products.
• History of autoimmune condition or disorder, unless approved by principal investigator.
• Immediate family history (parents, grandparents, siblings, children) of hematologic malignancy.
• Active or history of iritis (anterior uveitis) or episcleritis.
• History of deep vein thrombosis or pulmonary embolism.
• Current treatment with lithium.
• Spleen tip palpable during physical exam.
• Positive SickleDex test.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-mobilized donors; In this arm the collection efficiency of mononuclear cells from non-mobilized donors will be studied.	Device: Mononuclear cell collection.; Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.
G-CSF mobilized donors; In this arm the collection efficiency of CD34+ cells will be studied.	Device: Mononuclear cell collection.; Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mononuclear Cell Collection Efficiency	The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.	One day
CD34+ Cell Collection Efficiency	The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected.	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet Collection Efficiency	Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.	One Day
Hematocrit of MNC Product	The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination.	One Day
Granulocyte % of MNC Product	Granulocyte contamination of the MNC product was quantitated as the percent of total product WBC (white blood cell) that were segmented granulocytes or bands.	One day
Viability of the Collected MNC Product	The viability of the collected white blood cells was assessed using the 7-AAD (7-amino actinomycin D) viability dye in a flow cytometric assay. Viability assessment is incorporated into the CD34 assay. This assay was only performed on G-CSF mobilized donors as nonmobilized donor have too few CD34+ cells to detect. Thus viability of the collected WBCs is reported only for the G-CSF mobilized arm.	One day

Collaborators and Investigators

• Sponsor: Terumo BCT
• Collaborators: Yale University; Versiti; Key Biologics, LLC; LeukoLab
• Investigators: Study Director: Jerome R Bill, MD, Terumo BCT

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: January 13, 2011
• First Submitted That Met QC Criteria: January 13, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): May 3, 2013
• Last Update Submitted That Met QC Criteria: May 2, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Leukapheresis; Hematopoetic Stem Cell Mobilization
• Other Study ID Numbers: BCT10-03