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

Leukapheresis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277549
• Other study ID #: BCT10-03
• Status: Completed
• Phase: N/A
• First received: January 13, 2011
• Last updated: May 2, 2013
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: May 2013
• Source: Terumo BCT
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukapheresis

Intervention

Device:
• Mononuclear cell collection.
Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.

Locations

Country	Name	City	State
United States	Leukolab/Allcells	Emeryville	California
United States	Key Biologics	Memphis	Tennessee
United States	Blood Center of Wisconsin	Milwaukee	Wisconsin

Sponsors (5)

Lead Sponsor	Collaborator
Terumo BCT	Blood Center of Wisconsin, Key Biologics, LLC, LeukoLab, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Hematocrit of MNC Product	The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination.	One Day	No
Secondary	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	No
Secondary	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	No