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 Type
OBSERVATIONAL
Enrollment
71
Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.
Leukolab/Allcells
Emeryville, California, United States
Key Biologics
Memphis, Tennessee, United States
Blood Center of Wisconsin
Milwaukee, Wisconsin, United States
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.
Time frame: 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.
Time frame: one day
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.
Time frame: One Day
Hematocrit of MNC Product
The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination.
Time frame: 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.
Time frame: 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.
Time frame: One day
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