Leukapheresis
Conditions
Keywords
Leukapheresis, Hematopoetic Stem Cell Mobilization
Brief 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.
Interventions
DEVICEMononuclear cell collection.
Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.
Sponsors
Versiti Blood Health
Key Biologics, LLC
LeukoLab
Yale University
Terumo BCT
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mononuclear Cell Collection Efficiency | One day | 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. |
| CD34+ Cell Collection Efficiency | one day | The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelet Collection Efficiency | One Day | Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected. |
| Hematocrit of MNC Product | One Day | The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination. |
| Granulocyte % of MNC Product | One day | Granulocyte contamination of the MNC product was quantitated as the percent of total product WBC (white blood cell) that were segmented granulocytes or bands. |
| Viability of the Collected MNC Product | One day | 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. |
Countries
United States
Participant flow
Recruitment details
Healthy adult donors were recruited at three blood collection centers to undergo a mononuclear cell collection using the experimental device, between January and September, 2011.
Participants by arm
| Arm | Count |
|---|---|
| G-CSF Mobilized Donors Donors received G-CSF prior to MNC collection | 15 |
| Nonmobilized Donors Donors not mobilized prior to MNC collection | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failed to meet eligibility criteria | 13 | 9 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 10 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | G-CSF Mobilized Donors | Nonmobilized Donors | Total |
|---|---|---|---|
| Age Continuous | 25 Years of Age | 33 Years of Age | 31 Years of Age |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 25 | 8 / 16 |
| serious Total, serious adverse events | 0 / 25 | 0 / 16 |
Outcome results
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.
Time frame: one day
Population: Results are given for all per protocol subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G-CSF Mobilized Donors | CD34+ Cell Collection Efficiency | 77 % of processed CD34+ cells collected |
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.
Time frame: One day
Population: Results are given for all per protocol subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G-CSF Mobilized Donors | Mononuclear Cell Collection Efficiency | 61 % of processed MNCs that were collected |
| Nonmobilized Donors | Mononuclear Cell Collection Efficiency | 57 % of processed MNCs that were collected |
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.
Time frame: One day
Population: Results given for all per protocol subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G-CSF Mobilized Donors | Granulocyte % of MNC Product | 15.0 percentage of WBCs collected |
| Nonmobilized Donors | Granulocyte % of MNC Product | 1.7 percentage of WBCs collected |
Secondary
Hematocrit of MNC Product
The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination.
Time frame: One Day
Population: Per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G-CSF Mobilized Donors | Hematocrit of MNC Product | 4.0 RBC % of product volume |
| Nonmobilized Donors | Hematocrit of MNC Product | 4.0 RBC % of product volume |
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.
Time frame: One Day
Population: Per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G-CSF Mobilized Donors | Platelet Collection Efficiency | 19 % of processed platelets collected |
| Nonmobilized Donors | Platelet Collection Efficiency | 12 % of processed platelets collected |
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.
Time frame: One day
Population: Per Protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G-CSF Mobilized Donors | Viability of the Collected MNC Product | 99 percentage of total WBCs collected |