A Randomized, Crossover Trial to Characterize the Performance of the Spectra Optia Apheresis System Versus the COBE Spectra Apheresis System for Collection of Mononuclear Cells in Healthy Adult Donors
Overview
- Phase
- N/A
- Intervention
- Spectra Optia CMNC
- Conditions
- Healthy Apheresis Donors
- Sponsor
- Terumo BCT
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- CD34+ Collection Efficiency (CE1 %)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the last collection.
Detailed Description
This is a prospective, randomized, cross-over, multi-center study to evaluate the performance of the Spectra Optia system's CMNC Collection Procedure, compared to the COBE Spectra system's MNC Procedure in mobilized healthy donors. Up to 60 subject may be consented to meet the the enrollment target of 20 complete subjects. Eligible subjects will be randomized to receive either the Spectra Optia CMNC or the COBE Spectra MNC collection procedure first, followed by the opposite on the following day. Study participation will be up to 14 days: a 7-day screening period, four days for mobilization, one day for the first MNC collection with additional dose of mobilization, one day for the second MNC collection, and safety follow-up the following day. Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the second collection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥ 18 and ≤ 50 years of age
- •Healthy blood donor criteria as defined by the American Associate of Blood Banks (AABB)
- •a) Note: Subjects who are deferred from volunteer donations because of travel restrictions, piercings or tattoos may participate in the study
- •Adequate dual peripheral venous access
- •Acceptable prescreening laboratory results prior to MNC mobilization as specified below:
- •a) WBC 3,500 - 10,800/µL
- •b) Hematocrit 38% - 56%
- •c) Platelets 150,000 - 400,000/µL
- •d) Coagulation tests:
- •i. PT 9.0 - 13.0 seconds
Exclusion Criteria
- •Previous MNC collection failure
- •Known hypersensitivity or condition that prevents the use of anticoagulants
- •Known hypersensitivity or condition that prevents the use of G-CSF
- •Known hemoglobinopathy including sickle cell trait or disease
- •History of use in the past week or anticipated need for lithium
- •Concurrent enrollment in another clinical study that could impact the results or participation in this study
- •Active infection or any serious underlying medical condition that contraindicates apheresis
- •Women who are pregnant or lactating
- •Known history of significant head trauma
Arms & Interventions
Spectra Optia CMNC first, then COBE Spectra MNC
Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Intervention: Spectra Optia CMNC
Spectra Optia CMNC first, then COBE Spectra MNC
Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Intervention: COBE Spectra MNC
Spectra Optia CMNC first, then COBE Spectra MNC
Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Intervention: Granulocyte-colony stimulating factor (G-CSF)
COBE Spectra MNC first, then Spectra Optia CMNC
COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Intervention: Spectra Optia CMNC
COBE Spectra MNC first, then Spectra Optia CMNC
COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Intervention: COBE Spectra MNC
COBE Spectra MNC first, then Spectra Optia CMNC
COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Intervention: Granulocyte-colony stimulating factor (G-CSF)
Outcomes
Primary Outcomes
CD34+ Collection Efficiency (CE1 %)
Time Frame: within 5 minutes upon completion of procedure
The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. 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.
Secondary Outcomes
- CD34+ Per kg of Body Weight(within 5 minutes upon completion of procedure)
- MNC Blood Product Volume (mL)(within 5 minutes upon completion of procedure)
- MNC Product Contamination/Purity (%) - Hematocrit (%)(within 5 minutes upon completion of procedure)
- MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)(within 5 minutes upon completion of procedure)
- Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)(within 5 minutes upon completion of procedure)
- MNC Collection Efficiency (CE2%)(within 5 minutes upon completion of procedure)
- MNC Product Contamination/Purity - RBC Concentration (10^6/µL)(within 5 minutes upon completion of procedure)
- CD34+ Collection Efficiency (CE2 %)(within 5 minutes upon completion of procedure)
- MNC Collection Efficiency (CE1%)(within 5 minutes upon completion of procedure)
- MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)(within 5 minutes upon completion of procedure)
- MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)(within 5 minutes upon completion of procedure)
- Procedure Time (Minutes)(within 5 minutes upon completion of procedure)