Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-09 @ 12:22 PM
Study NCT ID:
NCT02253160
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Evaluation of the Spectra Optia CMNC Collection Procedure
Sponsor:
Terumo BCT
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CMNC
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: