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NCT02253160 · ClinicalTrials.gov registry record · NA
An Evaluation of the Spectra Optia CMNC Collection Procedure
A NA study of Healthy Apheresis Donors and Mononuclear (MNC) Cell Donors, sponsored by Terumo BCT.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
- 2
- Study locations
NCT02253160: Completed NA study of Healthy Apheresis Donors and Mononuclear (MNC) Cell Donors, sponsored by Terumo BCT.
NCT02253160 is a NA study of Healthy Apheresis Donors and Mononuclear (MNC) Cell Donors that has completed, run by Terumo BCT. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02253160, a NA study of Healthy Apheresis Donors and Mononuclear (MNC) Cell Donors, has completed, sponsored by Terumo BCT.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Spectra Optia CMNC
- DEVICE COBE Spectra MNC
- DRUG Granulocyte-colony stimulating factor (G-CSF)
Study Locations (2)
Ohio
- Hoxworth Blood Center - Cincinnati
Tennessee
- Key Biologics, LLC - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-09 |
| Est. Completion | 2015-01 |
| Phase | NA |
What the finished NCT02253160 record still lists
NCT02253160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Healthy Apheresis Donors appearing as the primary indexed condition, and to 3 interventions - of which Spectra Optia CMNC is the first listed.
NCT02253160 reports a single indexed study location in Ohio, Tennessee.
Frequently Asked Questions
What is clinical trial NCT02253160 about?
NCT02253160 is a clinical study titled "An Evaluation of the Spectra Optia CMNC Collection Procedure". 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 be...
What is the current status of trial NCT02253160?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2014-09. Estimated completion is 2015-01.
What conditions does trial NCT02253160 study?
This clinical trial studies the following conditions: Healthy Apheresis Donors, Mononuclear (MNC) Cell Donors.
What interventions are being tested in trial NCT02253160?
The interventions under investigation include: Spectra Optia CMNC (DEVICE), COBE Spectra MNC (DEVICE), Granulocyte-colony stimulating factor (G-CSF) (DRUG).
Who is sponsoring clinical trial NCT02253160?
This trial is sponsored by Terumo BCT, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02253160 being conducted?
This trial has 2 study locations across Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02253160's enrollment target sits among peer trials
23 1755th of 2000 higher than 245 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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