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Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors

NCT01277549 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2013-05-03

Study results available
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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.

Conditions

  • Leukapheresis

Interventions

DEVICE

Mononuclear cell collection.

Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.

Sponsors & Collaborators

  • Versiti

    collaborator OTHER

  • Key Biologics, LLC

    collaborator INDUSTRY

  • LeukoLab

    collaborator UNKNOWN

  • Yale University

    collaborator OTHER

  • Terumo BCT

    lead INDUSTRY

Principal Investigators

  • Jerome R Bill, MD · Terumo BCT

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01277549 on ClinicalTrials.gov