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An Evaluation of the Spectra Optia CMNC Collection Procedure

NCT02253160 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-09-24

Study results available
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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.

Conditions

  • Healthy Apheresis Donors
  • Mononuclear (MNC) Cell Donors

Interventions

DEVICE

Spectra Optia CMNC

The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.

DEVICE

COBE Spectra MNC

It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.

DRUG

Granulocyte-colony stimulating factor (G-CSF)

Each subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure.

Sponsors & Collaborators

  • Terumo BCT

    lead INDUSTRY

Principal Investigators

  • Raymond Goodrich, PhD · Terumo BCT

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-01-31
Completion
2015-01-31

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 NCT02253160 on ClinicalTrials.gov