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

NCT01277549 | Completed Results

• 1 other identifier: BCT10-03
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Leukapheresis; Hematopoetic Stem Cell Mobilization

Outcome Measures

Primary Outcomes (2)

• Mononuclear Cell Collection Efficiency

  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.

  One day

• CD34+ Cell Collection Efficiency

  The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected.

  one day

Secondary Outcomes (4)

• Platelet Collection Efficiency

  One Day

• Hematocrit of MNC Product

  One Day

• Granulocyte % of MNC Product

  One day

• Viability of the Collected MNC Product

  One day

Study Arms (2)

Non-mobilized donors

In this arm the collection efficiency of mononuclear cells from non-mobilized donors will be studied.

Device: Mononuclear cell collection.

G-CSF mobilized donors

In this arm the collection efficiency of CD34+ cells will be studied.

Device: Mononuclear cell collection.

Interventions

Mononuclear cell collection. DEVICE

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

G-CSF mobilized donors; Non-mobilized donors

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Community Volunteers

You may qualify if:

• Acceptable health history to allow blood product collection
• Weight \>50\<125 Kg (kilogram).
• Male or non-pregnant, non-nursing female.
• General good health, as determined by questionnaire.
• Normal prescreening complete blood count.
• Platelet count\>150 x 10\^3/uL (microliter) at initial screening and \>120 x 10\^3/uL immediately prior to leukapheresis.
• Adequate peripheral venous access to allow collection of product.
• If male, be willing to use a condom during sexual relations with a female partner until 48 hours following the last G-CSF injection.
• If female and of childbearing potential, be willing to use a medically acceptable contraceptive until 48 hours following the last G-CSF injection.

You may not qualify if:

• a) Collection or loss of:
• more than a ½ pint (1 cup) of whole blood within the prior 56 days or,
• more than 3 L (liter) of whole blood or 1.5 L of red blood cells within the prior 12 months or,
• more than 12 L of plasma within the prior 12 months or,
• a leukapheresis within the prior six weeks or,
• a plateletpheresis within the prior 48 hours or two within the prior 7 days or twenty-four within the last 12 months or,
• a plasmapheresis within the prior 48 hours or two within the prior 7 days.
• Acute or symptomatic chronic lung disease.
• Active or chronic heart disease, including hypertension controlled by medication.
• History of hematologic malignancy or chronic hematologic disorder or bleeding disorder.
• Reactive test indicative of infection with T. pallidum, Human T-lymphotropic virus, HIV, Hepatitis C Virus, or Hepatitis B Virus (except isolated Hepatitis B Core Antibody Reactivity.
• Presence of psychological traits or physiological or medical conditions that would make subject unlikely to tolerate the procedures.
• Subjects taking prescription medications other than those deemed allowable by the investigator.
• Abnormal serum electrolytes or serum calcium levels.
• Abnormal serum creatinine level.

Sponsors & Collaborators

• Terumo BCT: lead
• Versiti Blood Health: collaborator
• Key Biologics, LLC: collaborator
• LeukoLab: collaborator
• Yale University: collaborator

Study Sites (3)

Leukolab/Allcells

Emeryville, California, 94608, United States

Location

Key Biologics

Memphis, Tennessee, 38104-3401, United States

Location

Blood Center of Wisconsin

Milwaukee, Wisconsin, 53233, United States

Location

Results Point of Contact

• Title: Jerome R Bill, M.D.
• Organization: Terumo BCT

jerry.bill@terumobct.com

303-231-4729

Study Officials

• Jerome R Bill, MD

  Terumo BCT

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 17, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 3, 2013
• Results First Posted: May 3, 2013

Record last verified: 2013-05

Locations

US (3)