Last updated on June 2019

Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Brief description of study

The purpose of the study is to:

  • Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from National Marrow Donor Program donors (NMDP) donors
  • Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis
  • Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients
  • Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors

Detailed Study Description

For many years, allogeneic bone marrow transplantation has been used to successfully treat leukemias, other hematologic conditions and congenital disorders. The first unrelated donor transplants were performed in the late 1970s, but this procedure did not become widely available until the development of several consolidated unrelated donor registries around the world. The National Marrow Donor Program, established in 1987, is the world's largest registry and currently lists more than 7 million donors. Since its beginning, NMDP has facilitated more than 30,000 unrelated transplants.

Although not a licensed indication, considerable experience has been accumulated concerning administration of filgrastim to normal adults. Most of these adults were volunteer research subjects or donors of PBSC for use in related donor transplants. Beginning in February 1997, filgrastim stimulated PBSC have been collected from NMDP donors under protocol. The protocol (locally referred to as G2) began under an NMDP-sponsored Investigational New Drug (IND) application filed with FDA for collecting PBSC for a second donation following an initial donation of bone marrow. In 1999 a second protocol was opened (locally referred to as G1) as requests for PBSC as a primary donation source became more common. In 2005 the two protocols were combined to eliminate redundancy and provide for ease of use.

The protocol establishes and evaluates a system to supply peripheral blood stem cell (PBSC) products for use in unrelated donor hematopoietic stem cell (HSC) transplantation. The protocol describes processes for donor identification, education and evaluation. Procedures for administration and monitoring of the stem cell mobilizing agent filgrastim are included. The protocol also describes procedures for the collection of PBSC products by leukapheresis and includes provisions for long term donor follow-up.

Clinical Study Identifier: NCT00785525

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San Diego Blood Bank

San Diego, CA United States
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LifeSouth Community Blood Centers

Gainesville, FL United States
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Florida Blood Services, Inc.

Saint Petersburg, FL United States
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Glenview, IL United States
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Indiana Blood Center

Indianapolis, IN United States
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Iowa Marrow Donor Program

Iowa City, IA United States
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NIH Marrow Donor Center

Rockville, MD United States
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Michigan Community Blood Centers

Grand Rapids, MI United States
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The HLA Registry

Oradell, NJ United States
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New York Blood Center

Brooklyn, NY United States
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DKMS Americas

New York, NY United States
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NMDP Southeast District

Charlotte, NC United States
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NMDP Northcentral District

Cleveland, OH United States
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Community Blood Center

Dayton, OH United States
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NMDP Northeast District

Philadelphia, PA United States
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Central Blood Bank

Pittsburgh, PA United States
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Rhode Island Blood Center

Providence, RI United States
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Blood Assurance, Inc.

Chattanooga, TN United States
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Carter BloodCare

Bedford, TX United States
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Cook Children's Medical Center

Fort Worth, TX United States
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Scott & White Clinic

Temple, TX United States
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Puget Sound Blood Center

Seattle, WA United States
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Community Blood Center, Inc.

Appleton, WI United States
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The Blood Center of Wisconsin

Milwaukee, WI United States
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NMDP at Puerto Rico

Guaynabo, Puerto Rico
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Recruitment Status: Open

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