Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label
Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from NMDP donors.
Ongoing
Yes
John P Miller, MD, PhD
Principal Investigator
National Marrow Donor Program
United States: Food and Drug Administration
PBSC
NCT00785525
February 1997
January 2022
Name | Location |
---|---|
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Baylor University Medical Center | Dallas, Texas 75246 |
New York Blood Center | New York, New York 10021 |
Cook Children's Medical Center | Fort Worth, Texas 76104 |
Puget Sound Blood Center | Seattle, Washington 98014 |
Michigan Community Blood Centers | Grand Rapids, Michigan 49503 |
NMDP at Northern California & Northwest District | Oakland, California 94612 |
Blood Bank of San Bernardino & Riverside Cts. | San Bernadino, California 92408 |
San Diego Blood Bank | San Diego, California 92103 |
NMDP Southern California & Southwest District | Santa Ana, California 92705 |
Colorado Marrow Donor Program | Denver, Colorado 80230 |
NMDP Northeast District - New England Office | West Hartford, Connecticut 06110 |
NMDP Southeast District - Washington D.C. Office | Washington D.C., District of Columbia 20004 |
Gift of Life Bone Marrow Foundation | Boca Raton, Florida 33431 |
LifeSouth Community Blood Centers | Gainesville, Florida 32607 |
Community Blood Centers of So. Florida, Inc. | Lauderhill, Florida 33313 |
Florida's Blood Centers, Inc. | Orlando, Florida 32809 |
Florida Blood Services, Inc. | St. Petersburg, Florida 33716 |
Hawaii Bone Marrow Donor Registry | Honolulu, Hawaii 96817 |
LifeSource | Glenview, Illinois 60025 |
Rock River Valley Blood Center | Rockford, Illinois 61107 |
Community Blood Services of Illinois | Urbana, Illinois 61801 |
Indiana Blood Center | Indianapolis, Indiana 46208 |
Iowa Marrow Donor Program | Iowa City, Iowa 52242 |
NMDP Southcentral District, Heart of America Donor Center | Leawood, Kansas 66206 |
NIH Marrow Donor Center | Rockville, Maryland 20892 |
C.W. Bill Young Marrow Donor Center | Rockville, Maryland 20852 |
Dana Farber/Partners Cancer Care | Boston, Massachusetts 02115 |
The Caitlin Raymond International Registry | Worcester, Massachusetts 01655 |
NMDP Northcentral District - Michigan Office | East Lansing, Michigan 48823 |
NMDP Northcentral District - Minnesota Office | Minneapolis, Minnesota 55413 |
Mississippi Marrow Donor Program | Jackson, Mississippi 39216 |
The HLA Registry | Oradell, New Jersey 07649 |
DKMS Americas | New York, New York 10016 |
NMDP Northeast District - Greater NY State Office | Rochester, New York 14607 |
NMDP Southeast District | Charlotte, North Carolina 28269 |
NMDP Northcentral District | Cleveland, Ohio 44131 |
Community Blood Center | Dayton, Ohio 45402 |
Sylvan N. Goldman Center, Oklahoma Blood Institute | Oklahoma City, Oklahoma 73104 |
NMDP Northern California & Northwest District - Oregon Office | Portland, Oregon 97210 |
NMDP Northeast District | Philadelphia, Pennsylvania 19123 |
Central Blood Bank | Pittsburgh, Pennsylvania 15220 |
Rhode Island Blood Center | Providence, Rhode Island 02908 |
Blood Assurance, Inc. | Chattanooga, Tennessee 37403 |
Cooperative Appalachian Marrow Program | Johnson City, Tennessee 37604 |
Carter BloodCare | Bedford, Texas 76021 |
Gulf Coast Regional Blood Center | Houston, Texas 77054 |
South Texas Blood and Tissue Center | San Antonio, Texas 78201 |
Scott & White Clinic | Temple, Texas 76508 |
NMDP Southeast District - Virginia Office | Richmond, Virginia 23229 |
Inland Northwest Blood Center | Spokane, Washington 99201 |
Community Blood Center, Inc. | Appleton, Wisconsin 54914 |
The Blood Center of Wisconsin | Milwaukee, Wisconsin 53233 |