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Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

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ClinicalTrials.gov Identifier: NCT00511550
Recruitment Status : Completed
First Posted : August 6, 2007
Last Update Posted : March 5, 2008
Sponsor:
Information provided by:
University of California, San Francisco

Brief Summary:
Peripheral blood stem cells (PBSCs) collected following stimulation with filgrastim are commonly used for autologous hematopoietic transplants. PBSCs are also now being used for some syngeneic and allogeneic hematopoietic transplants involving HLA-matched sibling donors. However, many issues remain unanswered about the use of PBSCs for allogeneic transplants and the effects of filgrastim on healthy individuals. The purpose of this study is to determine the effectiveness of filgrastim stimulated PBSCs in hematopoietic cell transplants involving unrelated donors and to determine the effects of this donation process on unrelated stem cell donors.

Condition or disease
Healthy

Detailed Description:
This study 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 study also describes procedures for the collection of PBSC products by leukapheresis and includes provisions for indefinite donor follow-up.

Study Type : Observational
Estimated Enrollment : 15 participants
Time Perspective: Prospective
Official Title: Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors
Study Start Date : August 2005
Estimated Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Healthy adults

Exclusion Criteria:

  • Pregnancy or uninterruptible breastfeeding.
  • Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
  • History of autoimmune disorders, including rheumatic disease and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable.
  • History of deep vein thrombosis or pulmonary embolism.
  • Thrombocytopenia <150 x 10(9)/L (<150,000/uL) at baseline evaluation.
  • Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been full evaluated.
  • Positive Hemoglobin-Solubility (e.g. SickleDex or equivalent) test.
  • Donors receiving experimental therapy or investigational agents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511550


Locations
United States, California
University of California San Francisco Medical Center
San Francisco, California, United States, 94143-0324
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Thomas G. Martin, M.D. University of California, San Francisco
Study Director: John Miller, M.D.,Ph.D. National Marrow Donor Program

ClinicalTrials.gov Identifier: NCT00511550     History of Changes
Obsolete Identifiers: NCT00005930
Other Study ID Numbers: UC-2508
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: March 5, 2008
Last Verified: July 2007

Keywords provided by University of California, San Francisco:
peripheral blood stem cells
filgrastim-mobilized
allogeneic transplantation
Unrelated Donors for allogeneic transplantation

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs