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

NCT ID: NCT00511550

Last Updated: 2008-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2007-11-30

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.

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.

Conditions

Healthy

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Principal Investigators

Thomas G. Martin, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

John Miller, M.D.,Ph.D.

Role: STUDY_DIRECTOR

National Marrow Donor Program

Locations

University of California San Francisco Medical Center

San Francisco, California, United States

Countries

United States

Other Identifiers

UC-2508

Identifier Type: -

Identifier Source: org_study_id

NCT00005930

Identifier Type: -

Identifier Source: nct_alias