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CompletedNCT00511550Updated Mar 5, 2008

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

An observational study in Healthy, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-03-05.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
15
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • peripheral blood stem cells
  • filgrastim-mobilized
  • allogeneic transplantation
  • Unrelated Donors for allogeneic transplantation
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

-Healthy adults

Exclusion criteria

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.
05

Study design

Time perspective
Prospective
Enrollment
15 participants
06

Study locations

1 site
  • University of California San Francisco Medical Center
    San Francisco, California 94143-0324, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00511550
Lead sponsor
University of California, San Francisco
First posted
Aug 6, 2007
Start date
Aug 2005
Completion
Nov 2007
Last update
Mar 5, 2008

Study contacts

Thomas G. Martin, M.D.
principal investigator · University of California, San Francisco
John Miller, M.D.,Ph.D.
study director · National Marrow Donor Program

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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