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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00511550

Enrollment

Registered

2007-08-06

Start date

2005-08-31

Completion date

2007-11-30

Last updated

2008-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Countries

United States

Outcome results