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

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.

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.