Collecting stem cells from healthy unrelated donors using filgrastim

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to establish a system for collecting filgrastim-mobilized peripheral blood stem cells (PBSC) from unrelated donors registered with the National Marrow Donor Program. It evaluates the safety of filgrastim administration and the leukapheresis process among these donors, as well as the safety and efficacy of the collected PBSC in transplant recipients. The study also seeks to determine how acceptable the donation process is for healthy individuals. By leveraging a large donor registry, the study hopes to enhance the availability of stem cells for transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in the Donor Center Manual of Operations.
2. Confirmatory pregnancy test must be performed within 15 days of collection and prior to the start of filgrastim administration; this may require more than one test to be performed.

Exclusion Criteria:

1. Pregnancy or uninterruptible breastfeeding. Pregnancy is an absolute contraindication under this protocol. Women who are breastfeeding must be willing and able to interrupt breastfeeding during the administration of filgrastim and for two days following the final dose.
2. Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
3. History of autoimmune disorders, including rheumatic diseases and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable.
4. History of deep vein thrombosis or pulmonary embolism.
5. History of iritis or episcleritis.
6. Thrombocytopenia \< 150 x 10\^9/L (\< 150,000/uL) at baseline evaluation.
7. Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated.
8. Positive Hemoglobin-Solubility (e.g., SickleDex or equivalent) test.
9. Donors receiving experimental therapy or investigational agents.
10. Positive pregnancy test collected/reported prior to start of filgrastim.

Where it's running

• Gift of Life Bone Marrow Foundation
  Boca Raton, Florida, United States Recruiting
• C.W. Bill Young Marrow Donor Center
  Rockville, Maryland, United States Recruiting
• Be The Match
  Minneapolis, Minnesota, United States Recruiting
• DKMS Americas
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: John P Miller, MD, PhD — National Marrow Donor Program
• Study coordinator: Lisa Erickson
• Email: PBSCStudyTeam@nmdp.org

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.