Collecting stem cells from healthy unrelated donors using filgrastim

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

This study is testing a way to safely collect stem cells from healthy volunteers using a medication called filgrastim to see if it can help make more stem cells available for people needing transplants.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60000 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Center for International Blood and Marrow Transplant Research (Research network)
• Locations: 4 sites (Boca Raton, Florida and 3 other locations)
• Trial ID: NCT00785525 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy individuals who are willing to donate stem cells and meet the eligibility criteria set by the National Marrow Donor Program.

Not a fit: Patients who are pregnant, breastfeeding, or have certain medical histories such as autoimmune disorders or previous thromboembolic events may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the safety and efficacy of stem cell transplants from unrelated donors, potentially saving more lives.

How similar studies have performed: Previous studies have shown success in using filgrastim for mobilizing stem cells, making this approach well-supported by existing evidence.

Eligibility criteria

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 this trial is running

Boca Raton, Florida and 3 other locations

• 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

Conditions Healthy; Healthy Unrelated Stem Cell Donors