Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Launched by CENTER FOR INTERNATIONAL BLOOD AND MARROW TRANSPLANT RESEARCH · Nov 4, 2008

Keywords

ClinConnect Summary

This clinical trial is studying the use of stem cells collected from healthy donors to help patients who need a stem cell transplant. Specifically, it looks at a method for collecting these stem cells after the donor has received a medication called filgrastim, which helps boost the number of stem cells in the blood. The trial aims to ensure that this process is safe for donors and effective for patients receiving the stem cell transplants. Researchers also want to understand how acceptable this type of donation is for healthy individuals.

To participate in this trial, donors must be between 18 and 75 years old and meet certain health criteria set by the National Marrow Donor Program. For example, women must not be pregnant and need to take a pregnancy test before starting the process. Donors will receive filgrastim and undergo a procedure to collect their stem cells, which is generally safe and done in a medical setting. The trial is currently recruiting participants, and those interested in helping patients may find it a rewarding opportunity. If you have any further questions or want more details, discussing it with your doctor could be a great next step!

Gender

ALL

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.