A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant
Recruiting now · Not applicable
Conditions studied: Graft Vs Host Disease, Graft-versus-host-disease
In brief
Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.
Key facts
- Study ID
- NCT04337515
- Run by
- Christopher Dvorak
- People needed
- 90
- Starts
- 2019-12-19
- Expected to finish
- 2035-01-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female 0-30 years of age at time of transplant admission
- Documentation of a disease requiring HCT
- A donor (mismatched related or unrelated) must be located who are healthy and willing, and whom are able to donate bone marrow (BM) or peripheral blood stem cells (PBSC). Matched related donors may be used for patients with Fanconi Anemia.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
You may not qualify if…
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Presence of a healthy and willing HLA-identical related donor (except when the patient has Fanconi Anemia).
- Patient with an anticipated life expectancy of <1 month
- Patients with known hypersensitivity to murine (mouse) proteins or iron dextran
Where it is running
- University of California, San Francisco — San Francisco, California, United States (enrolling)
Full record on ClinicalTrials.gov
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