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A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant
A Feasibility Study of Using the CiniMacs® Device for Alpha/Best T-Cell Depletion in Stem Cell Transplant Recipients
Who can join
Up to age 30 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
About the study
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.
What is being tested
- CliniMacs® (device)
Sponsor: Christopher Dvorak · Participants: 90 · Started: Dec 19, 2019
Contact the study team
- Christopher C. Dvorak, MD · Phone: 415-476-0554
Official record on ClinicalTrials.gov — NCT04337515
Locations in the U.S.
| California | University of California, San Francisco, San Francisco |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.