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RecruitingGraft Vs Host DiseaseGraft-versus-host-disease

A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant

Eligible age

Up to 30 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this 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.

Sponsor: Christopher Dvorak

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's recruiting

California

San Francisco

Source: ClinicalTrials.gov · NCT04337515 · last updated 2026-04-13

A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion i · TrialPath