Using CliniMACS for T-Cell Depletion in Stem Cell Transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility of using the CliniMACS® device for ex vivo alpha-beta T-cell depletion in patients undergoing allogeneic hematopoietic cell transplant (HCT) to minimize the risk of graft-versus-host disease (GVHD). The CliniMACS® device utilizes a specific antibody to isolate hematopoietic stem cells from donor blood, enhancing the safety and efficacy of the transplant process. The study aims to gather data on the device's performance in a broader context than its current FDA-approved indications, which are limited to specific patient populations. Participants will be closely monitored for outcomes related to GVHD and overall transplant success.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Christopher C Dvorak, MD — Professor of Clinical Pediatrics
• Study coordinator: Christopher C. Dvorak, MD
• Email: christopher.dvorak@ucsf.edu
• Phone: 415-476-0554

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.