Using CliniMACS for 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
This study is testing if a special device can safely remove certain T-cells from donor blood to help patients getting a stem cell transplant avoid complications like graft-versus-host disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | N/A to 30 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04337515 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males or females aged 0-30 years requiring an allogeneic hematopoietic cell transplant with a willing and healthy donor.
Not a fit: Patients with a healthy and willing HLA-identical related donor or those with a life expectancy of less than one month may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of graft-versus-host disease in transplant patients, improving their overall outcomes.
How similar studies have performed: Other studies have shown promise in using similar approaches for T-cell depletion, but this specific application with the CliniMACS® device is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.