CliniMACS® T-Cell Depletion for Stem Cell Transplant Patients
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the CliniMACS® T-Cell Depletion treatment for stem cell transplant patients?
Research shows that the CliniMACS system effectively purifies and recovers CD34+ cells (important stem cells) while efficiently removing T cells, which can help reduce complications in stem cell transplants. This method has been used successfully in both children and adults with severe blood disorders and autoimmune diseases, showing higher purity and recovery rates compared to other methods.12345
Is CliniMACS® T-Cell Depletion safe for humans?
The CliniMACS® system, used for T-cell depletion in stem cell transplants, has shown consistent safety in studies, with no endotoxins (harmful substances) detected and negative results for bacterial contamination. It has been used successfully in both children and adults for various conditions, indicating a generally safe profile.12356
How is the CliniMACS® treatment different from other treatments for stem cell transplant patients?
The CliniMACS® treatment is unique because it uses a magnetic separation technique to efficiently deplete T cells from stem cell grafts, resulting in higher purity and recovery of CD34+ cells compared to other methods. This approach helps reduce the risk of complications like graft-versus-host disease in stem cell transplants.12357
Research Team
Christopher C Dvorak, MD
Principal Investigator
Professor of Clinical Pediatrics
Eligibility Criteria
This trial is for males and females aged 0-30 needing a stem cell transplant due to certain diseases, with donors available who can give bone marrow or blood stem cells. It's not for those with identical related donors (unless they have Fanconi Anemia), life expectancy under one month, mouse protein or iron dextran allergies, pregnant/breastfeeding individuals, or if birth control isn't used.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive alpha-beta T-cell depleted stem cell transplants using the CliniMACS system
Follow-up
Participants are monitored for safety and effectiveness after treatment, including engraftment and GVHD evaluations
Long-term follow-up
Participants are monitored for long-term outcomes such as transplant-related mortality and chronic GVHD
Treatment Details
Interventions
- CliniMACS®
CliniMACS® is already approved in United States, European Union for the following indications:
- Prevention of graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) in first complete remission undergoing allogeneic hematopoietic cell transplant from a matched related donor
- Available as CE-marked medical devices for various cell separation and processing applications, but specific indications are not detailed beyond general use for hematopoietic cell processing
Find a Clinic Near You
Who Is Running the Clinical Trial?
Christopher Dvorak
Lead Sponsor