Stem Cell Infusion for Kidney Transplant Tolerance
Trial Summary
Will I have to stop taking my current medications?
The trial aims to see if participants can stop taking their immunosuppressive medications after receiving a stem cell infusion. However, the protocol does not specify if you need to stop other medications, so it's best to discuss this with the trial team.
What data supports the effectiveness of the treatment Hematopoietic Stem Cell Infusion for Kidney Transplant Tolerance?
Research shows that combining kidney and hematopoietic stem cell transplants from a matched donor can help the body accept the new kidney without needing lifelong medication to suppress the immune system. Studies have reported that this approach can promote immune tolerance, reducing the risk of organ rejection and other complications.12345
Is the infusion of donor-derived hematopoietic stem cells safe for kidney transplant patients?
How is the treatment Hematopoietic Stem Cell Infusion unique for kidney transplant patients?
Hematopoietic Stem Cell Infusion is unique because it aims to induce immune tolerance, potentially allowing kidney transplant patients to stop using immunosuppressive drugs. This treatment involves infusing stem cells from a donor to create a state of 'chimerism' (a mix of donor and recipient cells), which helps the body accept the new kidney without rejecting it.148910
What is the purpose of this trial?
The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG).
Research Team
Jeffrey Veale, MD
Principal Investigator
Professor of Urology
Eligibility Criteria
Adults over 18 with a well-functioning kidney transplant from an HLA-identical living donor can join. They must have good physical function, heart and liver health, no major post-transplant complications or rejection history, and stable kidney function. Women of childbearing age must use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Conditioning
Participants undergo a conditioning regimen with total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) to optimize engraftment
Hematopoietic Stem Cell Infusion
Infusion of hematopoietic stem cells from the HLA-identical donor
Weaning of Immunosuppression
Weaning of tacrolimus begins at 6 months with a goal of drug discontinuation within 12 months if conditions are met
Follow-up
Participants are monitored for safety and effectiveness after treatment, including graft function and chimerism measurement
Treatment Details
Interventions
- Hematopoietic Stem Cell Infusion
- Rabbit Anti-Thymocyte Globulin
- Total Lymphoid Irradiation
Hematopoietic Stem Cell Infusion is already approved in United States, European Union for the following indications:
- Induction of immune tolerance in kidney transplant recipients
- Treatment of various hematologic malignancies and nonmalignant diseases
- Induction of immune tolerance in organ transplant recipients
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor