Immune Reset Therapy Using Autologous Stem Cell Transplant to Enable Kidney Transplant in Highly Sensitized Patients with End-Stage Kidney Disease

What this Trial Is About

This trial investigates whether resetting the immune system can help highly sensitized patients with end-stage kidney disease safely receive a compatible kidney transplant. These patients have high antibody levels against donor organs, often due to previous transplants, pregnancies, or blood transfusions, making it very hard to find a matching donor and keeping them on dialysis long-term. The study aims to test a new approach using Autologous Hematopoietic Stem Cell Transplantation AHSCT to reduce these antibodies and improve transplant chances. Participants undergo a treatment involving intense immune cell depletion using medications including rituximab, cyclophosphamide adjusted for kidney disease, and thymoglobulin. After this conditioning, their own purified blood stem cells CD34 cells are collected and reinfused to rebuild the immune system. The process includes stem cell collection through leukapheresis followed by reinfusion, with a planned reactivation on the kidney transplant waiting list six months after AHSCT. The study has two phases initial safety testing with 4 patients followed by an efficacy and safety assessment with 6 more patients. Throughout the study, participants will be closely monitored for safety and immune system changes over 12 months. Blood and bone marrow samples will be collected to assess immune memory and antibody levels. Researchers will track changes in sensitization, successful kidney transplantation rates, and adverse events. Transplant recipients will receive standard immunosuppressive care. The trial duration includes a six-month wait before relisting for transplant and a full year of follow-up after AHSCT.

Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)