Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs

What this Trial Is About

This research aims to evaluate the combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance. The goal is to enable patients to completely stop immunosuppressive therapy without experiencing kidney rejection. This is a phase 2 interventional study focusing on this unique transplant approach for renal transplantation patients. The treatment involves collecting hematopoietic stem cells from the donor 4 to 8 weeks before the kidney transplant. CD34 cells are enriched and cryopreserved. After the kidney transplant, the recipient begins conditioning therapy including thymoglobuline, total lymphoid irradiation, steroids, tacrolimus, and mycophenolate mofetil. Eleven days post-transplant, the stem cell graft is thawed and infused into the recipient. If stable donor chimerism is maintained for over 6 months without rejection, immunosuppressive drugs may be gradually reduced until fully stopped. Participants will be closely monitored to assess kidney function and immune tolerance. The main outcome measured is the proportion of patients able to discontinue immunosuppression 12 months after transplant. Medical evaluations will include laboratory tests and clinical monitoring throughout the study to ensure safety and effectiveness. The total participation duration includes at least 12 months of follow-up after transplantation.

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction