A Phase I Feasibility Study of HSPC Infusion Following Total Lymphoid Irradiation and Anti-thymocyte Globulin in Patients With a Pre-existing, Well-functioning HLA-matched Living-donor Liver Transplant to Induce Immune Tolerance.
University of California, Los Angeles
Summary
This clinical trial is being conducted to help liver transplant recipients safely discontinue toxic immunosuppressive drugs years after surgery. Lifelong use of these drugs is the current standard, but they come with life-threatening side effects. UCLA has pioneered this "Delayed Tolerance" approach, achieving success in numerous kidney recipients now living drug-free. The process uses a conditioning regimen followed by donor stem cell infusion to retrain the immune system to accept the liver as "self."
Description
This study seeks to determine if patients with a pre-existing, well-functioning liver transplant from an HLA-matched living donor can be withdrawn from maintenance immunosuppressive medications without compromising allograft function through hematopoietic stem and progenitor cell (HSPC) infusion from the same donor. HSPC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG) that takes course over two weeks, with HSPC infusion being on the final day. This entire protocol will take place in the outpatient setting. At se…