Phase 0 Study on Deceased Donor Bladder or Combined Kidney-Bladder Transplantation to Test Safety and Function

What this Trial Is About

Researchers are evaluating the feasibility and safety of bladder transplantation in patients with terminal bladder diseases who may also need a combined kidney and bladder transplant. This Phase 0, first-in-human study aims to determine how well the transplanted bladder functions in terms of storing and emptying urine. The study focuses on patients with severe bladder conditions, including those with bladder cancer or kidney failure, to assess the potential of this new transplant approach. Participants will undergo either a bladder-only transplant or a combined kidney and bladder transplant using organs from brain-dead donors. The transplant procedure involves connecting donor blood vessels to the recipients vessels, attaching the transplanted bladder to the recipients urethra, and connecting the ureters appropriately. For combined transplants, the kidney and bladder are transplanted together with careful reconnections to ensure proper urine flow. The study includes a two-year follow-up period to monitor transplant success and function. During the study, participants will be closely monitored for the technical success of the transplant, immune rejection, adverse events, and bladder function over two years. Researchers will evaluate how well the new bladder stores and empties urine and assess safety outcomes. Participants must comply with the immunomodulatory treatment and follow-up visits, including demonstrating the ability to perform or receive assistance with clean intermittent catheterization. The study will provide important information on the viability of bladder transplantation as a new treatment option.

Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study