NCT06337942 Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study

Trial Parameters

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Brief Summary

The goal of this clinical trial is to demonstrate the feasibility of bladder transplantation in patients with terminal bladder diseases who would benefit from a new bladder or a combined kidney and bladder transplant. The main questions it aims to answer are: * Is human bladder transplantation feasible and safe? * How will the new bladder function in terms of storage and emptying? Participants will undergo a bladder-only or combined kidney and bladder transplantation. They will then be followed for two years to evaluate the efficacy, safety, and functionality of the bladder transplant.

Eligibility Criteria

Inclusion Criteria: * Age 18-70 years * Positive history of one of the following: 1. Terminal bladder pathology resulting in poor compliance, recurrent refractory infections, and/or and resultant upper tract (kidney and ureteral) pathology, with possible resultant kidney disease. 2. Localized, non-metastatic, bladder cancer requiring radical cystectomy. In this protocol, the only patients with a history of urothelial cell carcinoma that has already been treated, with an appropriate disease-free interval would be considered. Moreover, only candidates requiring a joint kidney and bladder transplantation or patients with a pre-existing transplant, on standard immunosuppression, will be considered. * Patients that are on immunosuppression for pre-existing solid organ transplantation will be included in this study. * Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime. * Patient has been previously fully vaccinated and boosted against

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