Bladder or Combined Kidney-Bladder Transplants for Bladder Disease
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on immunosuppression for a pre-existing organ transplant, you will continue with that treatment.
What data supports the effectiveness of this treatment for bladder disease?
Is bladder or combined kidney-bladder transplantation safe in humans?
How is the treatment of bladder or combined kidney-bladder transplants unique for bladder disease?
This treatment is unique because it involves transplanting a whole bladder or a combined kidney and bladder from a deceased donor, which has never been done in humans before. It aims to address complex bladder diseases by replacing the entire organ, unlike other treatments that may only reconstruct or augment the existing bladder.12567
What is the purpose of this trial?
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
This trial is for individuals with severe bladder conditions or kidney failure who might benefit from a new bladder or both a new bladder and kidney. Participants should be in need of these transplants due to terminal diseases affecting these organs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Transplantation
Participants undergo bladder-only or combined kidney and bladder transplantation
Initial Follow-up
Participants are monitored for immediate peri-operative, 30, and 90-day adverse profiles
Long-term Follow-up
Participants are monitored for efficacy, safety, and functionality of the bladder transplant
Treatment Details
Interventions
- Bladder Transplantation
- Combined Kidney and Bladder Transplantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor