RecruitingNot ApplicableNCT06337942

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

Vascularized Composite Bladder Allograft Transplantation: a Phase 0 (First-in-human) Study for Deceased Donor Bladder or Combined Kidney-bladder Transplantation

Sponsor

University of California, Los Angeles

Enrollment

5 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer Kidney Failure Bladder Disease Bladder, Neurogenic

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This is a first-of-its-kind study exploring bladder transplantation — either a bladder alone or a combined kidney-bladder transplant — from a deceased donor. It is a Phase 0 study, meaning it is the very first time this procedure is being tried in humans. **You may be eligible if...** - You are between 18 and 70 years old - You have severe bladder disease causing recurrent infections, poor bladder function, or damage to the kidneys, OR you have non-spreading bladder cancer requiring bladder removal - You are already on immunosuppression medications for a previous organ transplant - You are able and willing to perform or receive assistance with clean intermittent catheterization (a method of draining the bladder with a tube) - You are fully vaccinated against COVID-19 or willing to be vaccinated **You may NOT be eligible if...** - You have a serious medical condition that the study team believes would make participation too risky - You are unable or unwilling to follow the required medication and treatment plan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBladder Transplantation

A bladder transplantation will be performed. The bladder will be recovered from a brain-dead human donor. The connections that will be made will include connections between donor and recipient blood vessels, the bladder transplant and the recipient urethra, and the recipient's ureter(s) to the new bladder.

PROCEDURECombined Kidney and Bladder Transplantation

For patients who qualify for a combined kidney and bladder transplant, both a kidney and a bladder transplant will be performed. Both kidney and bladder allografts will be recovered from the same brain-dead human donor. The connections that will be made will include connections between donor and recipient blood vessels, the bladder transplant and the recipient urethra, and the kidney transplant ureter to the transplanted bladder. If the recipient has continued urine output, new connections between the native ureters and the transplanted bladder will also be made.