NCT06337942

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Disease
• Bladder, Neurogenic
• Bladder Cancer
• Kidney Failure

Interventions

Type	Name	Description
PROCEDURE	Bladder 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.
PROCEDURE	Combined 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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2024-03-29
• Last updated: 2025-02-12

Locations

1 site across 1 country: United States