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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06337942
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bladder Transplantation — PROCEDURE
    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.
  • Combined Kidney and Bladder Transplantation — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Feb 1, 2025
Status verified
Feb 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
5 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bladder Transplantation
    Patients with terminal bladders who do not have kidney failure and who qualify for the study may undergo bladder transplantation.
  • Experimental: Combined Kidney and Bladder Transplantation
    Patients with terminal bladders who also have kidney failure and who qualify for the study may undergo combined kidney and bladder transplantation.

Primary Outcome Measure

Demonstrating the technical success of bladder or combined kidney-bladder transplantation [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095
Magdalena Mendez-Smith
[email protected]
310-267-7727
Nima Nassiri, MD (PRINCIPAL_INVESTIGATOR)

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