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Deceased Donor Bladder or Combined Kidney-bladder Transplantation Study

This study is looking at whether bladder transplantation, or a combined kidney and bladder transplantation, is safe and works well for people with serious bladder problems. These problems could be from conditions that damage the bladder or from bladder cancer requiring surgery. Researchers want to see if a new bladder, taken from a deceased donor, can function properly. You could be eligible if you are between 18 and 70 years old and have certain bladder conditions. The main goal is to see if these transplant procedures are technically successful after two years. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 5 participants. It is a first-in-human study, meaning it's the first time this procedure is being tested in people.
What's involved
Participants will undergo either a bladder transplantation or a combined kidney and bladder transplantation. They will then be followed for two years to check how well the new bladder is working and for safety.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years after their transplant to evaluate the efficacy, safety, and functionality of the new bladder.

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NCT06337942

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

Recruiting
NAAges 18–70InterventionalTreatment
University of California, Los Angeles
~5 participants
Updated 2025-02-12 on ClinicalTrials.gov
What's tested:Bladder TransplantationCombined Kidney and Bladder Transplantation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demonstrating the technical success of bladder or combined kidney-bladder transplantation
Measured over 2 years

Conditions

Bladder Disease
Bladder, Neurogenic
Bladder Cancer
Kidney Failure

Explore related trials

Bladder CarcinomaBladder DisorderRenal Failure

Where it's being run

1 sites across 1 states
California1

Who to contact

Dana Lopez, MPH
[email protected]
310-794-8893
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18-70 years
Positive history of one of the following:
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 COVID-19, or is willing to undergo timely vaccination.
Patients must demonstrate appropriate manual dexterity or sufficient assistance at home to perform clean intermittent catheterizations as needed. The patient (or assistant) must demonstrate proficiency in performing clean intermittent catheterization during pre-transplant workup.
No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of genitourinary transplantation. Examples of such medical conditions would include burden of atherosclerotic disease that would preclude vascular anastomosis, and psychiatric disorders that would preclude reliable adherence to medications.
No active co-existing psychosocial problems (i.e., alcoholism, drug abuse).
Negative crossmatch with donor.

Exclusion

Positive history of one of the following medical co-morbidities:
Patient is either not vaccinated or is unwilling to undergo vaccination against COVID-19 prior to transplantation.
Oncology patient specific:
Patients unable to receive adequate follow-up care and/or unable to receive immunosuppression due to geographic, financial or other reasons.
Patients with a smoking history who cannot demonstrate smoking cessation for a period of 6 months prior to listing and a desire to abstain from post-operative smoking will be excluded.
Records of poor medical compliance, documented psychological disorder(s), substance abuse or incomplete psychological clearance.
Particular attention will be paid to the candidate's compliance and their desire to undergo the offered procedure. While there is no "score" on any particular evaluation that would rule out a patient, certain factors can aid in the identification of patients who for example may not have the ability to comply with the medical directives necessary to care for a genitourinary transplant, or psychologically are not prepared for transplant, or who have unrealistic expectations about the transplant. The decision on eligibility is a team decision. All members of the team will discuss each candidate in a multidisciplinary meeting and reasons for concern over eligibility will be discussed at a Selection Committee Meeting. In circumstances where the candidate is considered to be less suitable, they could be given an opportunity to address these issues either through individual counseling or further education and then be reconsidered as a potential candidate. Every effort to prevent a request for allograft removal will be made.

What this trial measures

  • Demonstrating the technical success of bladder or combined kidney-bladder transplantation2 years

    The technical success of bladder transplantation will be evaluated. Technical success is defined as sustained and adequate perfusion to the bladder to maintain viability, as assessed through cystoscopic visual inspection and imaging, including ultrasound and cross-sectional imaging.