First Human Bladder Transplant.
Aakash M Shah
https://pubmed.ncbi.nlm.nih.gov/40503649Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06337942
Vascularized Composite Bladder Allograft Transplantation: a Phase 0 (First-in-human) Study for Deceased Donor Bladder or Combined Kidney-bladder Transplantation
Led by University of California, Los Angeles · Updated on 2025-02-12
5
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of bladder transplantation in patients with terminal bladder diseases who may also need a combined kidney and bladder transplant. This Phase 0, first-in-human study aims to determine how well the transplanted bladder functions in terms of storing and emptying urine. The study focuses on patients with severe bladder conditions, including those with bladder cancer or kidney failure, to assess the potential of this new transplant approach. Participants will undergo either a bladder-only transplant or a combined kidney and bladder transplant using organs from brain-dead donors. The transplant procedure involves connecting donor blood vessels to the recipient's vessels, attaching the transplanted bladder to the recipient's urethra, and connecting the ureters appropriately. For combined transplants, the kidney and bladder are transplanted together with careful reconnections to ensure proper urine flow. The study includes a two-year follow-up period to monitor transplant success and function. During the study, participants will be closely monitored for the technical success of the transplant, immune rejection, adverse events, and bladder function over two years. Researchers will evaluate how well the new bladder stores and empties urine and assess safety outcomes. Participants must comply with the immunomodulatory treatment and follow-up visits, including demonstrating the ability to perform or receive assistance with clean intermittent catheterization. The study will provide important information on the viability of bladder transplantation as a new treatment option.
CONDITIONS
Brief Title
Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18-70 years
- History of terminal bladder disease causing poor bladder compliance, recurrent infections, or upper tract damage
- Localized, non-metastatic bladder cancer requiring radical cystectomy with disease-free interval if urothelial cell carcinoma
- Candidates for bladder-only or combined kidney and bladder transplantation
- Patients on immunosuppression for a pre-existing transplant
- Agreement to follow the immunomodulatory treatment plan
- Fully vaccinated and boosted against COVID-19, or willing to be vaccinated
- Ability or assistance to perform clean intermittent catheterization
- No medical condition affecting treatment or surgery risks as judged by the study team
- No active psychosocial problems such as alcoholism or drug abuse
- Negative crossmatch with donor
You will not qualify if you...
- HIV infection, active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, toxoplasmosis, or varicella zoster virus
- Blood disorders like hemophilia, Von-Willebrand's disease, protein C and S deficiency, thrombocythemia, thalassemia, sickle cell disease
- Mixed connective tissue diseases and collagen disorders including severe rheumatoid arthritis and Ehlers-Danlos syndrome
- Lipopolysaccharidosis or amyloidosis
- Impaired liver function or secondary coagulopathy
- Severe anemia, leukopenia, or thrombocytopenia below specified thresholds
- Not vaccinated or unwilling to vaccinate against COVID-19
- History of non-urothelial cancer in past 5 years except non-melanomatous skin cancer
- History of metastatic cancer
- Unable to receive adequate follow-up or immunosuppression due to geographic or financial reasons
- Smoking history without cessation for 6 months prior to listing and unwillingness to stop smoking after surgery
- Poor medical compliance, psychological disorders, substance abuse, or incomplete psychological clearance
- Unsuitable candidates based on multidisciplinary team evaluation and compliance concerns
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 2 weeks or until discharge
Participants undergo bladder transplantation or combined kidney and bladder transplantation. This includes surgical connections of donor organs to recipient vessels and urinary tract.
1 hospitalization period with daily assessments
Post-operative Follow-up
Duration - Up to 2 years
Participants are monitored for adverse events, immune rejection, and the functionality of the transplanted bladder.
Regular visits over 2 years for monitoring and assessments
Trial Site Locations
Total: 1 location
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
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Research Team
D
Dana Lopez, MPH
G
Gina Choi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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