Actively Recruiting
Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study
Led by University of California, Los Angeles · Updated on 2025-02-12
5
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- History of terminal bladder disease causing poor bladder compliance, recurrent infections, or kidney/ureter damage
- Localized, non-metastatic bladder cancer needing radical cystectomy, with specific criteria for urothelial carcinoma patients
- Currently on immunosuppression for prior organ transplant
- Agreement to follow the study protocol and immunomodulatory treatment
- Fully vaccinated and boosted against COVID-19, or willing to get vaccinated
- Ability or assistance to perform clean intermittent catheterization, demonstrated during pre-transplant evaluation
- No medical conditions that would increase surgical risk or affect treatment, as determined by the study team
- No active psychosocial problems like alcoholism or drug abuse
- Negative crossmatch test with donor
You will not qualify if you...
- Active or positive history of HIV, active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, toxoplasmosis, or varicella zoster virus
- Medical conditions increasing surgical risk, such as inherited bleeding disorders (hemophilia, Von-Willebrand's, protein C/S deficiency, thrombocythemia, thalassemia, sickle cell disease)
- Mixed connective tissue diseases or collagen disorders affecting healing, including severe rheumatoid arthritis, neuropathies, Ehlers-Danlos syndrome
- Lipopolysaccharidosis or amyloidosis
- Impaired liver function with abnormal liver tests or coagulopathy
- Severe anemia (Hb <7 g/dL), leukopenia (WBC <3 x 10^9/L), or thrombocytopenia (platelets <20 x 10^9/L)
- Not vaccinated or unwilling to vaccinate against COVID-19 prior to transplant
- History of non-urothelial cancer within 5 years except non-melanoma skin cancer
- History of metastatic cancer
- Inability to receive proper follow-up or immunosuppression due to location, finances, or other reasons
- Smoking history without at least 6 months cessation and willingness to abstain post-op
- Poor medical compliance, psychological disorders, substance abuse, or incomplete psychological clearance
- Lack of ability or motivation to comply with transplant care and treatment as determined by the study team
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
D
Dana Lopez, MPH
CONTACT
G
Gina Choi
CONTACT
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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