Actively Recruiting
Vascularized Composite Bladder Allograft Transplantation
Led by University of Southern California · Updated on 2026-01-20
5
Participants Needed
1
Research Sites
283 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase 0 trial tests the feasibility, functionality, and sustainability of vascularized composite bladder allograft transplantation in treating patients with terminal bladder pathology. A vascularized bladder allograft transplantation may provide a more durable and better-tolerated alternative to standard urinary diversion, which employs bowel. A robotic surgical approach will be employed.
CONDITIONS
Official Title
Vascularized Composite Bladder Allograft Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- History of bladder pathology causing poor compliance, recurrent infections, or kidney/ureter problems
- Patients with localized, non-metastatic bladder cancer requiring cystectomy only if already on or expected to need immunosuppression
- Patients on pre-existing immunosuppression
- Agreement to follow the immunomodulatory treatment plan
- Ability or assistance to perform clean intermittent catheterization, demonstrated proficiency before transplant
- No medical conditions that increase surgical risk or affect treatment outcomes
- No active psychosocial problems such as alcoholism or drug abuse
- Negative crossmatch with donor
- Donor must be brain dead, age 18 to 65, stable, ABO compatible, and negative crossmatch with recipient
You will not qualify if you...
- Active or seropositive HIV, active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, toxoplasmosis, varicella zoster virus
- Conditions affecting surgery success or healing, including inherited coagulopathies and connective tissue diseases like Ehler-Danlos syndrome
- Lipopolysaccharidosis or amyloidosis
- Impaired liver function or secondary coagulopathy
- Severe anemia, leukopenia, or thrombocytopenia
- History of non-urothelial cancer within past 5 years except low-risk skin or prostate cancer
- History of metastatic cancer within past 5 years
- History of urothelial carcinoma without need or expectation for immunosuppression
- Sensitized recipients with PRA ≥ 80%, donor-specific antibodies, or positive crossmatch
- Inability to receive follow-up or immunosuppression due to geographic, financial, or other issues
- Smoking history without 6 months cessation and plan to abstain post-op
- Poor medical compliance, psychological disorders, substance abuse, or incomplete psychological clearance
- Donor with unresolved sepsis, bladder or prostate cancer history, bladder surgery, abnormal bladder capacity, active sexually transmitted diseases, active CMV, EBV, TB infections, or positive for HBV, HCV, or HIV/AIDS
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
Research Team
I
Ileana Aldana
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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