Actively Recruiting
Robotic Vascularized Composite Bladder Allograft Transplantation: A Phase 0 First-in-Human Study for Deceased-Donor Bladder Transplantation
Led by University of Southern California · Updated on 2026-01-20
5
Participants Needed
1
Research Sites
52 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 research aims to assess the feasibility, function, and sustainability of vascularized composite bladder allograft transplantation in patients with severe bladder conditions. This approach may offer a more lasting and better-tolerated alternative to the standard urinary diversion method that uses bowel tissue. The study focuses on performing successful human bladder transplants using robotic surgical methods. Participants will undergo a robotic vascularized composite bladder allograft transplantation, receiving a bladder from a deceased donor. The study will use standard triple-therapy immunosuppression to support the transplant. After surgery, patients will stay in a specialized urology care unit for close monitoring and then move to a regular hospital floor before discharge. Routine bladder biopsies and urine output evaluations will be performed at scheduled intervals to check graft health and function over the first year. During the study, participants will be closely monitored both in the hospital and outpatient settings, with frequent visits for lab tests, medication management, and bladder function assessments. Researchers will track surgical success, transplant rejection episodes, adverse events, and bladder functionality at several time points up to one year. The total duration of monitoring includes inpatient care for about one to three weeks post-surgery, followed by regular follow-up visits for ongoing evaluation and management.
CONDITIONS
Brief 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 needing cystectomy only if on or expected to need immunosuppression
- Patients on pre-existing immunosuppression
- Willingness to follow the immunomodulatory treatment plan
- Ability or assistance to perform clean intermittent catheterization
- No medical condition affecting surgery or immunomodulatory treatment
- No active psychosocial problems like alcoholism or drug abuse
- Negative crossmatch with donor
- Donor must be brain dead, age 18-65, ABO compatible, and stable without excessive vasopressors
You will not qualify if you...
- Active or seropositive HIV, 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/S deficiency, thrombocythemia, thalassemia, or sickle cell disease
- Connective tissue or collagen disorders including severe rheumatoid arthritis, mixed connective tissue disorder, inflammatory neuropathies, or Ehler-Danlos syndrome
- Lipopolysaccharidosis or amyloidosis
- Impaired liver function or secondary coagulopathy
- Severe anemia, leukopenia, or thrombocytopenia
- History of non-urothelial cancer in past 5 years except low-risk skin or prostate cancer
- History of metastatic cancer in past 5 years
- Urothelial carcinoma without pre-existing immunosuppression
- Sensitized recipients with PRA ≥80% or donor-specific antibodies
- Inability to receive follow-up or immunosuppression due to financial, geographic, or other reasons
- Smoking history without 6 months cessation
- Poor medical compliance, psychological disorders, substance abuse, or incomplete psychological clearance
- Donor with unresolved sepsis, cancer, bladder/prostate surgery, abnormal bladder capacity, active sexually transmitted disease, active CMV, EBV or TB infection, or positive hepatitis B/C or HIV status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 3 weeks
Participants undergo robotic vascularized composite bladder allograft transplantation followed by close inpatient monitoring including daily examinations and ultrasound evaluations to detect signs of rejection and manage complications.
Daily inpatient monitoring for 7 days post-surgery, then transition to regular floor until discharge
Duration - Up to 1 year
Participants attend outpatient visits for transplant rejection monitoring, immunosuppression management, and bladder function assessment with protocol biopsies at 1 month and every 3 months through cystoscopy during the first year.
Weekly visits for 1 month, then biweekly visits for 1 month, then monthly visits for 6 months, then visits every 3 months
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
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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