Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study
Eligible age
18–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of California, Los Angeles
You may qualify if…
- ✓ Age 18-70 years
- ✓ Positive history of one of the following:
- ✓ 1. Terminal bladder pathology resulting in poor compliance, recurrent refractory infections, and/or and resultant upper tract (kidney and ureteral) pathology, with possible resultant kidney disease.
- ✓ 2. Localized, non-metastatic, bladder cancer requiring radical cystectomy. In this protocol, the only patients with a history of urothelial cell carcinoma that has already been treated, with an appropriate disease-free interval would be considered. Moreover, only candidates requiring a joint kidney and bladder transplantation or patients with a pre-existing transplant, on standard immunosuppression, will be considered.
- ✓ 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.
- ✓ (a) Caretakers of the recipient will be strongly encouraged to be vaccinated.
You may not qualify if…
- ✕ Positive history of one of the following medical co-morbidities:
- ✕ 1. HIV (active or seropositive), active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, viral encephalitis, toxoplasmosis, varicella zoster virus
- ✕ 2. Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like hemophilia, Von-Willebrand's disease, protein C and S deficiency, thrombocythemia, thalassemia, sickle cell disease.
- ✕ 3. Mixed connective tissue diseases and collagen disorders (can result in poor wound healing after surgery), including: mixed connective tissue disorder; severe deforming rheumatoid arthritis; infectious, post-infectious, or inflammatory (axonal or demyelinating) neuropathy; Ehlers-Danlos syndrome;
- ✕ 4. lipopolysaccharidosis or amyloidosis (effects nerve regeneration)
- ✕ 5. Impaired liver function as evaluated by liver function panel, including the presence of hyperbilirubinemia, elevated AST/ALT, and the presence of secondary coagulopathy, measured by prothrombin, international normalized ratio, and partial thromboplastin time.
- ✕ 6. Severe anemia (hemoglobin \< 7 g/dL), leukopenia (WBC \< 3 x 109 cell/L), or thrombocytopenia (platelets \< 20 x109 cells/L).
- ✕ Patient is either not vaccinated or is unwilling to undergo vaccination against COVID-19 prior to transplantation.
Where it's recruiting
Los Angeles
Source: ClinicalTrials.gov · NCT06337942 · last updated 2025-02-12