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New treatment option for Bladder Disease
Official title Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study
ClinicalTrials.gov ID: NCT06337942
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18-70 years
- Positive history of one of the following:
- Terminal bladder pathology resulting in poor compliance, recurrent refractory infections, and/or and resultant upper tract (kidney and ureteral)...
- Localized, non-metastatic, bladder cancer requiring radical cystectomy. In this protocol, the only patients with a history of urothelial cell...
- Patients that are on immunosuppression for pre-existing solid organ transplantation will be included in this study.
You likely can't join if
- Positive history of one of the following medical co-morbidities:
- HIV (active or seropositive), active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, viral encephalitis, toxoplasmosis...
- Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited...
- Mixed connective tissue diseases and collagen disorders (can result in poor wound healing after surgery), including: mixed connective tissue...
- lipopolysaccharidosis or amyloidosis (effects nerve regeneration)
- Impaired liver function as evaluated by liver function panel, including the presence of hyperbilirubinemia, elevated AST/ALT, and the presence of...
See the full eligibility criteria
- Age 18-70 years
- Positive history of one of the following:
- 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.
- 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...
- 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.
- Patients must demonstrate appropriate manual dexterity or sufficient assistance at home to perform clean intermittent catheterizations as needed. The patient (or assistant) must demonstrate proficiency in performing...
- No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results. If the condition is amenable to treatment, the study team...
- No active co-existing psychosocial problems (i.e., alcoholism, drug abuse).
- Negative crossmatch with donor.
- Positive history of one of the following medical co-morbidities:
- HIV (active or seropositive), active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, viral encephalitis, toxoplasmosis, varicella zoster virus
- 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...
- 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...
- lipopolysaccharidosis or amyloidosis (effects nerve regeneration)
- 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...
- 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.
- Oncology patient specific:
- History of non-urothelial malignancy in past 5 years, with the exception of non-melanomatous skin cancer
- History of malignancy involving metastases
- Patients unable to receive adequate follow-up care and/or unable to receive immunosuppression due to geographic, financial or other reasons.
- Patients with a smoking history who cannot demonstrate smoking cessation for a period of 6 months prior to listing and a desire to abstain from post-operative smoking will be excluded.
- Records of poor medical compliance, documented psychological disorder(s), substance abuse or incomplete psychological clearance.
- Particular attention will be paid to the candidate's compliance and their desire to undergo the offered procedure. While there is no "score" on any particular evaluation that would rule out a patient, certain factors...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.