Bladder DiseaseNCT06337942
Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study
A study testing Bladder Transplantation and Combined Kidney and Bladder Transplantation in people with Bladder Disease and Bladder, Neurogenic, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bladder Disease, Bladder, Neurogenic, Bladder Cancer
- What is being tested?
- Bladder Transplantation and Combined Kidney and Bladder Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
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- Patient has been previously fully vaccinated and boosted against COVID-19, or is willing to undergo timely vaccination.
- 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 clean intermittent catheterization during pre-transplant workup.
- 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 must agree that said condition should not significantly enhance the surgical risks of genitourinary transplantation. Examples of such medical conditions would include burden of atherosclerotic disease that would preclude vascular anastomosis, and psychiatric disorders that would preclude reliable adherence to medications.
- No active co-existing psychosocial problems (i.e., alcoholism, drug abuse).
- Negative crossmatch with donor.
Who cannot join
- 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 deficiency, thrombocythemia, thalassemia, sickle cell disease.
- 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;
- 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 ratio, and partial thromboplastin time.
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- 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 can aid in the identification of patients who for example may not have the ability to comply with the medical directives necessary to care for a genitourinary transplant, or psychologically are not prepared for transplant, or who have unrealistic expectations about the transplant. The decision on eligibility is a team decision. All members of the team will discuss each candidate in a multidisciplinary meeting and reasons for concern over eligibility will be discussed at a Selection Committee Meeting. In circumstances where the candidate is considered to be less suitable, they could be given an opportunity to address these issues either through individual counseling or further education and then be reconsidered as a potential candidate. Every effort to prevent a request for allograft removal will be made.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA
Los Angeles, California, 90095
Magdalena Mendez-Smith, 310-267-7727, mmendezsmith@mednet.ucla.edu
Nima Nassiri, MD
About this study
Official title: Vascularized Composite Bladder Allograft Transplantation: a Phase 0 (First-in-human) Study for Deceased Donor Bladder or Combined Kidney-bladder Transplantation
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
- Bladder Disease, Bladder, Neurogenic, Bladder Cancer, Kidney Failure
- Being tested
- Bladder Transplantation, Combined Kidney and Bladder Transplantation
- Keywords
- terminal bladder, vascularized composite bladder allograft, bladder transplantation, combined kidney and bladder transplantation
- Medical subject headings
- Urinary Bladder Diseases, Urinary Bladder, Neurogenic, Urinary Bladder Neoplasms, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder TransplantationProcedure or surgery
A bladder transplantation will be performed. The bladder will be recovered from a brain-dead human donor. The connections that will be made will include connections between donor and recipient blood vessels, the bladder transplant and the recipient urethra, and the recipient's ureter(s) to the new bladder.
Combined Kidney and Bladder TransplantationProcedure or surgery
For patients who qualify for a combined kidney and bladder transplant, both a kidney and a bladder transplant will be performed. Both kidney and bladder allografts will be recovered from the same brain-dead human donor. The connections that will be made will include connections between donor and recipient blood vessels, the bladder transplant and the recipient urethra, and the kidney transplant ureter to the transplanted bladder. If the recipient has continued urine output, new connections between the native ureters and the transplanted bladder will also be made.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Transplantation | Experimental | Patients with terminal bladders who do not have kidney failure and who qualify for the study may undergo bladder transplantation. Receives: Procedure: Bladder Transplantation |
| Combined Kidney and Bladder Transplantation | Experimental | Patients with terminal bladders who also have kidney failure and who qualify for the study may undergo combined kidney and bladder transplantation. Receives: Procedure: Combined Kidney and Bladder Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrating the technical success of bladder or combined kidney-bladder transplantation
The technical success of bladder transplantation will be evaluated. Technical success is defined as sustained and adequate perfusion to the bladder to maintain viability, as assessed through cystoscopic visual inspection and imaging, including ultrasound and cross-sectional imaging.
Measured: 2 years
Secondary outcomes (3)
Incidence of adverse events after bladder or combined kidney-bladder transplantation
Adverse events will be evaluated. The endpoint for this outcome will be immediate peri-operative, 30, and 90-day adverse profiles. CTCAE v5 criteria will be used to describe adverse events. Of note a rejection episode managed medically will be defined as a grade 3 adverse event, while rejection requiring allograft explantation will be graded as a CTCAE grade 4 event.
Measured: 2 years
Incidence of immune rejection after bladder or combined kidney-bladder transplantation
Monitoring for immune or cell-mediated rejection will be monitored for the duration of the study. The endpoint for this outcome will be the incidence of acute (within 7 days) and delayed transplant rejection (up to 30 days) post-transplantation. Rejection will be graded using a modified histological grading system adapted from Banff criteria, similar to that adopted in uterine transplantation. This is adapted from pre-existing grading criteria for vascularized composite allograft rejection. Chronic rejection will be evaluated thereafter, up to 1 year at regular follow-up intervals.
Measured: 2 years
Evaluate the functionality of the transplanted bladder
The capacity of the bladder will be measured by ultrasound and cystoscopic visualization at 3 month intervals during the first year post-transplant, and as clinically indicated thereafter. The ability of the bladder to empty will be evaluated through using uroflowmetry studies at 3 month intervals and urodynamic evaluations. Successful bladder capacity is defined as a volume exceeding 300 cc, while successful bladder emptying will be defined by a post-void residual of less than 100 cc.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Feb 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bladder DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nima Nassiri, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337942
- Sponsor's protocol ID
- 23-001621
- Status last verified
- Feb 2025
- First submitted
- 15 Mar 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nassiri N, Gill IS. Combined bladder-kidney transplantation: first-in-human feasibility trial. Lancet. 2026 Jul 4;408(10549):31-37. doi: 10.1016/S0140-6736(26)00718-X. Epub 2026 Jun 23.
PubMed 42335920Shah AM. First Human Bladder Transplant. Artif Organs. 2025 Aug;49(8):1227-1228. doi: 10.1111/aor.15041. Epub 2025 Jun 12.
PubMed 40503649
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascularized Composite Bladder Allograft Transplantation: a Phase 0 (First-in-human) Study for Deceased Donor Bladder or Combined Kidney-bladder Transplantation
- ClinicalTrials.gov ID
- NCT06337942
- Acronym / sponsor ID
- 23-001621
- Conditions
- Bladder Disease, Bladder, Neurogenic, Bladder Cancer, Kidney Failure
- Keywords
- terminal bladder, vascularized composite bladder allograft, bladder transplantation, combined kidney and bladder transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder Transplantation | Experimental | Procedure: Bladder TransplantationPatients with terminal bladders who do not have kidney failure and who qualify for the study may undergo bladder transplantation. |
| Combined Kidney and Bladder Transplantation | Experimental | Procedure: Combined Kidney and Bladder TransplantationPatients with terminal bladders who also have kidney failure and who qualify for the study may undergo combined kidney and bladder transplantation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-70 years
- Positive history of one of the following:
- 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.
Key exclusion criteria (15 listed)
- Positive history of one of the following medical co-morbidities:
- Patient is either not vaccinated or is unwilling to undergo vaccination against COVID-19 prior to transplantation.
- Oncology patient specific:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder TransplantationA bladder transplantation will be performed. The bladder will be recovered from a brain-dead human donor. The connections that will be made will include connections between donor and recipient blood vessels, the bladder transplant and the recipient urethra, and the recipient's ureter(s) to the new bladder. | Procedure or surgery | Bladder Transplantation |
| Combined Kidney and Bladder TransplantationFor patients who qualify for a combined kidney and bladder transplant, both a kidney and a bladder transplant will be performed. Both kidney and bladder allografts will be recovered from the same brain-dead human donor. The connections that will be made will include connections between donor and recipient blood vessels, the bladder transplant and the recipient urethra, and the kidney transplant ureter to the transplanted bladder. If the recipient has continued urine output, new connections between the native ureters and the transplanted bladder will also be made. | Procedure or surgery | Combined Kidney and Bladder Transplantation |
Primary outcome
Demonstrating the technical success of bladder or combined kidney-bladder transplantation
Time frame: 2 years
The technical success of bladder transplantation will be evaluated. Technical success is defined as sustained and adequate perfusion to the bladder to maintain viability, as assessed through cystoscopic visual inspection and imaging, including ultrasound and cross-sectional imaging.
3 secondary outcomes
Incidence of adverse events after bladder or combined kidney-bladder transplantation
Time frame: 2 years
Incidence of immune rejection after bladder or combined kidney-bladder transplantation
Time frame: 2 years
Evaluate the functionality of the transplanted bladder
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 42335920Nassiri N, Gill IS. Combined bladder-kidney transplantation: first-in-human feasibility trial. Lancet. 2026 Jul 4;408(10549):31-37. doi: 10.1016/S0140-6736(26)00718-X. Epub 2026 Jun 23.
- Derived from this study: PubMed 40503649Shah AM. First Human Bladder Transplant. Artif Organs. 2025 Aug;49(8):1227-1228. doi: 10.1111/aor.15041. Epub 2025 Jun 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder Transplantation and Combined Kidney and Bladder Transplantation in people with Bladder Disease and Bladder, Neurogenic, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Lopez, MPH (310-794-8893, dlevinlopez@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrating the technical success of bladder or combined kidney-bladder transplantation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06337942, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.