An interventional study of Bladder Transplantation and Combined Kidney and Bladder Transplantation in Bladder Disease, Bladder, Neurogenic and Bladder Cancer, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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:
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.
62 studies on the registry are indexed under Urinary Bladder Diseases; 9 are open to participants now.
This study's planned enrollment of 5 is below the median of 79 across 42 interventional studies indexed under Urinary Bladder Diseases.
Browse Urinary Bladder Diseases studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Positive history of one of the following:
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.
Exclusion Criteria:
Positive history of one of the following medical co-morbidities:
Oncology patient specific:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with terminal bladders who do not have kidney failure and who qualify for the study may undergo bladder transplantation.
Procedure: Bladder Transplantation
Patients with terminal bladders who also have kidney failure and who qualify for the study may undergo combined kidney and bladder transplantation.
Procedure: Combined Kidney and Bladder Transplantation
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.
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.
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.
Time frame: 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Jan 2027, 23 months after the start.
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