Bladder or Combined Kidney-Bladder Transplants for Bladder Disease

Overseen By Gina Choi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must be taking: Immunosuppressants

Disqualifiers: HIV, Hepatitis B/C, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the possibility of performing bladder transplants for individuals with severe bladder diseases. Depending on their condition, some participants will receive only a new bladder (Bladder Transplantation), while others will receive both a kidney and bladder transplant (Combined Kidney and Bladder Transplantation). The trial aims to determine if these transplants can function safely and effectively, particularly in storing and emptying urine. Ideal participants are those with serious bladder issues, possibly accompanied by kidney problems, who are already managing another organ transplant with medication. As an unphased trial, this study provides a unique opportunity for patients to contribute to groundbreaking research that could lead to new treatment options for severe bladder diseases.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on immunosuppression for a pre-existing organ transplant, you will continue with that treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bladder transplants have been promising in earlier tests. Initial results suggest they could be a safe and effective option for people with bladder issues. Some studies have found that using a donor bladder might be better accepted by the body than other methods, such as using a piece of the intestine to replace the bladder. This could lead to fewer problems after surgery.

For those needing both kidney and bladder transplants, there is also good news. In past cases, patients experienced quick improvements in kidney function after the transplant. This suggests that having both transplants at the same time might be well-tolerated.

It's important to remember that while these findings are encouraging, bladder transplants are still under study. Researchers continue to work hard to understand the long-term safety and effectiveness of these transplants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a groundbreaking approach for patients with severe bladder issues, especially those with kidney failure. Unlike traditional treatments, which might involve bladder augmentation or urinary diversion, bladder or combined kidney-bladder transplants aim to fully restore organ function by replacing the diseased bladder or both the bladder and kidney. This could mean a significant improvement in quality of life, as these transplants have the potential to provide a more permanent solution compared to existing surgical methods that often focus on managing symptoms rather than curing the underlying condition. Additionally, these transplants could reduce the long-term need for dialysis in patients with concurrent kidney failure, offering a more holistic treatment option.

What evidence suggests that this trial's treatments could be effective for bladder disease?

Research has shown that bladder transplantation, one of the treatments studied in this trial, is a groundbreaking procedure. Surgeons completed the first successful human bladder transplant at UCLA, marking a major achievement in surgery and offering hope for patients with serious bladder diseases. Early reports suggest that the new bladder functions well in storing and releasing urine.

For those needing both kidney and bladder transplants, the combined kidney and bladder transplantation, another treatment option in this trial, shows promising results. After the combined transplant, kidney function improved immediately, producing a large amount of urine right away. These findings suggest that combined kidney and bladder transplants could significantly advance the treatment of patients with severe organ failure. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with severe bladder conditions or kidney failure who might benefit from a new bladder or both a new bladder and kidney. Participants should be in need of these transplants due to terminal diseases affecting these organs.

Inclusion Criteria

My caretakers are strongly advised to get vaccinated.

Patient has been fully vaccinated and boosted against COVID-19 or is willing to undergo timely vaccination

Patients must demonstrate appropriate manual dexterity or sufficient assistance at home to perform clean intermittent catheterizations

Exclusion Criteria

I have a connective tissue or collagen disorder.

I do not have active HIV, hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, toxoplasmosis, or varicella zoster virus.

Severe anemia, leukopenia, or thrombocytopenia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants undergo bladder-only or combined kidney and bladder transplantation

Immediate

1 visit (in-person)

Initial Follow-up

Participants are monitored for immediate peri-operative, 30, and 90-day adverse profiles

3 months

Regular visits (in-person)

Long-term Follow-up

Participants are monitored for efficacy, safety, and functionality of the bladder transplant

2 years

Regular visits every 3 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bladder Transplantation
• Combined Kidney and Bladder Transplantation

Trial Overview The study is testing the feasibility and safety of transplanting a human bladder alone, or together with a kidney, into patients. It will assess how well the transplanted bladder can store urine and facilitate its release over two years.

How Is the Trial Designed?

Group I: Combined Kidney and Bladder Transplantation Experimental Treatment 1 Intervention

Patients with terminal bladders who also have kidney failure and who qualify for the study may undergo combined kidney and bladder transplantation.

Group II: Bladder Transplantation Experimental Treatment 1 Intervention

Patients with terminal bladders who do not have kidney failure and who qualify for the study may undergo bladder transplantation.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Renal transplantation in patients with reconstructed bladders has higher urologic complications, but overall graft and patient survival rates are similar to those with non-reconstructed bladders, based on a review of 25 articles.

It is recommended that bladder reconstruction be done prior to kidney transplantation when necessary, as this may help manage complications more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal transplantation in children with reconstructed bladders. Franc-Guimond, J., González, R.[2022]

In a study comparing 9 kidney transplant recipients who underwent simultaneous bladder augmentation (BA-KT) with 22 who had kidney transplants only, the BA-KT group showed better early graft function, with a higher estimated glomerular filtration rate (96.5 mL/min vs. 79.4 mL/min) within the first 6 months.

However, the BA-KT group experienced significantly higher rates of urinary tract infections (100% vs. 23% in the KT only group) and complications related to posttransplant care, leading to a notable decline in graft function by the fifth year, with only 66% of grafts functioning compared to 100% in the KT only group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Outcome of 1-step Kidney Transplantation and Bladder Augmentation Procedure in Pediatric Patients. Cleper, R., Ben Meir, D., Krause, I., et al.[2022]

This study successfully developed a technique for robotic retrieval and autotransplantation of vascularized bladder allografts in preclinical models, including living pigs and human cadavers, paving the way for future human trials.

The procedure demonstrated technical success with healthy revascularized autografts and maintained vascularity in heart-beating brain-dead donors, indicating the potential for safe and effective bladder transplantation in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Bladder Autotransplantation: Preclinical Studies in Preparation for First-in-human Bladder Transplant. Nassiri, N., Cacciamani, G., Gill, IS.[2023]

The study demonstrated that vascularized total bladder transplantation alongside kidney transplantation is feasible, as all grafts showed good blood supply and normal oxygen saturation during the observation period.

While one recipient experienced thrombosis leading to reduced urinary output, the other two recipients maintained normal bladder function, suggesting that with careful monitoring, this procedure could serve as a viable option for bladder augmentation or replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined kidney and vascularized total bladder transplantation: experience in an animal model. Torino, G., Capozza, N., Diomedi Camassei, F., et al.[2015]

The study demonstrated that urinary bladder vascularized composite allograft transplantation is technically feasible, as shown by successful mock transplants in two adult cadavers, indicating potential for future clinical applications.

This innovative approach could provide an alternative to using intestinal segments for bladder reconstruction, which may improve patient outcomes and reduce complications associated with intestinal grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility Study of Vascularized Composite Urinary Bladder Allograft Transplantation in a Cadaver Model. Gargollo, PC., Ahmed, ME., Prieto, M., et al.[2021]

In a study of 58 pediatric patients, three with severe bladder dysfunction who underwent augmentation cystoplasty prior to renal transplantation showed normal kidney function and no complications at follow-up periods of 13 to 49 months.

Augmentation cystoplasty appears to be a safe and effective treatment for these patients, with all subjects remaining continent and experiencing manageable urinary tract infections without affecting kidney graft function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal transplantation in children with augmentation enterocystoplasty. Aki, FT., Besbas, N., Ozcan, O., et al.[2006]

Kidney transplant recipients with prior bladder surgery face a significantly higher risk of graft failure and increased urinary complications, with a hazard ratio of 3.57 for graft survival, indicating a need for careful recipient selection.

Post-operative complications were notably higher in recipients with bladder dysfunction (35%) and those with bladder substitutes (52.3%), compared to only 12.8% in those with normal bladder function, highlighting the importance of monitoring these patients closely after transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Kidney Transplant Recipients with Bladder Dysfunction: A Single-Center Study. Srinivasan, D., Stoffel, JT., Mathur, AK., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05462561

Vascularized Composite Bladder Allograft Transplantation The objective of this study is to perform successful, safe robotic genitourinary bladder allotransplantation and define the optimal surgical techniques in up to ...

2. bcan.org bcan.org/clinicaltrials/deceased-donor-bladder-or-combined-kidney-bladder-transplantation-a-phase-0-first-in-human-study/

Deceased Donor Bladder or Combined Kidney ... 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 ...

3. uclahealth.org uclahealth.org/news/release/first-human-bladder-transplant-performed-ucla

First human bladder transplant performed at UCLA - Urology A UCLA surgical team has performed the first -in-human bladder transplant. The surgery was successfully completed at Ronald Reagan UCLA ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06337942

Study Details | NCT06337942 | Deceased Donor Bladder ... The goal of this clinical trial is to demonstrate the feasibility of bladder transplantation in patients with terminal bladder diseases who would benefit ...

5. renalandurologynews.com renalandurologynews.com/features/first-bladder-transplant/

First Bladder Transplant Offers New Hope for Patients ... The first bladder transplant in a living patient is the successful result of years of research and surgical innovation.

6. cancer.gov cancer.gov/clinicaltrials/NCI-2022-00076

Robotic Vascularized Composite Bladder Allograft ... A vascularized bladder allograft transplantation may provide a more durable and better tolerated alternative to urinary diversion using bowel in patients with ...