5 Participants Needed

Bladder or Combined Kidney-Bladder Transplants for Bladder Disease

DL
GC
Overseen ByGina Choi
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
Must be taking: Immunosuppressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What data supports the effectiveness of this treatment for bladder disease?

Research shows that kidney transplants into reconstructed bladders have similar survival rates to those into normal bladders, despite higher complications. This suggests that combining kidney and bladder transplants might be feasible, although more studies are needed to confirm effectiveness.12345

Is bladder or combined kidney-bladder transplantation safe in humans?

There is limited safety data specifically for bladder or combined kidney-bladder transplants in humans, but studies on kidney transplants in patients with bladder issues suggest that while there may be more complications, survival rates are similar to those without bladder issues.13456

How is the treatment of bladder or combined kidney-bladder transplants unique for bladder disease?

This treatment is unique because it involves transplanting a whole bladder or a combined kidney and bladder from a deceased donor, which has never been done in humans before. It aims to address complex bladder diseases by replacing the entire organ, unlike other treatments that may only reconstruct or augment the existing bladder.12567

What is the purpose of this trial?

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.

Eligibility Criteria

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
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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
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Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Combined Kidney and Bladder TransplantationExperimental Treatment1 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 TransplantationExperimental Treatment1 Intervention
Patients with terminal bladders who do not have kidney failure and who qualify for the study may undergo bladder transplantation.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Findings from Research

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.
Renal transplantation in children with reconstructed bladders.Franc-Guimond, J., González, R.[2022]
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.
Feasibility Study of Vascularized Composite Urinary Bladder Allograft Transplantation in a Cadaver Model.Gargollo, PC., Ahmed, ME., Prieto, M., et al.[2021]
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.
Long-Term Outcomes of Kidney Transplant Recipients with Bladder Dysfunction: A Single-Center Study.Srinivasan, D., Stoffel, JT., Mathur, AK., et al.[2019]

References

Renal transplantation in children with reconstructed bladders. [2022]
Feasibility Study of Vascularized Composite Urinary Bladder Allograft Transplantation in a Cadaver Model. [2021]
Long-Term Outcomes of Kidney Transplant Recipients with Bladder Dysfunction: A Single-Center Study. [2019]
Renal transplantation in children with augmentation enterocystoplasty. [2006]
Combined kidney and vascularized total bladder transplantation: experience in an animal model. [2015]
Long-term Outcome of 1-step Kidney Transplantation and Bladder Augmentation Procedure in Pediatric Patients. [2022]
Robotic Bladder Autotransplantation: Preclinical Studies in Preparation for First-in-human Bladder Transplant. [2023]
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