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Bladder or Combined Kidney-Bladder Transplants for Bladder Disease

N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if bladder transplantation is safe and effective for patients with terminal bladder diseases who need a new bladder or a combined kidney and bladder transplant. Participants will undergo the transplant and be monitored for

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include complications related to surgery, rejection of the transplanted organ(s), infections, issues with urine storage and emptying, as well as side effects from immunosuppressive medications required after transplantation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Demonstrating the technical success of bladder or combined kidney-bladder transplantation
Secondary study objectives
Evaluate the functionality of the transplanted bladder
Incidence of adverse events after bladder or combined kidney-bladder transplantation
Incidence of immune rejection after bladder or combined kidney-bladder transplantation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,565 Previous Clinical Trials
10,263,184 Total Patients Enrolled
~2 spots leftby Apr 2025
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