Bladder or Combined Kidney-Bladder Transplants for Bladder Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Must be taking: Immunosuppressants
Disqualifiers: HIV, Hepatitis B/C, Tuberculosis, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
13456How 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.
12567Eligibility 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
+10 more
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
+8 more
Trial 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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
UCLALos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
References
Renal transplantation in children with reconstructed bladders. [2022]In this article, we review the outcome and complications of renal transplantation in patients with reconstructed bladders and address specific issues and controversies regarding the management of such cases. Twenty-five articles covering the subjects of renal transplantation, lower urinary tract anomalies, and bladder reconstruction have been selected. Although urologic complications are higher when kidneys are transplanted into reconstructed bladders or urinary diversions, the graft and patient survival rates in most series are comparable with those transplanted into nonreconstructed bladders. The reported series of renal transplantation into abnormal bladders are small, and controlled studies are lacking. Bladder reconstruction should be performed before transplantation when clinically indicated.
Feasibility Study of Vascularized Composite Urinary Bladder Allograft Transplantation in a Cadaver Model. [2021]The purpose of this study was to establish the feasibility of performing a urinary bladder vascularized composite allograft transplantation for either bladder augmentation or neobladder creation.
Long-Term Outcomes of Kidney Transplant Recipients with Bladder Dysfunction: A Single-Center Study. [2019]Long-term outcomes of kidney transplantation recipients with bladder dysfunction or prior bladder surgery are not well characterized.
Renal transplantation in children with augmentation enterocystoplasty. [2006]We report our experience with renal transplantation in patients with severe bladder dysfunction who underwent prior augmentation cystoplasty.
Combined kidney and vascularized total bladder transplantation: experience in an animal model. [2015]Few reports have described a partial bladder graft with an en bloc kidney transplantation, mainly to facilitate reconstruction of the urinary tract, but also to augment the native bladder. The present study assessed the feasibility to graft vascularized total bladder in association with a renal transplantation.
Long-term Outcome of 1-step Kidney Transplantation and Bladder Augmentation Procedure in Pediatric Patients. [2022]Guidelines for bladder augmentation (BA) in kidney transplantation (KT) recipients are not well-defined. In our center, simultaneous BA with KT (BA-KT) is performed. We assessed transplantation outcomes of this unique extensive procedure.
Robotic Bladder Autotransplantation: Preclinical Studies in Preparation for First-in-human Bladder Transplant. [2023]Human urinary bladder transplantation has never been performed. From a technical standpoint, challenges include the complex deep pelvic vascular anatomy, limited intraoperative visualization, and high procedural complexity. In preparation for a first-in-human clinical trial, we report preclinical studies to develop the technique of robotic retrieval and autotransplantation of vascularized composite bladder allograft.