Vascularized Composite Bladder Allograft Transplantation

Immunosuppression Clinical Trial

Official title: Robotic Vascularized Composite Bladder Allograft Transplantation: A Phase 0 (First-in-Human), Single Institutional Study for Deceased-Donor Bladder Transplantation

Status Recruiting

Clinical Trial Summary

This phase 0 trial tests the feasibility, functionality, and sustainability of vascularized composite bladder allograft transplantation in treating patients with terminal bladder pathology. A vascularized bladder allograft transplantation may provide a more durable and better-tolerated alternative to standard urinary diversion, which employs bowel. A robotic surgical approach will be employed.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To perform a feasibility study of vascularized composite bladder allograft (VCBA) transplantation and demonstrate successful transplantation of a vascularized composite deceased-donor bladder allograft.

SECONDARY OBJECTIVES:

I. To describe the adverse events associated with VCBA transplantation.

II. To describe the immunosuppression regimen for patients undergoing VCBA transplantation.

III. To evaluate allografted bladder functionality (storage and emptying) after transplantation.

OUTLINE:

This study will be the first to report on the feasibility of human bladder transplantation. In the appropriately selected candidate, a vascularized bladder allograft transplantation may provide a more durable and better-tolerated alternative to urinary diversion using the bowel. The objective of this study is to perform successful, safe robotic genitourinary bladder allotransplantation and define the optimal surgical techniques in up to 5 genitourinary patients using standard triple-therapy immunosuppression. A multi-institutional, multidisciplinary Genitourinary Vascularized Composite Bladder Allograft Transplantation Team has been established to address this aim.

Brain dead donors who have met the criteria for Determination of Death will be selected by the Genitourinary transplant team in conjunction with the organ procurement organization (OPO) for the University of Southern California, OneLegacy. The mandatory requirements are family consent for donation. These criteria are standard and are not part of the research question at hand.

A robotic vascularized composite bladder allograft transplantation will be performed, after which patients will be monitored closely as both an inpatient and at serial timepoints after surgery in the outpatient setting.

This is the critical period when most of the surgical complications leading to allografts loss can take place. During this period, VCBA recipients will remain at the Keck USC Urology Step-down Unit for 7 days following the surgery, from where they will be moved to the regular floor. Daily examinations and post-operative ultrasound evaluation will be performed by the urology service to monitor for signs of rejection. The patient will have protocol biopsies as detailed below and during any rejection episodes. Once drug levels are stable and therapeutic and the patient is without complications, the process of discharge with close follow-up will be initiated.

Immediately after surgery, discharge will typically occur 1-3 weeks following transplantation. A detailed explanation of postoperative discharge instructions will be provided by the discharge nurse, social worker, and transplant coordinator and will include: medication dosages and associated adverse effect profiles (the patient will be instructed to record the time of all medications taken); schedule of required laboratory draws; timing of physician follow-up visits; wound care; assessment of urine output; diet; monitoring of blood pressure and temperature; hygiene; dental care; opportunistic infection prevention; use of gloves and masks; activity and exercise; maintaining a nonsmoking environment; driving; child immunization; caring for house pets; and other special instructions. The endpoint is the success of the transplant, measured by adequate blood flow and no signs of complications.

Evaluation of bladder integrity, including urine output, will be an essential component of transplant surveillance. In addition, graft biopsies will be routinely performed at one month after surgery and every 3 months through cystoscopy during the first year, plus whenever clinically indicated. Biopsies are taken from the bladder dome during in-office cystoscopy. Hemostasis is achieved through Bugby electrocautery. This is a common urologic procedure performed in outpatient surgery centers and urology clinics nationwide. The clinical care needs of each patient will likely be individually different after genitourinary transplantation and will thus be adjusted specifically per patient. Daily monitoring of the quality and quantity of urine output is considered clinically particularly relevant for monitoring graft rejection. Briefly, allograft recipients need to visit the transplant clinic staff once a week for the 1st post-operative month, then once every other week for 1 month, then once monthly for 6 months, and thereafter once every 3 months for the management of immunosuppression and assessment of rejection. ;

Related Conditions & MeSH terms

• Bladder Dysfunction
• Immunosuppression
• Neurogenic Bladder
• Urinary Bladder, Neurogenic

• NCT number: NCT05462561
• Study type: Interventional
• Source: University of Southern California
• Contact: Ileana Aldana
• Phone: 323-865-0702
• Email: Ileana.aldana@med.usc.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Completion date: May 1, 2026