University of Southern California
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.
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 t…
Inclusion Criteria: * Age 18-80 years. * Positive history of one of the following: * Bladder pathology resulting in poor compliance, recurrent infections, and/or resultant upper tract (kidney and ureteral) pathology, demonstrated by hydronephrosis with resultant kidney disease. * Localized, non-metastatic, muscle-invasive or lesser urothelial cell carcinoma of the bladder that requires therapeutic radical cystectomy will be considered only if the patient is already on pre-existing immunosuppression or who are expected candidates for immunosuppression in the near future, and then on a cas…
Ancillary studies
Undergo robotic VCBA transplantation.
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