Phase I Study of Patients Own Engineered Urethral Tissue to Repair Urethral Strictures in Adult Men

What this Trial Is About

Researchers are evaluating the safety and effectiveness of using patients own engineered urethral tissue to treat urethral strictures in adult males. This Phase I study focuses on men aged 21 to 65 with recurrent urethral strictures who have previously undergone treatments like dilation or urethroplasty. The investigation is a single-center, prospective, non-randomized, and uncontrolled design aiming to develop personalized urethral constructs for repair. Participants will undergo a full-thickness bladder biopsy to collect their urothelial and smooth muscle cells. These cells will be grown in the lab and used to create a tubular scaffold called an autologous engineered urethral construct. About six weeks after the biopsy, participants will have surgery to remove the stricture and implant the engineered urethral tissue. The study involves follow-up monitoring for safety and efficacy over three years post-implant. Throughout the study, participants will have surgical procedures, laboratory cell culture, and long-term follow-up visits. Researchers will monitor adverse events related to the biopsy, the implant procedure, and the urethral construct itself for up to 36 months. The main outcome measured is the incidence of product- and procedure-related side effects, while effectiveness of the repair will also be assessed during the follow-up period.

Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures