Phase III Trial of Autologous Skeletal Muscle Cell Injection to Treat Urge Fecal Incontinence from External Anal Sphincter Dysfunction

What this Trial Is About

Researchers are conducting a phase III trial to evaluate the safety and effectiveness of autologous skeletal muscle-derived cells for patients with urge fecal incontinence caused by dysfunction or damage to the external anal sphincter. This study aims to assess clinical outcomes in patients who have not sufficiently improved with conservative treatments. The condition involves uncontrolled leakage due to sphincter weakness or disruption. Participants receive either injections of their own skeletal muscle-derived cells into the external anal sphincter or a placebo solution. The study is randomized with two groups one receiving the investigational cell therapy and the other receiving the placebo vehicle. Both treatments are administered under medical supervision, and the study follows participants over a 12-month period to assess changes in incontinence episodes. During the trial, participants will be monitored for safety and efficacy through regular evaluations. The main outcome measured is the change in the frequency of incontinence episodes over 12 months. The study includes thorough assessments such as anal manometry and ultrasound imaging of the anal canal. Participants adherence, symptoms, and safety are carefully tracked through scheduled visits throughout the trial duration.

Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence