Treatment of Fecal Incontinence with Autologous Muscle Fiber Fragment Injections Using Muscle Precursor Cells from Quadriceps Muscle

What this Trial Is About

This clinical trial focuses on treating fecal incontinence by regenerating functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells. Researchers are exploring whether these fragments can successfully integrate into the host muscle tissue, vascular, and neural networks to improve symptoms in men and women who have anal sphincter defects and have not responded to standard treatments. Participants will receive injections of muscle fiber fragments obtained from their own quadriceps muscle. These injections are administered into the external anal sphincter at four locations 3, 6, 9, and 12 oclock using a fine needle. The treatment schedule and procedure details are designed to encourage integration of the fragments with the participants native muscle fibers. During the study, participants will be monitored through various assessments including scoring their fecal incontinence severity using the Cleveland Clinic Fecal Incontinence Severity Scoring System at 3, 6, and 12 months. Additional evaluations include quality of life questionnaires, anorectal manometry pressure tests, and anal ultrasound imaging. Safety and treatment effects will be followed over time, with the total participation duration extending up to one year after treatment.

Autologous Muscle Fiber Fragment Injections