Autologous Muscle Fiber Fragment Injections

This study is testing whether injecting a person's own muscle fiber fragments — which contain muscle repair cells — directly into the damaged anal sphincter muscle can improve fecal incontinence, a condition where a person cannot control bowel movements. Fecal incontinence significantly affects quality of life, and this approach aims to regenerate functional muscle tissue using the patient's own cells. Adults aged 18 and older who experience at least 4 episodes of fecal incontinence per two-week period, have had symptoms for at least 12 months, have failed standard treatments, and have a confirmed sphincter defect on ultrasound are eligible, while those with active rectal infections, inflammatory bowel disease, recent anorectal surgery, or pregnancy are excluded. Participation involves a small muscle biopsy to collect the fiber fragments, an injection procedure, and follow-up visits to assess improvement in continence. This summary was prepared to help patients understand the study in plain language.