Autologous Muscle Fiber Fragment Injections

Inclusion Criteria: * 18 years of age * participants must experience 4 or more Fecal Incontinence (FI) episodes per 2 week period * participants must score \>10 on Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) * participants must have had symptoms for at least 12 months * participants who have failed standard medical and surgical treatments for FI * participant will undergo anorectal manometry (ARM) testing * participants will undergo endoscopic anal ultrasound and demonstrate an anatomic defect of the anal sphincter complex of at least 30 degrees * women of childbearing potential must use acceptable contraceptives during this study Exclusion Criteria: * participants with symptomatic anorectal disease including symptomatic hemorrhoid disease, anal fissure or fistula causing symptoms such as bleeding, swelling, pain, or drainage * participants with pre-existing ano-rectal pain of any cause * participants with incontinence of flatus only * chronic watery diarrhea which is the primary cause for fecal incontinence * acute or chronic anorectal infections (including proctitis, recurrent abscesses, fistulae) * presence of anorectal tumors * active proctitis or inflammatory bowel disease * previous injection of internal anal sphincter (IAS) with bulking agents * participants requiring immunosuppression or who have any malignant disease within 3 years of enrollment * participants with a defined bleeding disorder diagnosed and treated by a hematologist * other e…