Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
• 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