Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

Inclusion Criteria: * Patients must be at least 18 years old * Patients who are mentally competent and able to understand all study requirements * Female patients of childbearing potential willing to use appropriate methods of contraception * Patient has symptoms of urge fecal incontinence with a disease duration of at least 6 months and did not improve sufficiently by conservative treatment performed for at least 3 months * Urge fecal incontinence episodes that occur more than twice a week * Maximal incremental voluntary squeeze pressure (increase to resting pressure) on anal manometry is 100mmHg or less in women and 150mmHg or less in men * 9\. Ultrasound of the anal canal showing intact external anal sphincter or a maximal overall extent of external anal sphincter injury and tear of 180 degrees Exclusion Criteria: * Patients for whom the investigator determines that FI has a different cause than external anal sphincter dysfunction. * Patients with global fragmentation of the external anal sphincter as assessed by anal canal ultrasound * Patients who underwent any anorectal surgery within 6 months before screening visit * Patients who underwent a total of two or more external anal sphincter-related surgeries * Patients who currently have anal fistulas or fissures or have recurrent anal fistulas or fissures * Patients with poorly controlled chronic constipation including obstructed defecation syndrome * Patients with indications against a surgery under anesthesia * Patien…