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
• Patients with a malignant disease not in remission for 5 years or more
• Patients who have undergone radiation therapy of the bowel and pelvis
• Patients who have undergone chemotherapy within last 5 years prior to study enrolment and/or chemotherapy related neuropathy of the bowel and pelvis
• Patients with compromised immune system and/or rheumatic disease, and patients under immunosuppressive therapy
• Patients with a diagnosis of chronic inflammatory bowel disease (e.g Crohn's disease, Colitis Ulcerosa)
• Patients suffering from a disease which has not been resolved within 4 weeks prior to screening including fever and/or diarrhea of unknown reasons (4 weeks)
• Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepatitis HCV, acute or chronic viral hepatitis HBV, active Syphilis or HTLV (tested upon risk assessment by investigator)
• Patients diagnosed with any kind of skeletal muscle disease and/or neuronal disorders
• Patients with severe myocardial disorders, irregular pulse or a pacemaker
• Patients with implantations of metal components in the electrical stimulation treatment area
• Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain
• Patients with clinically relevant abnormal laboratory values judged by the responsible investigator as relevant for the study treatment