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 ofcontraception

• 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 atleast 3 months

• Urge fecal incontinence episodes that occur more than twice a week

• Maximal incremental voluntary squeeze pressure (increase to resting pressure) onanal 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 amaximal overall extent of external anal sphincter injury and tear of 180degrees

Exclusion Criteria:

• Patients for whom the investigator determines that FI has a different cause thanexternal anal sphincter dysfunction.

• Patients with global fragmentation of the external anal sphincter as assessed byanal 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-relatedsurgeries

• Patients who currently have anal fistulas or fissures or have recurrent analfistulas or fissures

• Patients with poorly controlled chronic constipation including obstructed defecationsyndrome

• 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 studyenrolment and/or chemotherapy related neuropathy of the bowel and pelvis

• Patients with compromised immune system and/or rheumatic disease, and patients underimmunosuppressive therapy

• Patients with a diagnosis of chronic inflammatory bowel disease (e.g Crohn'sdisease, Colitis Ulcerosa)

• Patients suffering from a disease which has not been resolved within 4 weeks priorto screening including fever and/or diarrhea of unknown reasons (4 weeks)

• Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viralhepatitis HCV, acute or chronic viral hepatitis HBV, active Syphilis or HTLV (testedupon risk assessment by investigator)

• Patients diagnosed with any kind of skeletal muscle disease and/or neuronaldisorders

• Patients with severe myocardial disorders, irregular pulse or a pacemaker

• Patients with implantations of metal components in the electrical stimulationtreatment area

• Patients with uncontrolled diabetes mellitus type I or II, or suffering fromdiabetic peripheral neuropathic pain

• Patients with clinically relevant abnormal laboratory values judged by theresponsible investigator as relevant for the study treatment