Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
Trial Parameters
Brief Summary
The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction caused by its disruption and/or weakness.
Eligibility Criteria
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 externa