Autologous Muscle Fiber Fragment Injections

Eligibility Criteria

• * 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
• * participants with symptomatic anorectal disease including symptomatic hemorrhoid disease, anal fissure or fistula causing symptoms such as bleeding, swelling, pain, or drainage
• * participants with pre-existing ano-rectal pain of any cause
• * participants with incontinence of flatus only
• * chronic watery diarrhea which is the primary cause for fecal incontinence
• * acute or chronic anorectal infections (including proctitis, recurrent abscesses, fistulae)
• * presence of anorectal tumors
• * active proctitis or inflammatory bowel disease
• * previous injection of internal anal sphincter (IAS) with bulking agents
• * participants requiring immunosuppression or who have any malignant disease within 3 years of enrollment
• * participants with a defined bleeding disorder diagnosed and treated by a hematologist
• * other exclusions include history of pelvic radiation, rectal prolapse, anorectal malformations, anorectal surgery within the previous 12 months, or treatments using injection or infrared coagulation for treatment of hemorrhoids
• * participants with neurologic disease characterized by significant peripheral neuropathy or spinal cord dysfunction
• * women who are pregnant, breastfeeding, or have had a child within the last year
• * participants with a history of unstable cardiac function (New York Heart Association Functional Classification III or IV) or unstable pulmonary function requiring home oxygen, or abnormal kidney function (Cr \>1.5 mg/dl or on dialysis) or uncontrolled diabetes (Hemoglobin A1C \> 8 mg/dl)
• * participants with anemia (hemoglobin \<10g, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2 times normal) or increased bilirubin \>1.5mg/dl
• * participants with Hepatitis B or C, or human immunodeficiency virus (HIV)-1 or 2
• * rectal prolapse
• * vaginal prolapse beyond the hymen
• * unable to understand informed consent information even with provision of a medical translator