Injections of a person's own muscle fiber fragments for fecal incontinence

You may qualify if

• 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

You can't join if

• 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