Autologous Muscle Fiber Fragment Injections

Exclusion Criteria

• •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