Autologous Muscle Fiber Fragment Injections

Inclusion 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

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