Injections of muscle fiber fragments to treat fecal incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to regenerate functional anal sphincter muscle by injecting muscle fiber fragments that contain muscle precursor cells (MPCs). The hypothesis is that these fragments will effectively integrate into the host muscle tissue, aligning with the natural fiber direction, and will connect with the host's vascular and neural networks. Participants will be evaluated for their eligibility based on specific criteria related to fecal incontinence severity and anatomical defects. The intervention involves administering muscle fiber fragment injections to eligible participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Catherine Matthews, MD — Wake Forest University Health Sciences
• Study coordinator: Mary-Clare Day, RN, BSN
• Email: Maryclare.Day@advocatehealth.org
• Phone: 336.713.1343

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.