Autologous Muscle Fiber Fragment Injections for Fecal Incontinence

This study is testing a new treatment for fecal incontinence (FI), a condition where you have trouble controlling your bowel movements. The treatment involves injecting your own muscle fiber fragments (MFF) into the external anal sphincter (the muscle that helps control bowel movements). Researchers believe these fragments, which contain muscle precursor cells, could help regenerate functional muscle. To join, you must be at least 18 years old, experience at least 4 FI episodes every two weeks, score over 10 on the Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS), and have had symptoms for at least 12 months, with previous treatments not working. The study will measure success by looking at changes in your CCIS scores at 3, 6, and 12 months after the injection. The current status of this study is unclear, and it plans to enroll 10 participants.

Study design: This is an interventional study with no specified phase, planning to enroll 10 participants.
What's involved: You would receive injections of muscle fiber fragments into your external anal sphincter. The trial record does not specify the number of visits or other procedures.
Compensation: Not stated in the trial record.
Follow-up: Your fecal incontinence severity will be measured at 3, 6, and 12 months after the injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Autologous Muscle Fiber Fragment Injections

Recruiting

NAAges 18+InterventionalTreatment

Wake Forest University Health Sciences

~10 participants

Updated 2026-02-27 on ClinicalTrials.gov

What's tested:Muscle Fiber Fragment (MFF) Injections

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)

Measured over Month 3

+2 more outcomes measured

Conditions

Fecal Incontinence

Where it's being run

1 sites across 1 states

North Carolina1

Study leadership

Catherine Matthews, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Mary-Clare Day, RN, BSN

[email protected]

336.713.1343

Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)Month 3
fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence
Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)Month 6
fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence
Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)Month 12
fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence

Trialytics