Recruiting

Muscle Fiber Fragments

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05396456

Conditions

Fecal Incontinence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Muscle Fiber Fragment (MFF) Injections

Study Details

Brief summary:

To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)

Conditions

Fecal Incontinence

Study ID

NCT05396456

Start date

Jan 12, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Muscle Fiber Fragment (MFF) injections

autologous muscle fiber fragment injections, harvested in an autologous fashion from the quadriceps muscle, for the treatment of Fecal Incontinence (FI) symptoms in men and women with a demonstrated anal sphincter defect and who have failed conservative treatments

Interventions

Muscle Fiber Fragment (MFF) Injections

The participant will be treated with an injection of muscle fiber fragments into the external anal sphincter at 3, 6, 9 and 12 o'clock using a 21-gauge needle to a depth of 1-2 cm from the external skin using equal amounts in each quadrant.

Primary outcome measure

  • Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score) [ Time Frame: Month 3 ]
  • Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score) [ Time Frame: Month 6 ]
  • Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score) [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Mary-Clare Day, RN, BSN

336.713.1343Maryclare.Day@advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Mary-Clare Day, RN, BSN

336-713-1343Maryclare.Day@advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • low anal pressures
  • passive incontinence
  • bowel movements
  • sphincter muscle

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-02-27.