Autologous Muscle Fiber Fragment Injections

NCT05396456 | Recruiting DMC

• 1 other identifier: IRB00085606
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fecal Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence

  Month 3

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

  fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence

  Month 6

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

  fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence

  Month 12

Secondary Outcomes (5)

• Change in Fecal Incontinence Quality of Life (FI-QOL) scores

  baseline, Months 3 and 12

• Anorectal Manometry (ARM) Pressure scores

  baseline, Months 3 and 12

• Internal Anal sphincter (IAS) Pressure scores

  baseline, Months 3 and 12

• Rectal Anal Inhibitory Reflex (RAIR) Pressure scores

  baseline, Months 3 and 12

• Fecal Incontinence Severity Index (FISI) scores

  baseline, Months 3 and 12

Other Outcomes (1)

• Anorectal endoscopic ultrasound (EUS)

  Months 3 and 12

Study Arms (1)

Muscle Fiber Fragment (MFF) injections

EXPERIMENTAL

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

Procedure: Muscle Fiber Fragment (MFF) Injections

Interventions

Muscle Fiber Fragment (MFF) Injections PROCEDURE

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.

Muscle Fiber Fragment (MFF) injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Injections

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Catherine Matthews, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary-Clare Day, RN, BSN

CONTACT

336.713.1343; Maryclare.Day@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with refractory Fecal Incontinence (FI) will be identified from the Atrium Wake Forest Baptist Health outpatient Gastroenterology, Urogynecology and Colorectal Surgery clinics.

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: January 12, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)