Autologous Muscle Fiber Fragment Injections

Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence

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

Study Overview

• Status: Recruiting
• Conditions: Fecal Incontinence
• Intervention / Treatment: Procedure: Muscle Fiber Fragment (MFF) Injections

Detailed Description

The Study hypothesizes that efficient re-assembly of injected fragments within host muscle tissue along the fiber direction of native muscle will be induced. It is anticipated that these fiber fragments would integrate into the host vascular and neural network.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary-Clare Day, RN, BSN; Phone Number: 336.713.1343; Email: Maryclare.Day@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Mary-Clare Day, RN, BSN; Phone Number: 336-713-1343; Email: Maryclare.Day@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fecal Incontinence Quality of Life (FI-QOL) scores	The Fecal Incontinence Quality of Life Scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items), Coping/Behavior (9 items), Depression/Self-Perception (7 items), and Embarrassment (3 items).	baseline, Months 3 and 12
Anorectal Manometry (ARM) Pressure scores	Low resting pressure is defined as <50 mmHg during the anorectal motility exam performed with high-resolution catheter (Given, Atlanta, GA). Normal resting pressures range from 50 to 100 mmHg. A flexible catheter with solid-state pressure transducers is placed in the anal canal and rectum to obtain standard pressure measurements	baseline, Months 3 and 12
Internal Anal sphincter (IAS) Pressure scores	Typical resting pressure in a healthy volunteer is 40 to 60 mmHg	baseline, Months 3 and 12
Rectal Anal Inhibitory Reflex (RAIR) Pressure scores	Low resting pressure is defined as <50 mmHg during the anorectal motility exam performed with high-resolution catheter (Given, Atlanta, GA). Normal resting pressures range from 50 to 100 mmHg. A flexible catheter with solid-state pressure transducers is placed in the anal canal and rectum to obtain Rectal Anal Inhibitory Reflex (RAIR)	baseline, Months 3 and 12
Fecal Incontinence Severity Index (FISI) scores	Participants who score closer to 61 are likely to have their quality of life severely impacted by the fecal incontinence they suffer from.	baseline, Months 3 and 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anorectal endoscopic ultrasound (EUS)	This standard procedure is performed with a rotating rectal probe without sedation or deep sedation	Months 3 and 12

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Catherine Matthews, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: bowel movements; low anal pressures; passive incontinence; sphincter muscle
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Fecal Incontinence; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: IRB00085606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No