Actively Recruiting
Autologous Muscle Fiber Fragment Injections for Fecal Incontinence Treatment
Led by Wake Forest University Health Sciences · Updated on 2026-02-27
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial focuses on treating fecal incontinence by regenerating functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells. Researchers are exploring whether these fragments can successfully integrate into the host muscle tissue, vascular, and neural networks to improve symptoms in men and women who have anal sphincter defects and have not responded to standard treatments. Participants will receive injections of muscle fiber fragments obtained from their own quadriceps muscle. These injections are administered into the external anal sphincter at four locations (3, 6, 9, and 12 o'clock) using a fine needle. The treatment schedule and procedure details are designed to encourage integration of the fragments with the participant's native muscle fibers. During the study, participants will be monitored through various assessments including scoring their fecal incontinence severity using the Cleveland Clinic Fecal Incontinence Severity Scoring System at 3, 6, and 12 months. Additional evaluations include quality of life questionnaires, anorectal manometry pressure tests, and anal ultrasound imaging. Safety and treatment effects will be followed over time, with the total participation duration extending up to one year after treatment.
CONDITIONS
Brief Title
Autologous Muscle Fiber Fragment Injections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Experience 4 or more fecal incontinence episodes per 2 week period
- Score greater than 10 on the Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS)
- Have had fecal incontinence symptoms for at least 12 months
- Failed standard medical and surgical treatments for fecal incontinence
- Willing to undergo anorectal manometry testing
- Demonstrate an anatomic defect of the anal sphincter complex of at least 30 degrees on endoscopic anal ultrasound
- Women of childbearing potential must use acceptable contraceptives during the study
You will not qualify if you...
- Symptomatic anorectal diseases such as symptomatic hemorrhoids, anal fissure, or fistula causing bleeding, pain, swelling, or drainage
- Pre-existing anorectal pain of any cause
- Incontinence of flatus only
- Chronic watery diarrhea as the primary cause of fecal incontinence
- Acute or chronic anorectal infections including proctitis or recurrent abscesses
- Presence of anorectal tumors
- Active proctitis or inflammatory bowel disease
- Previous injection of internal anal sphincter with bulking agents
- Need for immunosuppression or malignant disease within 3 years
- Diagnosed and treated bleeding disorders
- History of pelvic radiation, rectal prolapse, anorectal malformations, or recent anorectal surgery within 12 months
- Previous treatments for hemorrhoids using injection or infrared coagulation
- Neurologic diseases causing significant peripheral neuropathy or spinal cord dysfunction
- Women who are pregnant, breastfeeding, or have had a child within the last year
- History of unstable cardiac or pulmonary function, abnormal kidney function, or uncontrolled diabetes
- Anemia or abnormal liver function tests
- Hepatitis B or C, or human immunodeficiency virus (HIV)-1 or 2 infection
- Vaginal prolapse beyond the hymen
- Unable to understand informed consent even with a medical translator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session with injections administered at 3, 6, 9, and 12 o'clock positions
Participants receive autologous muscle fiber fragment injections into the external anal sphincter to treat fecal incontinence symptoms.
1 treatment visit (in-person)
Duration - 12 months
Participants are monitored for treatment effectiveness and safety with scheduled assessments over 12 months.
Visits at baseline, Month 3, Month 6, and Month 12 for clinical assessments and outcome measurements
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
M
Mary-Clare Day, RN, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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