Actively Recruiting
Autologous Muscle Fiber Fragment Injections
Led by Wake Forest University Health Sciences · Updated on 2026-02-27
10
Participants Needed
1
Research Sites
359 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
CONDITIONS
Official 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 Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS)
- Symptoms present for at least 12 months
- Have failed standard medical and surgical treatments for fecal incontinence
- Willing to undergo anorectal manometry testing
- Willing to have endoscopic anal ultrasound showing at least 30 degrees anatomic defect of the anal sphincter complex
- Women of childbearing potential must agree to use acceptable contraceptives during the study
You will not qualify if you...
- Symptomatic anorectal diseases such as hemorrhoid disease, anal fissure, or fistula causing symptoms like bleeding, swelling, pain, or drainage
- Pre-existing anorectal pain from any cause
- Incontinence of flatus only
- Chronic watery diarrhea as the main cause of fecal incontinence
- Acute or chronic anorectal infections including proctitis, recurrent abscesses, or fistulae
- Presence of anorectal tumors
- Active proctitis or inflammatory bowel disease
- Previous injections of internal anal sphincter with bulking agents
- Need for immunosuppression or history of malignant disease within 3 years
- Diagnosed bleeding disorders treated by a hematologist
- History of pelvic radiation, rectal prolapse, anorectal malformations, recent anorectal surgery within 12 months, or treatments like injection or infrared coagulation for hemorrhoids
- Neurologic diseases with 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 requiring home oxygen, abnormal kidney function, or uncontrolled diabetes
- Anemia with hemoglobin less than 10g, elevated liver enzymes more than twice normal, or increased bilirubin above 1.5mg/dl
- Positive for Hepatitis B or C, or HIV-1 or 2
- Rectal or vaginal prolapse beyond the hymen
- Unable to understand informed consent even with a medical translator
AI-Screening
AI-Powered Screening
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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
CONTACT
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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