Status:
RECRUITING
Autologous Muscle Fiber Fragment Injections
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
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 fragmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05396456
Start Date
January 12 2023
End Date
December 1 2026
Last Update
March 27 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157