NCT05396456 Autologous Muscle Fiber Fragment Injections
| NCT ID | NCT05396456 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Fecal Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-01-12 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2023-01-12 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
Eligibility Criteria
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
Contact & Investigator
Catherine Matthews, MD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05396456 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fecal Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05396456 currently recruiting?
Yes, NCT05396456 is actively recruiting participants. Contact the research team at Maryclare.Day@advocatehealth.org for enrollment information.
Where is the NCT05396456 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT05396456 clinical trial?
NCT05396456 is sponsored by Wake Forest University Health Sciences. The principal investigator is Catherine Matthews, MD at Wake Forest University Health Sciences. The trial plans to enroll 10 participants.