Injections of muscle fiber fragments to treat fecal incontinence
Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence
This study is testing if injecting muscle fiber fragments can help people with fecal incontinence by improving the strength and function of their anal sphincter muscle.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05396456 on ClinicalTrials.gov |
What this trial studies
This study aims to regenerate functional anal sphincter muscle by injecting muscle fiber fragments that contain muscle precursor cells (MPCs). The hypothesis is that these fragments will effectively integrate into the host muscle tissue, aligning with the natural fiber direction, and will connect with the host's vascular and neural networks. Participants will be evaluated for their eligibility based on specific criteria related to fecal incontinence severity and anatomical defects. The intervention involves administering muscle fiber fragment injections to eligible participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who experience frequent fecal incontinence episodes and have not responded to standard treatments.
Not a fit: Patients with certain anorectal diseases, pre-existing pain, or those who only experience flatus incontinence may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bowel control and quality of life for patients suffering from fecal incontinence.
How similar studies have performed: While this approach is innovative, similar studies exploring muscle regeneration techniques have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Catherine Matthews, MD — Wake Forest University Health Sciences
- Study coordinator: Mary-Clare Day, RN, BSN
- Email: Maryclare.Day@advocatehealth.org
- Phone: 336.713.1343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.