Autologous Muscle Fiber Fragment Injections

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · May 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with fecal incontinence, which is when someone has difficulty controlling their bowel movements. The researchers are exploring whether injecting small pieces of muscle fibers that contain special cells, called muscle precursor cells, can help regenerate the muscle responsible for controlling bowel movements. The goal is to improve the ability to control these movements and enhance the quality of life for participants.

To be eligible for this trial, participants need to be at least 18 years old and experience at least four episodes of fecal incontinence every two weeks. They should have had symptoms for at least a year and have not found relief from standard treatments. Participants will undergo some tests to assess their condition before receiving the treatment. It’s important to note that this study is open to all genders, but those with certain health issues, like active infections or specific gastrointestinal problems, will not be able to participate. If you or someone you know is struggling with this condition, this trial could offer a potential new option for treatment.

Gender

ALL

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