RecruitingNot ApplicableNCT05396456

Autologous Muscle Fiber Fragment Injections

Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence

Sponsor

Wake Forest University Health Sciences

Enrollment

10 participants

Start Date

Jan 12, 2023

Study Type

INTERVENTIONAL

Conditions

Fecal Incontinence

Summary

To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria19

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

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Interventions

PROCEDUREMuscle Fiber Fragment (MFF) Injections

The participant will be treated with an injection of muscle fiber fragments into the external anal sphincter at 3, 6, 9 and 12 o'clock using a 21-gauge needle to a depth of 1-2 cm from the external skin using equal amounts in each quadrant.