Wake Forest University Health Sciences
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
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 fragments would integrate into the host vascular and neural network.
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…
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.
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