Autologous Muscle Fiber Fragment Injections
ConditionFecal Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Muscle Fiber Fragment (MFF) Injections
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
1Wake Forest University Health Sciences27157, Winston-SalemNorth Carolina, United States
Sponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Source ClinicalTrials.gov