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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Muscle Fiber Fragment (MFF) Injections
Procedure/SurgeryThe 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Muscle Fiber Fragment (MFF) injectionsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)
fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence
Time frame
Month 32
Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)
fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence
Time frame
Month 63
Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)
fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence
Time frame
Month 12Secondary outcomes
1
Change in Fecal Incontinence Quality of Life (FI-QOL) scores
The Fecal Incontinence Quality of Life Scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items), Coping/Behavior (9 items), Depression/Self-Perception (7 items), and Embarrassment (3 items).
Time frame
baseline, Months 3 and 122
Anorectal Manometry (ARM) Pressure scores
Low resting pressure is defined as \<50 mmHg during the anorectal motility exam performed with high-resolution catheter (Given, Atlanta, GA). Normal resting pressures range from 50 to 100 mmHg. A flexible catheter with solid-state pressure transducers is placed in the anal canal and rectum to obtain standard pressure measurements
Time frame
baseline, Months 3 and 123
Internal Anal sphincter (IAS) Pressure scores
Typical resting pressure in a healthy volunteer is 40 to 60 mmHg
Time frame
baseline, Months 3 and 124
Rectal Anal Inhibitory Reflex (RAIR) Pressure scores
Low resting pressure is defined as \<50 mmHg during the anorectal motility exam performed with high-resolution catheter (Given, Atlanta, GA). Normal resting pressures range from 50 to 100 mmHg. A flexible catheter with solid-state pressure transducers is placed in the anal canal and rectum to obtain Rectal Anal Inhibitory Reflex (RAIR)
Time frame
baseline, Months 3 and 12Other outcomes
1
Anorectal endoscopic ultrasound (EUS)
This standard procedure is performed with a rotating rectal probe without sedation or deep sedation
Time frame
Months 3 and 12Sponsors and contacts
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Source ClinicalTrials.gov