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Muscle Regeneration
Muscle Fiber Fragment Injections for Bowel Incontinence
N/A
Recruiting
Led By Catherine Matthews, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants will undergo endoscopic anal ultrasound and demonstrate an anatomic defect of the anal sphincter complex of at least 30 degrees
Participants who have failed standard medical and surgical treatments for FI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 3 and 12
Awards & highlights
Study Summary
This trial is testing if muscle fiber fragments that contain muscle precursor cells can be used to regenerate functional anal sphincter muscle.
Who is the study for?
This trial is for adults with bowel incontinence lasting over a year, who've tried other treatments without success. They must have an anal sphincter defect and frequent incontinence episodes. Women should use birth control during the study. Excluded are those with bleeding disorders, rectal pain or diseases, recent cancer, certain infections like HIV/Hepatitis B/C, severe heart/lung/kidney conditions, uncontrolled diabetes, or recent childbirth.Check my eligibility
What is being tested?
The trial tests injections of Muscle Fiber Fragments (MFF) containing muscle precursor cells to repair the anal sphincter muscle and improve bowel control. Participants will receive these injections directly into their anal sphincter to see if it can regenerate functional muscle tissue.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, infection risk due to the procedure itself, allergic reactions to injected materials or anesthesia used during treatment; however specific side effects related to MFF injections will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My anal sphincter has a defect of at least 30 degrees confirmed by ultrasound.
Select...
My standard treatments for fecal incontinence have not worked.
Select...
I have had 4 or more episodes of losing control of my bowels in the last 2 weeks.
Select...
I am 18 years old or older.
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I have had symptoms for at least a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 3 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 3 and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)
Secondary outcome measures
Anorectal Manometry (ARM) Pressure scores
Change in Fecal Incontinence Quality of Life (FI-QOL) scores
Fecal Incontinence Severity Index (FISI) scores
+2 moreOther outcome measures
Anorectal endoscopic ultrasound (EUS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Muscle Fiber Fragment (MFF) injectionsExperimental Treatment1 Intervention
autologous muscle fiber fragment injections, harvested in an autologous fashion from the quadriceps muscle, for the treatment of Fecal Incontinence (FI) symptoms in men and women with a demonstrated anal sphincter defect and who have failed conservative treatments
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,234 Previous Clinical Trials
1,001,898 Total Patients Enrolled
Catherine Matthews, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
663 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have anemia, or my liver enzymes or bilirubin levels are higher than normal.I do not have severe heart, lung, kidney problems, or uncontrolled diabetes.I have had symptoms for at least a year.I have had injections to bulk up my internal anal sphincter.I have Hepatitis B, C, or HIV.I have existing pain in my anal or rectal area.I have symptoms like bleeding or pain due to anorectal conditions.You will undergo anorectal manometry (ARM) testing.I haven't had pelvic radiation, rectal issues, or certain anorectal treatments in the last year.I have a tumor in my anus or rectum.I have a nerve condition affecting my limbs or spinal cord.My anal sphincter has a defect of at least 30 degrees confirmed by ultrasound.My usual treatments for fecal incontinence didn't work.My standard treatments for fecal incontinence have not worked.I have had 4 or more episodes of losing control of my bowels in the last 2 weeks.My rectum has slipped outside its usual place.My vaginal prolapse extends beyond the hymen.I have ongoing severe diarrhea causing loss of bowel control.I have a bleeding disorder diagnosed and treated by a blood specialist.I will have a test to measure the strength of my rectum and anus.I have active inflammation in my rectum or have inflammatory bowel disease.I have current or past infections in my anal area.I am 18 years old or older.I have had symptoms for at least a year.My anal sphincter has a defect of at least 30 degrees confirmed by ultrasound.I have had 4 or more episodes of losing control of my bowels in the last 2 weeks.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Muscle Fiber Fragment (MFF) injections
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals enroll in this research initiative at this time?
"Based on the clinicaltrials.gov report, this medical trial is not presently seeking candidates. The initial posting occurred on December 1st 2022, and the latest update was made on September 26th 2022; nonetheless, 29 other trials are actively recruiting participants simultaneously."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Wake Forest University Health Sciences
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Wake Forest University Health Sciences: < 48 hours
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