NCT05396456 · Wake Forest University Health Sciences
Autologous Muscle Fiber Fragment Injections
What this study is about
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
View original scientific description
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
Interventions
PROCEDURE
Muscle 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.
Primary outcome measures
Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)
Time frame: Month 3
fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence
Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)
Time frame: Month 6
fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence
Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)
Time frame: Month 12
fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 potential must use acceptable contraceptives during this study
Exclusion criteria
- 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
Where
- Winston-Salem, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations