Fecal IncontinenceNCT05396456
Autologous Muscle Fiber Fragment Injections
A study testing Muscle Fiber Fragment (MFF) Injections in people with Fecal Incontinence, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Muscle Fiber Fragment (MFF) Injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2023to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Mary-Clare Day, RN, BSN, 336-713-1343, Maryclare.Day@advocatehealth.org
About this study
Official title: Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
Read the detailed description
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.
- Conditions
- Fecal Incontinence
- Being tested
- Muscle Fiber Fragment (MFF) Injections
- Keywords
- low anal pressures, passive incontinence, bowel movements, sphincter muscle
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Fiber Fragment (MFF) InjectionsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Muscle Fiber Fragment (MFF) injections | Experimental | 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 Receives: Procedure: Muscle Fiber Fragment (MFF) Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 3
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
Measured: Month 6
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
Measured: Month 12
Secondary outcomes (5)
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).
Measured: baseline, Months 3 and 12
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
Measured: baseline, Months 3 and 12
Internal Anal sphincter (IAS) Pressure scores
Typical resting pressure in a healthy volunteer is 40 to 60 mmHg
Measured: baseline, Months 3 and 12
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)
Measured: baseline, Months 3 and 12
Fecal Incontinence Severity Index (FISI) scores
Participants who score closer to 61 are likely to have their quality of life severely impacted by the fecal incontinence they suffer from.
Measured: baseline, Months 3 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start12 Jan 2023
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with refractory Fecal Incontinence (FI) will be identified from the Atrium Wake Forest Baptist Health outpatient Gastroenterology, Urogynecology and Colorectal Surgery clinics.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Matthews, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396456
- Sponsor's protocol ID
- IRB00085606
- Status last verified
- Feb 2026
- First submitted
- 25 May 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence
- ClinicalTrials.gov ID
- NCT05396456
- Acronym / sponsor ID
- IRB00085606
- Conditions
- Fecal Incontinence
- Keywords
- low anal pressures, passive incontinence, bowel movements, sphincter muscle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with refractory Fecal Incontinence (FI) will be identified from the Atrium Wake Forest Baptist Health outpatient Gastroenterology, Urogynecology and Colorectal Surgery clinics.
| Arm | Type | Receives |
|---|---|---|
| Muscle Fiber Fragment (MFF) injections | Experimental | Procedure: Muscle Fiber Fragment (MFF) Injectionsautologous 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle Fiber Fragment (MFF) InjectionsThe 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. | Procedure or surgery | Muscle Fiber Fragment (MFF) injections |
Primary outcome
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
5 secondary outcomes
Change in Fecal Incontinence Quality of Life (FI-QOL) scores
Time frame: baseline, Months 3 and 12
Anorectal Manometry (ARM) Pressure scores
Time frame: baseline, Months 3 and 12
Internal Anal sphincter (IAS) Pressure scores
Time frame: baseline, Months 3 and 12
Rectal Anal Inhibitory Reflex (RAIR) Pressure scores
Time frame: baseline, Months 3 and 12
Fecal Incontinence Severity Index (FISI) scores
Time frame: baseline, Months 3 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Matthews, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Fiber Fragment (MFF) Injections in people with Fecal Incontinence, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary-Clare Day, RN, BSN (336.713.1343, Maryclare.Day@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score) (time frame: Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.