What side effects are associated with this type of intervention?

Common treatments for bowel incontinence include dietary changes, medications, pelvic floor exercises, and surgical interventions. Treatments similar to the trial involving muscle fiber fragments containing muscle precursor cells focus on regenerating muscle tissue. Known side effects of such regenerative therapies can include local inflammation, infection at the injection site, and potential immune reactions. Additionally, there may be risks associated with the procedure itself, such as pain or discomfort during and after the treatment.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments for bowel incontinence that directly involve muscle regeneration using muscle fiber fragments containing muscle precursor cells. Generally, treatments for bowel incontinence include medications, dietary changes, pelvic floor exercises, and surgical interventions. For muscle regeneration, therapies such as autologous muscle precursor cell injections have shown promise in experimental studies for restoring sphincter function, but these are not yet standard FDA-approved treatments.

What other types of research exist?

Promising novel alternatives for the treatment of bowel incontinence in 2024 include: 1) Stem cell therapies, particularly those using mesenchymal stem cells (MSCs) which have shown potential in tissue regeneration and repair. 2) Platelet-rich plasma (PRP) injections, which have been explored for their regenerative properties in muscle and tendon injuries. 3) Eteplirsen, a drug that has shown efficacy in increasing dystrophin production in muscular dystrophy, may have potential applications in muscle regeneration for bowel incontinence. These alternatives are still under investigation but show promise based on current research.

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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

Must not have

Participants with anemia (hemoglobin <10g, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 times normal) or increased bilirubin >1.5mg/dl

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 3 and 12

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to regenerate damaged anal sphincter muscles using small pieces of muscle that contain special cells. These pieces are injected into the damaged area to grow new muscle and restore function by connecting with the body's blood vessels and nerves.

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.

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.

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 below

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My anal sphincter has a defect of at least 30 degrees confirmed by ultrasound.

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My standard treatments for fecal incontinence have not worked.

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I have had 4 or more episodes of losing control of my bowels in the last 2 weeks.

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I am 18 years old or older.

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I have had symptoms for at least a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have anemia, or my liver enzymes or bilirubin levels are higher than normal.

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I do not have severe heart, lung, kidney problems, or uncontrolled diabetes.

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I have had injections to bulk up my internal anal sphincter.

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I have Hepatitis B, C, or HIV.

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I have existing pain in my anal or rectal area.

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I have symptoms like bleeding or pain due to anorectal conditions.

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I haven't had pelvic radiation, rectal issues, or certain anorectal treatments in the last year.

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I have a tumor in my anus or rectum.

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I have a nerve condition affecting my limbs or spinal cord.

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My rectum has slipped outside its usual place.

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My vaginal prolapse extends beyond the hymen.

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I have ongoing severe diarrhea causing loss of bowel control.

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I have a bleeding disorder diagnosed and treated by a blood specialist.

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I have active inflammation in my rectum or have inflammatory bowel disease.

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I have current or past infections in my anal area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 3 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 3 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 3 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score)

Secondary study objectives

Anorectal Manometry (ARM) Pressure scores

Change in Fecal Incontinence Quality of Life (FI-QOL) scores

Fecal Incontinence Severity Index (FISI) scores

+2 more

Other study objectives

Anorectal endoscopic ultrasound (EUS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bowel incontinence include biofeedback, medications, and surgical interventions. A promising treatment under investigation involves the use of autologous muscle fiber fragments containing muscle precursor cells (MPCs). This method aims to regenerate functional anal sphincter muscle by utilizing the inherent regenerative capabilities of MPCs, which proliferate and fuse to form new muscle fibers. This is particularly significant for bowel incontinence patients as it addresses the root cause of muscle weakness or damage, potentially restoring normal sphincter function and improving quality of life.

Regenerating the Anal Sphincter: Cytokines, Stem Cells, or Both?Contribution of minced muscle graft progenitor cells to muscle fiber formation after volumetric muscle loss injury in wild-type and immune deficient mice.The effect of age and medical comorbidities on in vitro myoblast expansion in women with and without pelvic organ prolapse.