Autologous Muscle Fiber Fragment Injections

NCT ID: NCT05396456

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-12
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Fecal Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Muscle Fiber Fragment (MFF) injections

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

Group Type: EXPERIMENTAL

Muscle Fiber Fragment (MFF) Injections

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Matthews, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary-Clare Day, RN, BSN

Role: CONTACT

mday@wakehealth.edu

336.713.1343

Facility Contacts

Mary-Clare Day, RN, BSN

Role: primary

mday@wakehealth.edu

336-713-1343

Other Identifiers

IRB00085606

Identifier Type: -

Identifier Source: org_study_id