RECRUITING

Autologous Muscle Fiber Fragment Injections

Conditions

Fecal Incontinence low anal pressures passive incontinence bowel movements sphincter muscle

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)

Official Title

Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence

Quick Facts

Study Start:2023-01-12

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05396456

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Mary-Clare Day, RN, BSN

CONTACT

336.713.1343

mday@wakehealth.edu

Principal Investigator

Catherine Matthews, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Catherine Matthews, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-12

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-01-12

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

low anal pressures
passive incontinence
bowel movements
sphincter muscle

Additional Relevant MeSH Terms

Fecal Incontinence