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Recruiting NCT05396456

Autologous Muscle Fiber Fragment Injections

No phase Interventional Fecal Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Muscle Fiber Fragment (MFF) Injections.
Who it may be relevant to
Registry conditions: Fecal Incontinence. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence

Overview

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.

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]
  • Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score) [Time frame: Month 6]
  • Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score) [Time frame: Month 12]
Secondary outcome measures (5)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT05396456 · IRB00085606

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗