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New treatment option for Fecal Incontinence
Official title Autologous Muscle Fiber Fragment Injections
ClinicalTrials.gov ID: NCT05396456
What this study is testing
- What it's testing
- To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- participants with symptomatic anorectal disease including symptomatic hemorrhoid disease, anal fissure or fistula causing symptoms such as bleeding...
- 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
See the full eligibility 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...
- 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...
- participants with anemia (hemoglobin \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.