Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
NCT ID: NCT05776277
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2024-03-21
2027-12-31
Brief Summary
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Detailed Description
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This is a double-blind randomized study, which means neither the participant, nor the study doctor will know which treatment group the participant will be in. Participants who are randomly chosen to receive injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Iltamiocel
Iltamiocel
Single external anal sphincter (EAS) injection of 300 x 10\^6 cells.
Placebo
Placebo
Placebo control is the vehicle solution used for the study product.
Interventions
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Iltamiocel
Single external anal sphincter (EAS) injection of 300 x 10\^6 cells.
Placebo
Placebo control is the vehicle solution used for the study product.
Eligibility Criteria
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Inclusion Criteria
* History of obstetric anal sphincter injury (e.g., episiotomy, perineal tear).
* Failed conservative treatment (e.g., dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 6 months prior to enrollment.
* Must be willing and able to comply with the study procedures, be mentally competent and able to understand all study requirements, and must agree to read and sign the informed consent form prior to any study-related procedures.
Exclusion Criteria
* Is pregnant or planning to become pregnant within the next 2 years.
* Has known rectal sensory dysfunction (e.g., hypersensitivity or hyposensitivity).
* Has an obstetric anal sphincter injury (e.g., episiotomy, perineal tear) within 1 year previous to study enrollment.
* Patient BMI ≥ 38.
* Has a history of cancer in the colorectal or pelvic organs within 5 years prior to study enrollment.
* Any cancer that has undergone treatment within the past 12 months.
* Has an established diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis) or current intestinal stoma.
* Has grade III/IV hemorrhoids.
* Has chronic diarrhea at the time of Screening.
* Has chronic constipation at the time of Screening.
* Has significant pelvic floor prolapse, significant genitourinary prolapse beyond the introitus, significant symptomatic rectocele, or evidence of significant rectal evacuation disorder leading to post-defecatory leakage.
18 Years
FEMALE
No
Sponsors
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Cook MyoSite
INDUSTRY
Responsible Party
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Principal Investigators
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Ron Jankowski, PhD
Role: STUDY_DIRECTOR
Cook Myosite, Inc.
Locations
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UC San Diego Health
La Jolla, California, United States
UC Irvine Medical Center
Orange, California, United States
University of California, San Francisco - Center for Colorectal Surgery
San Francisco, California, United States
Prestige Medical Group
Tustin, California, United States
American Association of Female Pelvic Medicine
Westlake Village, California, United States
University of Florida Shands Hospital
Gainesville, Florida, United States
Healthcare Clinical Data, Inc.
Miami, Florida, United States
Orlando Health Colon & Rectal Institute
Orlando, Florida, United States
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, United States
Colorectal Wellness Center
Fayetteville, Georgia, United States
University of Illinois
Chicago, Illinois, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Ochsner Health
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Bennett Institute of Urogynecology and Incontinence
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers, Robert Wood Johnson Medical School, Clinical Research Center
New Brunswick, New Jersey, United States
Westchester Medical Center
Hawthorne, New York, United States
The Mount Sinai Medical Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Cleveland Clinic Main Campus Crile Building
Cleveland, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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22-01
Identifier Type: -
Identifier Source: org_study_id