Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Fecal Incontinence

In brief

This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10\^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury. Half of the participants will receive iltamiocel (injections with cells) and the other half will receive placebo.

Key facts

Study ID

NCT05776277

Run by

Cook MyoSite

People needed

200

Starts

2024-03-21

Expected to finish

2027-12-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult female ≥ 18 years of age who has primary symptoms of fecal incontinence (FI) for at least 12 months.
• 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.

You may not qualify if…

• Has an implanted stimulation neuromodulation system (sacral or tibial) and symptoms are unstable as determined by the physician.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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