Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury (NCT05776277)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (13 items).
Location: UC San Diego Health — La Jolla, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (25 Sites)
- UC San Diego Health — La Jolla, California
- UC Irvine Medical Center — Orange, California
- University of California, San Francisco - Center for Colorectal Surgery — San Francisco, California
- Prestige Medical Group — Tustin, California
- American Association of Female Pelvic Medicine — Westlake Village, California
- University of Florida Shands Hospital — Gainesville, Florida
- Healthcare Clinical Data, Inc. — Miami, Florida
- Orlando Health Colon & Rectal Institute — Orlando, Florida
- USF Health South Tampa Center for Advanced Healthcare — Tampa, Florida
- Colorectal Wellness Center — Fayetteville, Georgia
- University of Illinois — Chicago, Illinois
- Franciscan Health Indianapolis — Indianapolis, Indiana
- Ochsner Health — New Orleans, Louisiana
- Massachusetts General Hospital — Boston, Massachusetts
- Bennett Institute of Urogynecology and Incontinence — Grand Rapids, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Mayo Clinic — Rochester, Minnesota
- Washington University School of Medicine — St Louis, Missouri
- Rutgers, Robert Wood Johnson Medical School, Clinical Research Center — New Brunswick, New Jersey
- Westchester Medical Center — Hawthorne, New York
- The Mount Sinai Medical Center — New York, New York
- Weill Cornell Medicine — New York, New York
- Stony Brook University Hospital — Stony Brook, New York
- Cleveland Clinic Main Campus Crile Building — Cleveland, Ohio
- Rhode Island Hospital — Providence, Rhode Island
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.