Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury (NCT05776277)
A Two-stage, Randomized, Controlled Trial Comparing the Safety and Efficacy of Iltamiocel With Placebo in the Treatment of Female Participants With Chronic Fecal Incontinence and a History of Obstetric Anal Sphincter Injury (DigniFI)
🩺 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: Review the eligibility criteria below.
Location: UC San Diego Health — La Jolla, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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.
More studies in Fecal Incontinence
- Use of the LEVA® Pelvic Health System for Fecal Incontinence — Madison, Wisconsin
- Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence — Richmond, Virginia
- Autologous Muscle Fiber Fragment Injections — Winston-Salem, North Carolina
- Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury — Cleveland, Ohio
- Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence — Augusta, Georgia
Explore by condition: All Fecal Incontinence clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.