Could a single injection fix bowel leakage after childbirth? new trial aims to find out
NCT ID NCT05776277
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests a single injection of muscle cells (iltamiocel) into the anal sphincter to reduce accidental bowel leakage in women who have had a childbirth injury. About 200 women will receive either the cell injection or a placebo. The study measures how often leakage episodes occur over time.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
iltamiocel (muscle cells injected into the anal sphincter)
What this could lead to
If it works, this could offer a new, non-surgical treatment to reduce accidental bowel leakage in women who have had a childbirth injury.
What could go wrong
This is a Phase 3 trial, but it is still experimental. The treatment may not work better than placebo, and there are risks from the injection procedure, such as infection or pain.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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American Association of Female Pelvic Medicine
Westlake Village, California, 91361, United States
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Bennett Institute of Urogynecology and Incontinence
Grand Rapids, Michigan, 49546, United States
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Cleveland Clinic Main Campus Crile Building
Cleveland, Ohio, 44195, United States
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Colorectal Wellness Center
Fayetteville, Georgia, 30214, United States
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Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
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Healthcare Clinical Data, Inc.
Miami, Florida, 33161, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Ochsner Health
New Orleans, Louisiana, 70121, United States
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Orlando Health Colon & Rectal Institute
Orlando, Florida, 32806, United States
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Prestige Medical Group
Tustin, California, 92780, United States
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Rhode Island Hospital
Providence, Rhode Island, 02903, United States
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Rutgers, Robert Wood Johnson Medical School, Clinical Research Center
New Brunswick, New Jersey, 08901, United States
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Stony Brook University Hospital
Stony Brook, New York, 11794, United States
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The Mount Sinai Medical Center
New York, New York, 10029, United States
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UC Irvine Medical Center
Orange, California, 92868, United States
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UC San Diego Health
La Jolla, California, 92122, United States
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USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, 33606, United States
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University of California, San Francisco - Center for Colorectal Surgery
San Francisco, California, 94158, United States
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University of Florida Shands Hospital
Gainesville, Florida, 32610, United States
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University of Illinois
Chicago, Illinois, 60612, United States
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University of Minnesota
Minneapolis, Minnesota, 55455, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Weill Cornell Medicine
New York, New York, 10065, United States
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Westchester Medical Center
Hawthorne, New York, 10532, United States