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Could a single injection fix bowel leakage after childbirth? new trial aims to find out

NCT ID NCT05776277

Disease control Sponsor: Cook MyoSite Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 22, 2026 · Updated 3 times

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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. * 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.

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Conditions

The condition(s) this trial relates to.

digestive system disorder Encopresis Fecal Incontinence intestinal disorder rectal disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fecal incontinence

Contacts and locations

Locations

  • American Association of Female Pelvic Medicine

    Westlake Village, California, 91361, United States

  • Bennett Institute of Urogynecology and Incontinence

    Grand Rapids, Michigan, 49546, United States

  • Cleveland Clinic Main Campus Crile Building

    Cleveland, Ohio, 44195, United States

  • Colorectal Wellness Center

    Fayetteville, Georgia, 30214, United States

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237, United States

  • Healthcare Clinical Data, Inc.

    Miami, Florida, 33161, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Ochsner Health

    New Orleans, Louisiana, 70121, United States

  • Orlando Health Colon & Rectal Institute

    Orlando, Florida, 32806, United States

  • Prestige Medical Group

    Tustin, California, 92780, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Rutgers, Robert Wood Johnson Medical School, Clinical Research Center

    New Brunswick, New Jersey, 08901, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • The Mount Sinai Medical Center

    New York, New York, 10029, United States

  • UC Irvine Medical Center

    Orange, California, 92868, United States

  • UC San Diego Health

    La Jolla, California, 92122, United States

  • USF Health South Tampa Center for Advanced Healthcare

    Tampa, Florida, 33606, United States

  • University of California, San Francisco - Center for Colorectal Surgery

    San Francisco, California, 94158, United States

  • University of Florida Shands Hospital

    Gainesville, Florida, 32610, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

  • Westchester Medical Center

    Hawthorne, New York, 10532, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.