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Own muscle cells injected into sphincter may curb fecal incontinence

NCT ID NCT04976153

Disease control Sponsor: Innovacell GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This Phase 3 trial tests whether injecting a patient's own muscle cells into the anal sphincter can reduce episodes of fecal incontinence. The study enrolls adults with urge incontinence due to a weak or damaged sphincter who have not improved with standard treatments. Participants receive either the cell injection or a placebo, and researchers track changes in incontinence frequency 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
Autologous muscle-derived cells
What this could lead to
If successful, this could offer a new treatment option for people with fecal incontinence who haven't improved with standard care.
What could go wrong
This is an advanced trial, but the treatment involves a surgical procedure and may not work for everyone. Risks include injection site reactions or lack of benefit.

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 290 people

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

Started

May 2022

Expected to finish

Mar 2028

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

Anyone

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: * Patients must be at least 18 years old * Patients who are mentally competent and able to understand all study requirements * Female patients of childbearing potential willing to use appropriate methods of contraception * Patient has symptoms of urge fecal incontinence with a disease duration of at least 6 months and did not improve sufficiently by conservative treatment performed for at least 3 months * Urge fecal incontinence episodes that occur more than twice a week * Maximal incremental voluntary squeeze pressure (increase to resting pressure) on anal manometry is 100mmHg or less in women and 150mmHg or less in men * 9\. Ultrasound of the anal canal showing intact external anal sphincter or a maximal overall extent of external anal sphincter injury and tear of 180 degrees Exclusion Criteria: * Patients for whom the investigator determines that FI has a different cause than external anal sphincter dysfunction. * Patients with global fragmentation of the external anal sphincter as assessed by anal canal ultrasound * Patients who underwent any anorectal surgery within 6 months before screening visit * Patients who underwent a total of two or more external anal sphincter-related surgeries * Patients who currently have anal fistulas or fissures or have recurrent anal fistulas or fissures * Patients with poorly controlled chronic constipation including obstructed defecation syndrome * Patients with indications against a surgery under anesthesia * Patients with a malignant disease not in remission for 5 years or more * Patients who have undergone radiation therapy of the bowel and pelvis * Patients who have undergone chemotherapy within last 5 years prior to study enrolment and/or chemotherapy related neuropathy of the bowel and pelvis * Patients with compromised immune system and/or rheumatic disease, and patients under immunosuppressive therapy * Patients with a diagnosis of chronic inflammatory bowel disease (e.g Crohn's disease, Colitis Ulcerosa) * Patients suffering from a disease which has not been resolved within 4 weeks prior to screening including fever and/or diarrhea of unknown reasons (4 weeks) * Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepatitis HCV, acute or chronic viral hepatitis HBV, active Syphilis or HTLV (tested upon risk assessment by investigator) * Patients diagnosed with any kind of skeletal muscle disease and/or neuronal disorders * Patients with severe myocardial disorders, irregular pulse or a pacemaker * Patients with implantations of metal components in the electrical stimulation treatment area * Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain * Patients with clinically relevant abnormal laboratory values judged by the responsible investigator as relevant for the study treatment

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence

As listed by the trial registrant

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

Fecal incontinence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    34 sites in 12 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • CHU Rennes - Hospital Pontchaillou

    RECRUITING

    Rennes, France

  • CHU de Rouen

    RECRUITING

    Rouen, France

  • Coloproctology Center Takano Hospital

    RECRUITING

    Kumamoto, Japan

  • Corporacio Sanitaria Parc Tauli

    RECRUITING

    Barcelona, Spain

  • Danderyd Sjukhus

    RECRUITING

    Danderyd, Sweden

  • Deaconess Hospital Group Croix Saint - Simon

    RECRUITING

    Paris, France, 75020, France

  • Fakultni nem. u sv. Anny v Brne

    RECRUITING

    Brno, Brno, Czechia

  • Heidelberg University, Medical Faculty Mannheim, Department of surgery

    RECRUITING

    Mannheim, Germany

  • Hiroshima Memorial Hospital

    RECRUITING

    Hiroshima, Japan

  • Hokkaido Railway Company JR Sapporo Hospital

    RECRUITING

    Sapporo, Hokkaido, 060-0033, Japan

  • Hosp. General Universitario Morales Meseguer

    RECRUITING

    Murcia, Spain

  • Hospital Bichat - Claude Bernard

    RECRUITING

    Paris, France, 75877, France

  • Hospital de Mataro

    RECRUITING

    Mataró, Spain

  • I.R.C.C.S. Policlinico San Donato

    RECRUITING

    San Donato Milanese, Milano, Italy

  • IATROS Medicinski Center

    RECRUITING

    Ljubljana, Osrednjeslovenska, 1000, Slovenia

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Italy

  • Japan Post Kyoto Teishin Hospital

    RECRUITING

    Kyoto, 604-8798, Japan

  • Jichi Medical University Hospital

    NOT_YET_RECRUITING

    Tochigi, Japan

  • Juntendo University Hospital

    RECRUITING

    Tokyo, Japan

  • Kurume Hospital

    RECRUITING

    Fukuoka, 839-0865, Japan

  • Landeskrankenhaus Hall in Tirol

    RECRUITING

    Hall in Tirol, 6060, Austria

  • Luis Garcia Florez

    RECRUITING

    Oviedo, Spain

  • Magen Darm Zentrum Wiener Platz

    RECRUITING

    Cologne, North Rhine-Westphalia, 51065, Germany

  • Matsushima Hospital

    RECRUITING

    Kanagawa, Japan

  • Medical Center Unimed EOOD

    RECRUITING

    Sevlievo, Bulgaria

  • Medical University Graz

    RECRUITING

    Graz, Austria

  • Meiwa Hospital

    RECRUITING

    Hyōgo, 663-8186, Japan

  • Skånes Universitetssjukhus, Malmo

    RECRUITING

    Malmö, Sweden, Sweden

  • St. Mary's Hospital

    RECRUITING

    London, United Kingdom

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

    RECRUITING

    Krakow, Poland

  • Teikyo University Chiba Medical Center

    RECRUITING

    Chiba, Japan

  • The Institute for the Care of Mother and Child

    RECRUITING

    Prague, Czechia

  • Tsujinaka Hospital, Coloproctological Surgery

    RECRUITING

    Chiba, 227-08771, Japan

  • Östersund sjukhus, Kirurgiska kliniken

    RECRUITING

    Östersund, Sweden, Sweden

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