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Study on ICEF15 for Treating Fecal Incontinence in Patients with Anal Sphincter Dysfunction

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as fecal incontinence, which affects both men and women. Fecal incontinence is when a person has difficulty controlling their bowel movements, leading to unexpected leakage. The study is testing a new treatment called ICEF15, which involves using special cells taken from a patient's own muscles, known as autologous Skeletal Derived Muscle Cells (aSDMC). These cells are injected into the muscles to help improve control over bowel movements.

The purpose of the study is to evaluate how effective and safe the ICEF15 treatment is for people with fecal incontinence caused by problems with the external anal sphincter, a muscle that helps control bowel movements. Participants in the study will receive either the ICEF15 treatment or a placebo, which is a solution that does not contain the active treatment. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will receive injections and will be monitored over a period of time to see if there is a reduction in the frequency of incontinence episodes. The study aims to determine if the treatment can reduce these episodes by at least 50% compared to before the treatment started. This research is important for finding new ways to help people manage fecal incontinence and improve their quality of life.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The study begins with an initial assessment to confirm eligibility. This includes a review of symptoms related to fecal incontinence and a medical history check.

    Eligibility criteria include being 18 years or older, having symptoms of urge fecal incontinence for at least 6 months, and having tried conservative treatment for at least 3 months without sufficient improvement.

  2. Step 2

    Informed consent

    Participants must read and sign an Informed Consent form to confirm understanding and agreement to participate in the study.

  3. Step 3

    Baseline period

    Participants will maintain a bowel diary to record the frequency of incontinence episodes. This period helps establish a baseline for comparison with future results.

  4. Step 4

    Randomization and treatment

    Participants are randomly assigned to receive either the ICEF15 injection or a placebo. Both are administered via intramuscular injection.

    The purpose of this step is to evaluate the effectiveness and safety of the ICEF15 treatment compared to the placebo.

  5. Step 5

    Follow-up assessments

    Regular follow-up visits are scheduled to monitor the participant's condition and any changes in the frequency of incontinence episodes.

    Participants continue to maintain a bowel diary to track the frequency of episodes, which will be compared to the baseline data.

  6. Step 6

    Final assessment

    The study concludes with a final assessment to evaluate the overall effectiveness and safety of the treatment.

    The primary measure of success is the change in frequency of incontinence episodes from the baseline period to the end of the study.

Who can join the trial?

9 criteria

  • Patients must be **18 years of age or older**.
  • Patients must be **willing and able** to follow the study procedures.
  • Patients must be **mentally competent** and able to understand all study requirements.
  • Patients must agree to **read and sign the Informed Consent (IC) form** before any study-related procedures.
  • Female patients who can have children must be willing to use **appropriate methods of contraception**. They can only join the study after a confirmed menstrual period and a negative pregnancy test.
  • Patients must have symptoms of **urge fecal incontinence** for at least **6 months** but not more than **10 years**, and these symptoms must not have improved enough with conservative treatment done for at least **3 months**.
  • Patients must have **urge fecal incontinence episodes** that are more than just "traces" and occur more than **twice a week**.
  • For women, the **maximal incremental voluntary squeeze pressure** on anal manometry must be **100 mmHg or less**. For men, it must be **150 mmHg or less**. Anal manometry is a test that measures the strength of the muscles in the anus.
  • An **ultrasound of the anal canal** must show an intact external anal sphincter or a maximum overall extent of external anal sphincter injury and tear of **180 degrees**. The external anal sphincter is a muscle that helps control bowel movements.

Who cannot join the trial?

8 criteria

  • Patients who have a condition other than fecal incontinence caused by problems with the external anal sphincter. The external anal sphincter is a muscle that helps control bowel movements.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who have other medical conditions that might interfere with the study or its results.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had recent surgery or medical procedures that could affect the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have allergies or reactions to the study treatment or its components.
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Investigated drugs

ICEF15 is a therapy involving the implantation of skeletal muscle-derived cells. This treatment is being studied for its potential to help patients who have fecal incontinence, which is a condition where there is difficulty controlling bowel movements. The therapy aims to improve the function of the external anal sphincter, which may be weakened or disrupted, leading to incontinence. The study is focused on evaluating how effective and safe this therapy is for patients experiencing these symptoms.

What is already known about the treatment

ICEF15 – ICEF15 is administered through implantation of skeletal muscle-derived cells, specifically targeting the treatment of fecal incontinence in both female and male patients. Currently, it is in a phase III clinical trial, which is a critical stage in medical research to evaluate its efficacy and safety. The main therapeutic indication for ICEF15 is to address fecal incontinence caused by dysfunction of the external anal sphincter due to its disruption or weakness. At the molecular level, the mechanism of action involves the integration and regeneration of muscle cells to restore sphincter function. ICEF15 falls under the pharmacological classification of regenerative medicine, focusing on cell-based therapies to repair or replace damaged tissues.

Investigated diseases

Fecal Incontinence – Fecal incontinence is a condition where an individual loses control over bowel movements, leading to the involuntary passage of stool. It can occur due to dysfunction or weakness of the external anal sphincter, often resulting from damage or disruption. This condition can affect both men and women and may vary in severity, from occasional leakage to a complete loss of bowel control. The progression of fecal incontinence can lead to increased frequency of incontinence episodes, impacting daily activities and quality of life. It is often associated with other conditions that affect the pelvic floor muscles or nerves.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518243-38-00Protocol codeIC-01-02-5-009Estimated enrolment286 patientsSponsorInnovacell GmbH

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