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Study on the Safety and Effectiveness of Mesenchymal Stem Cells for Treating Intestinal Strictures in Crohn's Disease Patients

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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 the effects of a treatment for Crohn's disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain and difficulty digesting food. The treatment being tested involves the use of Mesenchymal Stem Cells (MSC), which are special cells derived from bone marrow. These cells are injected locally as a suspension to see if they can help improve the condition of intestinal strictures, which are narrowings in the intestines that can occur in people with Crohn's disease.

The purpose of the study is to assess whether the local injection of these stem cells, combined with a procedure called endoscopic dilation, is safe and effective in treating these strictures. Endoscopic dilation is a technique used to widen the narrowed areas in the intestines. The study will compare the effects of the MSC treatment to a placebo, which is a substance with no active therapeutic effect, to determine if the stem cells provide any additional benefit.

Participants in the study will receive either the MSC treatment or the placebo through a single local injection. The study will monitor participants over a period of time to observe any changes in their symptoms and the condition of their intestinal strictures. The goal is to see if the treatment can reduce the need for further medical interventions, such as additional endoscopic procedures or surgery, and improve the overall quality of life for those with Crohn's disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes verifying a diagnosis of Crohn's disease for more than 6 months, stable treatment for 4 months, and the presence of a stricture that meets specific criteria.

    A Magnetic Resonance Enterography with Dynamic-Contrast-Enhancement (DCE-MRI) is required to assess the stricture.

  2. Step 2

    Consent and preparation

    Participation requires signing an informed consent form. This confirms understanding and acceptance of the study protocol.

    Preparation for the procedure involves ensuring the stricture is accessible by ileo-colonoscopy and is eligible for endoscopic dilation.

  3. Step 3

    Endoscopic dilation and injection

    The procedure involves endoscopic dilation of the stricture. This is followed by a local injection of mesenchymal stem cells (MSC) or a placebo.

    The MSCs are allogeneic bone marrow-derived mesenchymal adult stromal cells, expanded outside the body. The placebo consists of a solution with 75% NaCL 0.9% and 25% HSA 20% (Human serum albumin).

  4. Step 4

    Follow-up and monitoring

    Monitoring occurs up to week 48 to evaluate safety and efficacy. This includes checking for any adverse events and assessing clinical response to the treatment.

    Patient Reported Outcomes (PROs) and Stenosis Patient Reported Outcomes (S-PROs) are evaluated at weeks 0, 24, and 48. Endoscopic and radiological parameters are also measured at these intervals.

  5. Step 5

    Completion of trial

    The trial is estimated to end by August 31, 2025. Final assessments will determine the overall safety and efficacy of the treatment.

    The primary focus is on the occurrence of adverse events and the clinical response to the stricture without the need for additional interventions.

Who can join the trial?

9 criteria

  • Patient must be **18 years or older** and have been diagnosed with **Crohn's Disease** for more than 6 months.
  • The treatment for Crohn's Disease should be stable for the last **4 months**.
  • There must be a **stricture**, which is a narrowing in the bowel, that meets specific criteria:
    • Localized narrowing where the bowel is at least **50% smaller** than the healthy part next to it.
    • The bowel wall is **thicker** by 25% compared to the healthy part next to it.
    • There is a **dilation** before the narrowing, meaning the bowel is wider than **3 cm**.
    • The stricture should cause **symptoms** like abdominal pain after eating and limit the amount or type of food you can eat.
    • The stricture should be reachable by a procedure called **ileo-colonoscopy** and should not allow the passage of the scope. It should be less than **5 cm** long and suitable for a procedure called **endoscopic dilation**.
    • The patient must agree to the study and sign a document called **informed consent**.
    • The patient should be able to undergo a special imaging test called **Magnetic Resonance Enterography with Dynamic-Contrast-Enhancement (DCE-MRI)**.

Who cannot join the trial?

3 criteria

  • Patients who do not have Crohn's disease cannot participate. Crohn's disease is a condition that affects the digestive system.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection.
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Investigated drugs

Mesenchymal Stem Cells are special cells that can develop into different types of cells in the body. In this trial, they are injected locally into the area of the intestine that has become narrowed due to Crohn's disease. The goal is to see if these cells can help heal the area and improve the outcome for patients by reducing the narrowing and preventing future complications.

What is already known about the treatment

Mesenchymal Stem Cells – This treatment involves the local injection of mesenchymal stem cells, typically administered directly into the affected area during an endoscopic procedure. Currently, this approach is being studied in clinical trials to determine its safety and effectiveness, particularly for patients with Crohn's disease who experience intestinal strictures. The main therapeutic indication is to alleviate these strictures, potentially improving patient outcomes. At the molecular level, mesenchymal stem cells are believed to aid in tissue repair and reduce inflammation by modulating the immune response. They are classified under regenerative medicine due to their ability to promote healing and tissue regeneration.

Investigated diseases

Crohn's disease – Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can lead to complications such as strictures, which are narrowings of the intestine that can cause blockages. Over time, the disease can cause damage to the intestinal walls, leading to further complications. The exact cause of Crohn's disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511034-12-00Protocol codeTJT2301Estimated enrolment50 patientsSponsorCentre Hospitalier Universitaire De Liege

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