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

1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
06.06.2023

Trial locations

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.

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 ID:
2024-511034-12-00
Protocol code:
TJT2301
NCT ID:
NCT06317818
Trial Phase:
Therapeutic exploratory (Phase II)

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