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Study on the Safety of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells for Treating Inflammatory Bowel Strictures in Crohn’s Disease Patients

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What is this study about?

This clinical trial is focused on studying a treatment for Crohn’s disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The treatment being tested involves the use of allogeneic adipose tissue-derived mesenchymal stem cells, which are special cells taken from healthy donors’ fat tissue. These cells are expanded, meaning they are grown in larger numbers, and then injected into patients to help reduce inflammation and heal the affected areas in the intestines.

The purpose of this study is to evaluate how feasible and safe it is to administer these stem cells through a procedure called laparoscopic administration, which is a minimally invasive surgery. Patients with Crohn’s disease who have developed narrowings, or strictures, in their intestines due to inflammation are the focus of this research. The study will observe patients over a period of time to monitor any complications that may arise from the treatment and to see if there are improvements in the condition of the intestinal strictures.

Throughout the study, participants will undergo regular check-ups to assess changes in their symptoms and the condition of their intestines. This will include monitoring the length of the intestinal strictures and evaluating the overall impact on their quality of life. The study aims to provide valuable information on whether this stem cell treatment can be a safe and effective option for managing Crohn’s disease-related complications.

1 joining the trial

Upon joining the trial, written consent is required. Eligibility includes being between 18 and 75 years old, having Crohn’s disease diagnosed at least 6 months prior, and meeting specific medical criteria.

Women of childbearing age must have a negative pregnancy test and agree to use effective contraceptive measures during the study.

2 initial assessment

An initial assessment will be conducted to confirm the presence of a single inflammatory stenotic lesion in the small bowel or ileocolic area. This lesion should be the cause of intestinal blockage, as demonstrated by specific medical imaging.

3 treatment administration

The treatment involves the laparoscopic administration of allogeneic adipose tissue-derived mesenchymal stem cells (adMSCs). This is done through an injectable solution.

The procedure aims to evaluate the feasibility and safety of this treatment for inflammatory bowel strictures associated with Crohn’s disease.

4 monitoring and follow-up

Regular follow-up visits will be scheduled to monitor the patient’s condition and any potential complications from the treatment or anesthesia.

The change in the length of the stenosis and the patient’s condition will be evaluated at 6, 12, 18, 24, 36, and 52 weeks using specific questionnaires and medical imaging.

5 completion of the trial

The trial is expected to conclude by November 30, 2025. The final assessment will include evaluating the overall safety and effectiveness of the treatment.

Who Can Join the Study?

  • Patients who agree to participate and provide their written consent.
  • Patients aged over 18 years and under 75 years.
  • Patients with Crohn’s disease diagnosed at least 6 months earlier, confirmed by clinical tests, endoscopy (a procedure to look inside the digestive tract), tissue samples, and/or imaging tests.
  • Presence of a single inflammatory narrowing (stenotic lesion) in the small bowel or ileocolic area (part of the intestine), or where the small bowel connects to the colon, with a maximum length of 10 cm, shown by a special imaging test called enteroresonance. This narrowing should cause episodes of intestinal blockage or partial blockage. Other inflammatory areas are allowed, but only one should be the clear cause of the blockage.
  • Patients who have been treated with at least one biologic drug and did not respond well to regular doses before increasing the dose or changing/adding another drug. This includes:
    • Anti-TNF drugs (for at least 14 weeks, including starting and maintenance doses): Infliximab, Adalimumab, Certolizumab.
    • Anti-integrin drugs (for at least 14 weeks, including starting and maintenance doses): Vedolizumab.
    • Anti-IL-12/23 drugs (for at least 16 weeks, including starting and maintenance doses): Ustekinumab.
  • Women of childbearing age must have a negative pregnancy test at the start of the study and agree to use effective birth control methods while participating in the study.

Who Cannot Join the Study?

  • Patients who do not have Crohn’s disease cannot participate.
  • Patients with other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had a recent surgery related to their Crohn’s disease cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of severe allergic reactions cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Institut D Investigacio Sanitaria Pere Virgili Tarragona Spain
Hxhoezky Vcwu dywqldqs Barcelona Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
03.03.2023

Trial locations

Investigated drugs:

Allogeneic Mesenchymal Stem Cells (adMSC) are special cells that are taken from the fat tissue of healthy donors. These cells have the ability to transform into different types of cells and help repair damaged tissues. In this trial, the stem cells are administered through a minimally invasive surgery called laparoscopy. The goal is to see if these cells can safely and effectively treat narrowings in the intestines caused by Crohn’s disease, which is a condition that causes inflammation in the digestive tract.

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 active disease, known as flare-ups, and periods of remission. During flare-ups, individuals may experience symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can lead to complications like strictures, which are narrowings of the intestine that can cause blockages. Over time, the disease can cause damage to the intestinal walls, leading to the formation of fistulas or abscesses. The progression of Crohn’s disease varies among individuals, with some experiencing mild symptoms and others having more severe manifestations.

Trial ID:
2023-507108-30-00
Protocol code:
FJD-MEIC-21-01
NCT ID:
NCT05521672
Trial Phase:
Therapeutic exploratory (Phase II)

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