Study on Local Injection of Mesenchymal Stem Cells for Patients with Refractory Crohn’s Disease Lesions

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Crohn’s Disease, a chronic inflammatory condition that affects the digestive tract. The treatment being tested involves the use of mesenchymal stem cells, which are special cells derived from bone marrow. These cells are prepared in a laboratory and then injected directly into the affected areas of the body. The purpose of the study is to evaluate the safety and effectiveness of this treatment in healing difficult-to-treat lesions in patients with Crohn’s Disease.

Participants in the study will receive a local injection of the stem cells, known by the code name MSC, to target specific lesions that have not responded to conventional therapies. These therapies may include medications like azathioprine, 6-mercaptopurine, methotrexate, and biologic treatments such as anti-TNF therapies, vedolizumab, or ustekinumab. The study will monitor the healing of these lesions over a period of time, with assessments at 12 weeks and 48 weeks after the treatment. The study will also track any side effects or changes in the participants’ health throughout the trial.

Participants will be observed for improvements in their symptoms, including pain, general well-being, and the number of stools per day. The study will also evaluate changes in the Crohn’s Disease Activity Index (CDAI), which measures the severity of the disease, and the Short Health Scale (SHS), which assesses quality of life. Additionally, imaging techniques like MRI will be used to check for changes in the lesions. The trial aims to provide valuable information on whether this new cell-based therapy can offer a new option for patients with challenging cases of Crohn’s Disease.

1 initial treatment

Upon joining the clinical trial, you will receive a local injection of mesenchymal stem cells (MSC). These are special cells that are prepared outside the body and injected directly into the affected area.

The injection is a suspension for injection, meaning the cells are in a liquid form suitable for injection.

2 follow-up visit at 12 weeks

At 12 weeks after the initial treatment, a follow-up visit will be conducted to assess the healing of the lesion. This involves checking if the lesion has healed completely or partially.

Safety will also be evaluated by monitoring for any adverse events or changes in vital signs.

3 additional follow-up visits

Further follow-up visits will occur at weeks 24 and 48 to continue monitoring the healing process and safety.

During these visits, various assessments will be conducted, including the Patient Reported Outcomes (PRO), which involve your feedback on pain, general well-being, and the number of stools per day.

4 final assessment at 48 weeks

At the 48-week mark, a comprehensive assessment will be performed to evaluate the complete or partial healing of the lesion.

Additional evaluations will include the Crohn’s Disease Activity Index (CDAI), quality of life measures, and imaging tests like MRI to check for any changes in the condition of the intestines or colon.

Who Can Join the Study?

Patients must be 18 years of age or older.
Patients must sign the informed consent, which means they agree to participate in the study after understanding all the details.
Patients must have been diagnosed with Crohn’s Disease for more than 6 months.
Patients must have at least one lesion (damaged area) from Crohn’s Disease that has not improved with standard treatments. These treatments include certain medications like azathioprine, 6-mercaptopurine, methotrexate, and biologic treatments such as anti-TNF therapies, vedolizumab, or ustekinumab.
The refractory lesion (lesion not responding to treatment) must be one of the following:
- A stricture (narrowing) in the colon or ileum that is 2 to 5 cm long and can be seen during a colonoscopy. A colonoscopy is a procedure where a doctor uses a special camera to look inside the colon.
- An unhealed deep ulcer in the colon or ileum that can be seen during a colonoscopy.
- An actively draining perianal fistula, which is an abnormal connection near the anus that is leaking fluid.
The study will include 15 patients with strictures, 5 patients with unhealed deep ulcers, and 50 patients with actively draining perianal fistulas.

Who Cannot Join the Study?

Patients who do not have Crohn’s Disease cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

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Other Sites

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

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	06.11.2017

Trial locations

Mesenchymal Stem Cells are a type of cell therapy used in this clinical trial. These cells are special because they can develop into different types of cells in the body. In this study, they are injected directly into the areas affected by Crohn’s disease, which is a condition that causes inflammation in the digestive tract. The goal of using these stem cells is to help heal the damaged tissues and reduce inflammation, which may improve symptoms and promote healing of the lesions that are difficult to treat with other therapies.

Investigated diseases:

Crohn's disease

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 inflammation can cause symptoms like abdominal pain, diarrhea, and weight loss. Over time, the inflammation can lead to complications such as strictures, fistulas, and abscesses. The disease can affect any part of the digestive tract from the mouth to the anus, but it most commonly impacts the end of the small intestine and the beginning of the colon. The inflammation in Crohn’s Disease can penetrate deep into the layers of the bowel tissue, leading to significant discomfort and complications. The progression of the disease varies among individuals, with some experiencing mild symptoms and others facing severe complications.

Trial ID:

2024-514033-37-00

Protocol code:

TJT1707P1MSC

NCT ID:

NCT03901235

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Local Injection of Mesenchymal Stem Cells for Patients with Refractory Crohn’s Disease Lesions

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