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Study on the Use of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treating Ulcerative Colitis in 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 new treatment for ulcerative colitis, a condition that causes inflammation and sores in the colon. The treatment being tested involves the use of allogeneic adipose-derived mesenchymal stem cells, which are special cells taken from fat tissue and expanded in a lab. These cells are injected directly into the affected area of the colon to see if they can help reduce inflammation and improve symptoms.

The purpose of the study is to determine if this treatment can effectively decrease the inflammation in the colon and alleviate the symptoms associated with ulcerative colitis. Participants in the study will receive injections of these stem cells in varying doses, and some may receive a placebo for comparison. The study will monitor changes in inflammation and symptoms over a period of time, with assessments at several intervals after the treatment.

Throughout the study, researchers will also look for any potential side effects or complications related to the treatment. Additionally, they will examine whether the stem cells from different donors have varying abilities to modulate the immune system. The study aims to provide valuable insights into the potential of stem cell therapy as a local treatment for ulcerative colitis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria: age between 18 and 70 years, known ulcerative colitis limited to the left side of the colon, mild to moderate activity assessed by a complete Mayoscore greater than 2 and less than 10, ability to speak and understand Danish, and providing fully informed consent.
Step 2
Treatment administration
The treatment involves the injection of allogeneic adipose-derived mesenchymal stem cells directly into the mucosa. This is done using a suspension for injection in a pre-filled syringe.
Additionally, sodium chloride is used as a solution for injection or infusion.
Step 3
Monitoring and assessment
The primary goal is to observe a reduction in inflammatory activity, assessed with an endoscopic Mayoscore 14 days after treatment.
Secondary assessments occur at 4, 7, 14, and 30 days post-treatment, focusing on inflammatory activity, histological grading of inflammation, and symptom improvement.
Monitoring includes checking for complications or adverse events related to the treatment and evaluating the formation of HLA antibodies.
Step 4
Completion of study
The study is estimated to conclude by June 30, 2025. The final assessments will determine the effectiveness and safety of the treatment.

Who can join the trial?

5 criteria

Age between 18 and 70 years old
Has a known condition called ulcerative colitis, which affects only the left side of the large intestine
Has mild to moderate activity of ulcerative colitis, measured by a score called the Mayoscore, which should be more than 2 but less than 10
Can speak and understand Danish
Has given full informed consent, meaning they understand the study and agree to participate

Who cannot join the trial?

10 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to similar treatments are excluded.
Patients with other serious health conditions that might interfere with the study are not eligible.
Anyone who has participated in another clinical trial recently may be excluded.
Patients who are unable to follow the study procedures or attend follow-up visits cannot join.
Individuals with a history of drug or alcohol abuse may be excluded.
Patients who have had recent surgery related to their condition might not be eligible.
Anyone with an active infection that requires treatment is excluded.
Patients who are taking certain medications that could interfere with the study treatment may not participate.
Individuals with a history of certain types of cancer might be excluded.

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Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Adipose-derived mesenchymal stem cells are being studied as a treatment for ulcerative colitis. These are special cells taken from fat tissue that have the ability to develop into different types of cells. In this trial, they are injected directly into the lining of the intestine to see if they can help reduce inflammation and improve symptoms in patients with ulcerative colitis.

What is already known about the treatment

Adipose-derived mesenchymal stem cells – This treatment involves the local injection of stem cells derived from fat tissue directly into the mucosa of patients with ulcerative colitis. Currently, it is being studied in clinical trials to assess its effectiveness in reducing inflammation and symptoms associated with this condition. The main therapeutic indication is ulcerative colitis, a chronic inflammatory bowel disease. At the molecular level, these stem cells are believed to modulate the immune response and promote tissue repair by releasing various growth factors and cytokines. They are classified under regenerative medicine due to their potential to repair and regenerate damaged tissues.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to the formation of ulcers. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of exacerbation and remission. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in genetically predisposed individuals.