Study on the Use of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treating Ulcerative Colitis in Patients

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What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	29.06.2023

Trial locations

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.

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.

Trial ID:

2024-518643-38-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Use of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treating Ulcerative Colitis in Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?