Aortic aneurysm Trials in Disease

Study on Abdominal Aortic Aneurysm Treatment with Allogeneic Adipose-Derived Mesenchymal Stem Cells for Patients Undergoing Endovascular Repair

This trial is being conducted in Spain and focuses on a new approach to treating abdominal aortic aneurysms using stem cell therapy alongside standard surgical repair.

Who can join: This study is looking for patients who have an abdominal aortic aneurysm larger than 5 cm that requires endovascular treatment. Participants must be at least 18 years old and have a life expectancy of more than two years. The aneurysm must be located in a suitable area below the kidneys for placing a standard device. Women of childbearing age must have a negative pregnancy test and agree to use effective birth control throughout the study. All participants need to be able to attend regular study visits and follow the required procedures.

Who cannot join: Patients who are not undergoing endovascular surgical repair for their abdominal aortic aneurysm cannot participate. Those outside the specified age range or who belong to vulnerable populations requiring special protection are also excluded from the study.

What the trial studies: This research evaluates whether allogeneic adipose-derived mesenchymal stem cells can help stabilize abdominal aortic aneurysms. These are special cells taken from donated fat tissue and expanded in a laboratory. During the endovascular repair procedure, these stem cells are injected into the aneurysm area to see if they can help strengthen and stabilize it. The study will monitor participants for safety, tracking any procedure-related side effects and major heart or brain events for 12 months after treatment. Researchers will use CT scans and Doppler echo imaging to check the size of the aneurysm throughout the study. They will also assess quality of life, need for additional surgeries, and hospital admissions. The trial is expected to continue until early 2026.

Investigational treatment: The stem cells being tested are allogeneic adipose tissue-derived mesenchymal stem cells, which are taken from donor fat tissue and used to see if they can help repair or strengthen the area around the aneurysm when implanted alongside the endoprosthesis, a type of stent placed inside the artery for support.

Study on Metformin Embonate to Slow Growth of Small Abdominal Aortic Aneurysms in Patients Without Diabetes

This trial is taking place in Sweden, the Netherlands, and Denmark, and explores whether an existing diabetes medication can help slow the growth of small abdominal aortic aneurysms.

Who can join: This study is recruiting participants between 50 and 80 years old who have a documented small abdominal aortic aneurysm under active surveillance. For men, the aneurysm should measure 30-49 mm, and for women, 30-44 mm. Importantly, participants must have no history of diabetes, and their fasting blood sugar level should be below 7.0 mmol/L. All participants must provide written informed consent after understanding the study details.

Who cannot join: Patients with a history of diabetes cannot participate in this trial. Those whose aneurysm is not within the specified size range or who are not under active surveillance for a small abdominal aortic aneurysm are excluded. Patients outside the 50-80 age range and those belonging to vulnerable populations are also not eligible.

What the trial studies: This research investigates whether taking 2 grams of metformin daily for five years can slow down the growth rate of small abdominal aortic aneurysms in patients without diabetes. Metformin is a medication commonly used to manage blood sugar in people with type 2 diabetes, but this study explores its potential benefits for aneurysm management. Participants will be monitored over the five-year period with assessments at the start, after 24 months, and at the end of the study. The researchers will measure changes in aneurysm size using CT imaging, examine quality of life improvements, and assess whether the treatment reduces the need for surgery. An interim analysis at 24 months will evaluate safety and effectiveness. The study will also explore the relationship between metformin dosage or treatment duration and its effects on inflammation and tissue changes around the blood vessel.

Investigational treatment: Metformin, administered orally in tablet form, is being tested for its ability to reduce the yearly growth rate of small abdominal aortic aneurysms. The medication works by activating an enzyme called AMP-activated protein kinase, which may influence vascular health and help slow aneurysm progression.

Summary

The two ongoing clinical trials for aortic aneurysm represent distinct therapeutic approaches. One trial in Spain focuses on regenerative medicine using stem cell therapy for patients undergoing surgical repair of larger aneurysms. The other, conducted across three countries in Northern Europe, takes a preventive approach by repurposing metformin to slow the growth of smaller aneurysms before they require surgical intervention.

The geographical distribution shows a concentration of research activity in Northern Europe, with the metformin study spanning Sweden, Netherlands, and Denmark, while Spain leads in exploring innovative stem cell therapies. Both studies reflect the medical community's efforts to find new ways to manage this condition, whether through stabilization during repair or prevention of growth in earlier stages.

Patients interested in participating should carefully review the eligibility criteria, as one trial targets those already requiring surgery while the other focuses on smaller aneurysms under surveillance. The diabetes status requirement in the metformin trial is particularly important to note.