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

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What is this study about?

This clinical trial is focused on studying the treatment of an abdominal aortic aneurysm, a condition where a large blood vessel in the abdomen becomes enlarged and can potentially burst. The treatment being tested involves the use of allogeneic adipose-derived mesenchymal stem cells, which are special cells taken from donated fat tissue and expanded in a lab. These cells are then injected into the aneurysm area to see if they can help stabilize it.

The purpose of the study is to evaluate the safety and feasibility of using these stem cells in patients who are undergoing a procedure called endovascular surgical repair, which is a less invasive surgery to fix the aneurysm. Participants in the study will receive either the stem cell treatment or a placebo. The study will monitor participants for any side effects related to the procedure or the stem cells, as well as any major heart or brain-related events within a year after treatment.

Throughout the study, the size of the aneurysm will be checked using imaging tests like CT scans and Doppler echo. The study will also compare the results to past patients who did not receive the stem cell treatment. Other aspects being observed include the movement of the stent used in the repair, any leaks, the need for additional surgeries, hospital admissions, and changes in quality of life. The study is expected to continue until early 2026.

1 joining the study

Upon joining the study, eligibility is confirmed. This includes having an abdominal aortic aneurysm larger than 5 cm, being 18 years or older, and having a good infrarenal neck for device placement.

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

2 initial assessment

An initial assessment is conducted, including aortic AngioCT imaging to analyze the aneurysm.

The patient’s ability to attend all study visits and comply with procedures is confirmed.

3 treatment procedure

The treatment involves the implantation of allogeneic adipose-derived mesenchymal stem cells into the aneurysm sac.

This is done during the endovascular surgical repair of the aneurysm.

4 follow-up visits

Follow-up visits are scheduled to monitor the patient’s condition and the effects of the treatment.

Imaging tests such as CT and Doppler echo are performed to assess the size of the aneurysm sac.

5 monitoring adverse events

Throughout the study, any procedure-related adverse events are monitored.

The occurrence of major adverse cerebral and cardiovascular events is tracked for 12 months after treatment.

6 quality of life assessment

The patient’s quality of life is assessed at one month and one year after treatment.

A specific survey is used to measure changes in quality of life compared to baseline.

7 study completion

The study is estimated to end by February 2026.

Final assessments are conducted to evaluate the overall outcomes of the treatment.

Who Can Join the Study?

  • Patients with an abdominal aortic aneurysm that is larger than 5 cm and needs endovascular treatment. This is checked using a special scan called aortic AngioCT.
  • Patients who are 18 years old or older.
  • Patients with a suitable area below the kidneys for placing a standard device, which is not specially designed or branched.
  • Patients who are expected to live for more than two years.
  • Women who can have children must have a negative pregnancy test and agree to use very effective birth control methods during the study. These methods include using a diaphragm with spermicide, a male condom with spermicide, taking birth control pills with another method, using a contraceptive implant, getting contraceptive injections, having a permanent intrauterine device, practicing sexual abstinence, or having a partner who has had a vasectomy.
  • Patients must be able to attend all study visits and follow all study procedures.

Who Cannot Join the Study?

  • Patients who are not undergoing a procedure called endovascular surgical repair for an abdominal aortic aneurysm. This is a type of surgery to fix a bulge in the large blood vessel in the belly.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a group that is not included in the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name City Country Status
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.02.2024

Trial locations

Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells are being studied for their potential to stabilize abdominal aortic aneurysms. These stem cells are taken from the fat tissue of a donor and are used to see if they can help repair or strengthen the area around the aneurysm when implanted. The goal is to determine if this treatment is safe and can be effectively used alongside an endoprosthesis, which is a type of stent placed inside the artery to support it.

Investigated diseases:

Abdominal Aortic Aneurysm – An abdominal aortic aneurysm is a condition where the lower part of the aorta, the major blood vessel supplying blood to the body, becomes enlarged. This enlargement occurs due to a weakening of the aortic wall, which can lead to a bulge or ballooning effect. Over time, the aneurysm may grow larger and the risk of rupture increases, which can cause severe internal bleeding. The progression of the disease is often slow and may not present symptoms until the aneurysm is large or ruptures. Regular monitoring through imaging tests is crucial to assess the size and growth of the aneurysm.

Trial ID:
2022-501935-18-00
Protocol code:
HULP-STEM-EVAR-2020
Trial Phase:
Therapeutic exploratory (Phase II)

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