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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

4 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells – This medication is administered through implantation directly into the sac of an abdominal aortic aneurysm during endovascular surgical repair. It is currently being evaluated in clinical trials to assess its safety and feasibility for this specific use. The main therapeutic indication is for patients undergoing repair of an abdominal aortic aneurysm. At the molecular level, these stem cells are believed to aid in tissue repair and stabilization by differentiating into various cell types and releasing factors that promote healing. They are classified pharmacologically as a type of regenerative medicine therapy.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501935-18-00Protocol codeHULP-STEM-EVAR-2020Estimated enrolment8 patientsSponsorGrupo Dermatologico Y Estetico Pedro Jaen S.A.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).