Using stem cells to treat abdominal aortic aneurysms

Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts

This study is testing if using stem cells from fat tissue can help people with large abdominal aortic aneurysms feel better and prevent complications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Instituto de Investigación Hospital Universitario La Paz (Academic / other)
• Locations: 1 site (Madrid)
• Trial ID: NCT06488898 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the safety and efficacy of infusing allogeneic adipose tissue-derived mesenchymal stem cells into the aneurysmal sac of patients with abdominal aortic aneurysms (AAA) greater than 5 cm in diameter. The trial is conducted at a single center and compares outcomes with historical cohorts to assess the potential benefits of this innovative treatment approach. Participants must meet specific eligibility criteria, including having a suitable anatomical configuration for standard endovascular treatment. The study aims to provide preliminary data on the effectiveness of stem cell therapy in stabilizing AAA.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with abdominal aortic aneurysms greater than 5 cm in diameter who are eligible for endovascular treatment.

Not a fit: Patients with unresolved neoplasia history or hematologic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a novel therapeutic option for patients with abdominal aortic aneurysms, potentially reducing the need for surgical interventions.

How similar studies have performed: While the use of stem cells in vascular conditions is an emerging field, this specific approach has not been widely tested, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

1. Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT.
2. Subjects ≥ 18 years at the time of inclusion.
3. Subjects with a good infrarenal neck for a standard device placement, neither fenestrated nor branched.
4. Patients with an estimated life expectancy greater than 2 years at the time of inclusion.
5. Women with childbearing capacity must have a negative pregnancy test at the time of inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or partner with vasectomy) during their study participation.
6. The patient must be able to attend all study visits and comply with all study procedures.

Exclusion Criteria:

1. Patients with unresolved neoplasia history or hematologic disease.
2. Patients with uncontrolled arterial hypertension (≥180/110) at the time of inclusion.
3. Patients with severe heart failure (New York Heart Association \[NYHA\] IV) or ejection fraction \<20%.
4. Patients with malignant ventricular arrhythmias
5. Patients with deep vein thrombosis the last three months
6. Patient with active sepsis at the time of inclusion
7. Patients with acute myocardial infarction or stroke in the previous month
8. Any type of medical or psychiatric illness that, in investigator opinion, could be a reason for exclusion from the study.
9. Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion in the study.
10. Administration of any investigational drug at the time of inclusion or in the 3 months prior
11. Infants or pregnant women
12. Transplanted patients.

Where this trial is running

Madrid

• Hospital Universitario La Paz — Madrid, Spain (Recruiting)

Conditions Aortic Aneurysm, Abdominal