About this trial
Phase IIa, single-center clinical trial compared with historical cohorts to evaluate the preliminary safety and efficacy of an allogeneic adipose tissue-derived mesenchymal stem cells infusion in an aneurysmal sac for the treatment of AAA.
Eligibility criteria
Qualifiers
Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT.
Subjects ≥ 18 years at the time of inclusion.
Subjects with a good infrarenal neck for a standard device placement, neither fenestrated nor branched.
Patients with an estimated life expectancy greater than 2 years at the time of inclusion.
Disqualifiers
Patients with unresolved neoplasia history or hematologic disease.
Patients with uncontrolled arterial hypertension (≥180/110) at the time of inclusion.
Patients with severe heart failure (New York Heart Association [NYHA] IV) or ejection fraction <20%.
Patients with malignant ventricular arrhythmias
Trial design
Treatments tested in this trial
- Allogeneic adipose tissue-derived mesenchymal stem cells
Treatment groups
Sponsors and collaborators
Instituto de Investigación Hospital Universitario La Paz
Lead sponsor
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Collaborator