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.
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.
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
Single group
Allogeneic adipose tissue-derived mesenchymal stem cells
DrugInvestigational medicinal product: Allogeneic adipose tissue-derived mesenchymal stem cells and expanded, which are considered an "advanced therapy medicinal product" under European regulation (Article 2(1) of Regulation (EC) No 1394/2007 of the European Parliament and the Council of November 13 th 2007 about advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004). Administration form: Local injection by means of a catheter placed inside the previously excluded aneurysmal sac. Administration dose: 1x10000000 cells/kg patient weight. Administration guidelines: single infusion on the endovascular day AAA intervention.
Safety evaluation of the study intervention:
The safety of the treatment will be evaluated using the following parameters: 1. Proportion of procedure-related adverse events occurring throughout the study. 2. Proportion of adverse events related to allogeneic mesenchymal stem cells infusión derived from adipose tissue occurred throughout the study. 3. Proportion of patients with major adverse cerebral and cardiovascular events (MACCE) within 12 months after treatment.
Efficacy evaluation of the study intervention.
Change in size of the aneurysm sac by using imaging tests performed during follow-up (CT and echo Doppler). A reduction of the aneurysm sac maximum diameter greater than or equal to 5mm in a period of 6 months is considered significant.
Stent migration in study intervention group vs historical cohort.
Percentage of patients with stent migration compared to historical cohort.
Presence of leaks on CT control in study intervention group vs historical cohort.
Percentage of patients with presence of leaks on CT control at 1 month and a year compared to historical cohort.
Reoperation at 1 year in study intervention group vs historical cohort.
Reoperation rate at 1 year compared to historical cohort.
Hospital admission in study intervention group vs historical cohort.
Hospital admission rate compared to historical cohort.
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Instituto de Investigación Hospital Universitario La Paz
Lead sponsor
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Collaborator
