Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
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.
• 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.
• The patient must be able to attend all study visits and comply with all study procedures.