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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
Investigational 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.
Hospital Universitario La Paz
Madrid, Spain
RECRUITINGSafety 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.
Time frame: 12 months
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.
Time frame: 6 months
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