A Phase 2 interventional study of Allogeneic adipose tissue-derived mesenchymal stem cells in Aortic Aneurysm, Abdominal, sponsored by Instituto de Investigación Hospital Universitario La Paz. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Instituto de Investigación Hospital Universitario La Paz · Phase 2, Interventional, and Other
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.
481 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's planned enrollment of 8 is below the median of 68 across 236 interventional studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 104 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Allogeneic adipose tissue-derived mesenchymal stem cells and expanded, which are considered an "advanced therapy medicinal product" according to European regulation (Regulation (EC) No 1394/2007).
Drug: Allogeneic adipose tissue-derived mesenchymal stem cells
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.
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.
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
Stent migration in study intervention group vs historical cohort.
Percentage of patients with stent migration compared to historical cohort.
Time frame: 12 months
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.
Time frame: 12 months
Reoperation at 1 year in study intervention group vs historical cohort.
Reoperation rate at 1 year compared to historical cohort.
Time frame: 12 months
Hospital admission in study intervention group vs historical cohort.
Hospital admission rate compared to historical cohort.
Time frame: 12 months
Quality of life in study intervention group.
Assessment of change in quality of life: specific quality of life assessment survey at one month and one year after treatment respect to baseline. A 10% change in quality of life scores is considered clinically relevant.
Time frame: 12 months
This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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