NCT06488898

Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aortic Aneurysm, Abdominal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-13
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-07-05
• Last updated: 2024-07-08

Locations

1 site across 1 country: Spain