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

NCT06488898 | Recruiting Phase 2

• 1 other identifier: HULP-STEM-EVAR-2020
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Efficacy evaluation of the study intervention.

  6 months

Other Outcomes (5)

• Stent migration in study intervention group vs historical cohort.

  12 months

• Presence of leaks on CT control in study intervention group vs historical cohort.

  12 months

• Reoperation at 1 year in study intervention group vs historical cohort.

  12 months

Study Arms (1)

Allogeneic adipose tissue-derived mesenchymal stem cells

EXPERIMENTAL

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

Interventions

Allogeneic adipose tissue-derived mesenchymal stem cells DRUG

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.

Allogeneic adipose tissue-derived mesenchymal stem cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT.
• Subjects with a good infrarenal neck for a standard device placement, neither fenestrated nor branched.
• The patient must be able to attend all study visits and comply with all study procedures.

You may not qualify if:

• Patients with unresolved neoplasia history or hematologic disease.
• Patients with severe heart failure (New York Heart Association \[NYHA\] IV) or ejection fraction \<20%.
• Patients with malignant ventricular arrhythmias
• Patients with deep vein thrombosis the last three months
• Patients with acute myocardial infarction or stroke in the previous month
• Infants or pregnant women
• Transplanted patients.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Grupo Dermatologico Y Estetico Pedro Jaen S.A.: collaborator

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: June 13, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-06

Locations

ES (1)