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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Drug: Allogeneic adipose tissue-derived mesenchymal stem cells

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Luis Riera del Moral, Doctor of Medicine; Phone Number: 441189 917277000; Email: luis.riera@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT.
2. Subjects ≥ 18 years at the time of inclusion.
3. Subjects with a good infrarenal neck for a standard device placement, neither fenestrated nor branched.
4. Patients with an estimated life expectancy greater than 2 years at the time of inclusion.
5. 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.
6. The patient must be able to attend all study visits and comply with all study procedures.

Exclusion Criteria:

1. Patients with unresolved neoplasia history or hematologic disease.
2. Patients with uncontrolled arterial hypertension (≥180/110) at the time of inclusion.
3. Patients with severe heart failure (New York Heart Association [NYHA] IV) or ejection fraction <20%.
4. Patients with malignant ventricular arrhythmias
5. Patients with deep vein thrombosis the last three months
6. Patient with active sepsis at the time of inclusion
7. Patients with acute myocardial infarction or stroke in the previous month
8. Any type of medical or psychiatric illness that, in investigator opinion, could be a reason for exclusion from the study.
9. Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion in the study.
10. Administration of any investigational drug at the time of inclusion or in the 3 months prior
11. Infants or pregnant women
12. Transplanted patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Allogeneic adipose tissue-derived mesenchymal stem cells; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation of the study intervention:	The safety of the treatment will be evaluated using the following parameters: Proportion of procedure-related adverse events occurring throughout the study.; Proportion of adverse events related to allogeneic mesenchymal stem cells infusión derived from adipose tissue occurred throughout the study.; Proportion of patients with major adverse cerebral and cardiovascular events (MACCE) within 12 months after treatment.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent migration in study intervention group vs historical cohort.	Percentage of patients with stent migration compared to historical cohort.	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.	12 months
Reoperation at 1 year in study intervention group vs historical cohort.	Reoperation rate at 1 year compared to historical cohort.	12 months
Hospital admission in study intervention group vs historical cohort.	Hospital admission rate compared to historical cohort.	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.	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: HULP-STEM-EVAR-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No