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

July 4, 2024 updated by: Instituto de Investigación Hospital Universitario La Paz
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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:
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy evaluation of the study intervention.
Time Frame: 6 months
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.
Time Frame: 12 months
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.
Time Frame: 12 months
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.
Time Frame: 12 months
Reoperation rate at 1 year compared to historical cohort.
12 months
Hospital admission in study intervention group vs historical cohort.
Time Frame: 12 months
Hospital admission rate compared to historical cohort.
12 months
Quality of life in study intervention group.
Time Frame: 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborators

Grupo Dermatologico Y Estetico Pedro Jaen S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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