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

Last updated: July 4, 2024
Sponsor: Instituto de Investigación Hospital Universitario La Paz
Overall Status: Active - Recruiting

Phase

2

Condition

Aneurysm

Heart Disease

Cardiovascular Disease

Treatment

Allogeneic adipose tissue-derived mesenchymal stem cells

Clinical Study ID

NCT06488898
HULP-STEM-EVAR-2020
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, neitherfenestrated nor branched.

  4. Patients with an estimated life expectancy greater than 2 years at the time ofinclusion.

  5. Women with childbearing capacity must have a negative pregnancy test at the time ofinclusion and must agree to use highly effective contraceptive methods (diaphragmsplus spermicide or male condom plus spermicide, oral contraceptive combined with asecond method contraceptive implant, injectable contraceptive, permanentintrauterine device, sexual abstinence or partner with vasectomy) during their studyparticipation.

  6. The patient must be able to attend all study visits and comply with all studyprocedures.

Exclusion

Exclusion Criteria:

  1. Patients with unresolved neoplasia history or hematologic disease.

  2. Patients with uncontrolled arterial hypertension (≥180/110) at the time ofinclusion.

  3. Patients with severe heart failure (New York Heart Association [NYHA] IV) orejection 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 areason for exclusion from the study.

  9. Patient with major surgery or severe craniocerebral trauma in the 3 months prior toinclusion in the study.

  10. Administration of any investigational drug at the time of inclusion or in the 3months prior

  11. Infants or pregnant women

  12. Transplanted patients.

Study Design

Total Participants: 8
Treatment Group(s): 1
Primary Treatment: Allogeneic adipose tissue-derived mesenchymal stem cells
Phase: 2
Study Start date:
June 13, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

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