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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto de Investigación Hospital Universitario La Paz

About this trial

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

Qualifiers

Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT.

Subjects ≥ 18 years at the time of inclusion.

Subjects with a good infrarenal neck for a standard device placement, neither fenestrated nor branched.

Patients with an estimated life expectancy greater than 2 years at the time of inclusion.

Disqualifiers

Patients with unresolved neoplasia history or hematologic disease.

Patients with uncontrolled arterial hypertension (≥180/110) at the time of inclusion.

Patients with severe heart failure (New York Heart Association [NYHA] IV) or ejection fraction <20%.

Patients with malignant ventricular arrhythmias

Trial design

Treatments tested in this trial

  • Allogeneic adipose tissue-derived mesenchymal stem cells

Treatment groups

8 Participants
are divided into 1 treatment group

Sponsors and collaborators

Instituto de Investigación Hospital Universitario La Paz

Lead sponsor

Grupo Dermatologico Y Estetico Pedro Jaen S.A.

Collaborator