Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
Instituto de Investigación Hospital Universitario La Paz
8 participants
Jun 13, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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.
- 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.
- The patient must be able to attend all study visits and comply with all study procedures.
Exclusion Criteria12
- 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
- Patients with deep vein thrombosis the last three months
- Patient with active sepsis at the time of inclusion
- Patients with acute myocardial infarction or stroke in the previous month
- Any type of medical or psychiatric illness that, in investigator opinion, could be a reason for exclusion from the study.
- Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion in the study.
- Administration of any investigational drug at the time of inclusion or in the 3 months prior
- Infants or pregnant women
- Transplanted patients.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06488898