Abdominal Aortic Aneurysm Stabilization with mesenchymal stem Cells
- Conditions
- Patients with abdominal aortic aneurysm undergoing endovascular surgical repair.Therapeutic area: Not possible to specify
- Registration Number
- CTIS2022-501935-18-00
- Lead Sponsor
- Grupo Dermatologico Y Estetico Pedro Jaen S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 8
Subjects with AAA greater than 5 cm in diameter with indication for endovascular treatment, analyzed by aortic AngioCT., Subjects = 18 years of age at the time of inclusion., Subjects with a good infrarenal neck for placement of a standard device, neither fenestrated nor branched., Patients with an estimated life expectancy greater than two years at inclusion., Women of childbearing potential must have a negative pregnancy test at 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 participation in the study., The patient must be able to attend all study visits and abide by all study procedures.
Patients with a history of unresolved neoplasm or hematologic disease., Administration of any investigational drug at the time of inclusion or in the three months prior., Women who are breastfeeding or pregnant women., Transplanted patients., Patients with uncontrolled arterial hypertension (=180/110) at 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 in the last three months., Patient with active septic picture at the time of inclusion., Patients with acute myocardial infarction or stroke the previous month., Medical or psychiatric illness of any kind that, in the opinion of the investigator, may 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method