Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Safety evaluation of the study intervention:
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
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).
Intervention: Allogeneic adipose tissue-derived mesenchymal stem cells (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Efficacy evaluation of the study intervention.(6 months)