Status:
RECRUITING
Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsors:
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Conditions:
Aortic Aneurysm, Abdominal
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06488898
Start Date
June 13 2024
End Date
December 31 2025
Last Update
July 8 2024
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Spain, 28046