Clinical trial NCT06488898: Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
Official title: Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Aortic Aneurysm, Abdominal
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Grupo Dermatologico Y Estetico Pedro Jaen S.A.
First posted: 2024-07-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT.
2. Subjects ≥ 18 years at the time of inclusion.
3. Subjects with a good infrarenal neck for a standard device placement, neither fenestrated nor branched.
4. Patients with an estimated life expectancy greater than 2 years at the time of inclusion.
5. 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.
6. The patient must be able to attend all study visits and comply with all study procedures.

Exclusion Criteria:

1. Patients with unresolved neoplasia history or hematologic disease.
2. Patients with uncontrolled arterial hypertension (≥180/110) at the time of inclusion.
3. Patients with severe heart failure (New York Heart Association \[NYHA\] IV) or ejection fraction \<20%.
4. Patients with malignant ventricular arrhythmias
5. Patients with deep vein thrombosis the last three months
6. Patient with active sepsis at the time of inclusion
7. Patients with acute myocardial infarction or stroke in the previous month
8. Any type of medical or psychiatric illness that, in investigator opinion, could be a reason for exclusion from the study.
9. Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion in the study.
10. Administration of any investigational drug at the time of inclusion or in the 3 months prior
11. Infants or pregnant women
12. Transplanted patients.

Primary outcomes:
measure: Safety evaluation of the study intervention:
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy evaluation of the study intervention.
timeFrame: 6 months
Other outcomes:
measure: Stent migration in study intervention group vs historical cohort.
timeFrame: 12 months
measure: Presence of leaks on CT control in study intervention group vs historical cohort.
timeFrame: 12 months
measure: Reoperation at 1 year in study intervention group vs historical cohort.
timeFrame: 12 months
measure: Hospital admission in study intervention group vs historical cohort.
timeFrame: 12 months
measure: Quality of life in study intervention group.
timeFrame: 12 months
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: