Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts
NCT ID: NCT06488898
Last Updated: 2024-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
8 participants
INTERVENTIONAL
2024-06-13
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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).
Allogeneic adipose tissue-derived mesenchymal stem cells
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.
Interventions
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Allogeneic adipose tissue-derived mesenchymal stem cells
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Grupo Dermatologico Y Estetico Pedro Jaen S.A.
UNKNOWN
Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Locations
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Hospital Universitario La Paz
Madrid, , Spain
Countries
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Facility Contacts
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Other Identifiers
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HULP-STEM-EVAR-2020
Identifier Type: -
Identifier Source: org_study_id
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