Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06488898

Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts

Led by Instituto de Investigación Hospital Universitario La Paz · Updated on 2024-07-08

8

Participants Needed

1

Research Sites

80 weeks

Total Duration

On this page

Sponsors

I

Instituto de Investigación Hospital Universitario La Paz

Lead Sponsor

G

Grupo Dermatologico Y Estetico Pedro Jaen S.A.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT.
  • Subjects 65 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 during their study participation.
  • The patient must be able to attend all study visits and comply with all study procedures.
Not Eligible

You will not qualify if you...

  • Patients with unresolved neoplasia history or hematologic disease.
  • Patients with uncontrolled arterial hypertension (65180/110) 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 in 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 could be a reason for exclusion from the study.
  • Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion.
  • Administration of any investigational drug at the time of inclusion or in the 3 months prior.
  • Infants or pregnant women.
  • Transplanted patients.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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