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Taking peoplePhase 2

"Abdominal Aortic Aneurysm Stabilization with mesenchymal stem Cells"

Key facts

Who runs it
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Where
Spain1 site in 1 countryChoose a country to see its sites
Status
Recruiting
Phase
Phase 2
People taking part
8 people, planned
Started
12 Jun 2024
Planned end
1 Feb 2026
Type of study
Interventional
Record updated
3 June 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Subjects with AAA greater than 5 cm in diameter with indication for endovascular treatment, analyzed by aortic AngioCT
  • Subjects ≥ 18 years of age at the time of inclusion
  • Subjects with a good infrarenal neck for placement of a standard device, neither fenestrated nor branched
  • Patients with an estimated life expectancy greater than two years at inclusion
  • Women of childbearing potential must have a negative pregnancy test at 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 participation in the study
  • The patient must be able to attend all study visits and abide by all study procedures

Who cannot take part

  • Administration of any investigational drug at the time of inclusion or in the three months prior
  • Patients with acute myocardial infarction or stroke the previous month
  • Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion in the study
  • Patients with a history of unresolved neoplasm or hematologic disease
  • Patients with uncontrolled arterial hypertension (≥180/110) at inclusion
  • Patients with malignant ventricular arrhythmias
  • Patients with deep vein thrombosis in the last three months
  • Medical or psychiatric illness of any kind that, in the opinion of the investigator, may be a reason for exclusion from the study
  • Patients with severe heart failure (New York Heart Association [NYHA] IV) or ejection fraction <20%
  • Women who are breastfeeding or pregnant women
  • Transplanted patients
  • Patient with active septic picture at the time of inclusion

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

To evaluate the safety and feasibility of an allogeneic adipose tissue-derived mesenchymal stem cell implantation in the sac of an abdominal aortic aneurysm treated by endoprosthesis.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
"Abdominal Aortic Aneurysm Stabilization with Truncal Cells: Controlled Clinical Trial with Historical Cohorts."
Record updated
3 June 2024