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
- Trial code
- 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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData 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