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"Abdominal Aortic Aneurysm Stabilization with mesenchymal stem Cells"
EU CTIS ID: 2022-501935-18-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Patients with a history of unresolved neoplasm or hematologic disease.
- Administration of any investigational drug at the time of inclusion or in the three months prior.
- Women who are breastfeeding or pregnant women.
- Transplanted patients.
- Patients with uncontrolled arterial hypertension (≥180/110) at inclusion.
- Patients with severe heart failure (New York Heart Association [NYHA] IV) or ejection fraction <20%.
See the full eligibility criteria
- 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.
- Patients with a history of unresolved neoplasm or hematologic disease.
- Administration of any investigational drug at the time of inclusion or in the three months prior.
- Women who are breastfeeding or pregnant women.
- Transplanted patients.
- Patients with uncontrolled arterial hypertension (≥180/110) at 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 septic picture at the time of inclusion.
- Patients with acute myocardial infarction or stroke the previous month.
- Medical or psychiatric illness of any kind that, in the opinion of the investigator, may be a reason for exclusion from the study.
- Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion in the study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.