ALLOGENEIC ADIPOSE-DERIVED MESENCHYMAL STEM CELLS EXPANDED for Abdominal aortic aneurysm

Inclusion criteria

• {"criterion_text":"- Subjects with AAA greater than 5 cm in diameter with indication for endovascular treatment, analyzed by aortic AngioCT."}
• {"criterion_text":"- Subjects ≥ 18 years of age at the time of inclusion."}
• {"criterion_text":"- Subjects with a good infrarenal neck for placement of a standard device, neither fenestrated nor branched."}
• {"criterion_text":"- Patients with an estimated life expectancy greater than two years at inclusion."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- The patient must be able to attend all study visits and abide by all study procedures."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Proportion of procedure-related adverse events occurring throughout the study.","definition_or_measurement_approach":"Measured as the proportion of procedure-related adverse events occurring throughout the study period."}
• {"endpoint_text":"- Proportion of adverse events related to allogeneic adipose tissue-derived mesenchymal stem cell infusion occurred throughout the study.","definition_or_measurement_approach":"Measured as the proportion of adverse events attributable to the allogeneic adipose-derived mesenchymal stem cell infusion occurring throughout the study period."}
• {"endpoint_text":"- Proportion of patients with major adverse cerebral and cardiovascular events (MACCE) within 12 months after treatment.","definition_or_measurement_approach":"Measured as the proportion of patients experiencing MACCE within 12 months after treatment."}

Secondary endpoints

• {"endpoint_text":"- Reduction of the size of the aneurysm sac in the imaging tests performed during follow-up (CT and Doppler echo). A reduction in the maximum diameter of the aneurysm sac greater than or equal to 5mm in a period of 6 months is considered significant.","definition_or_measurement_approach":"Reduction measured by CT and Doppler ultrasound; a decrease in maximum sac diameter ≥5 mm at 6 months is considered significant."}
• {"endpoint_text":"- Percentage of patients with stent migration compared to the historical cohort.","definition_or_measurement_approach":"Proportion of patients with stent migration assessed on imaging and compared to historical cohort rates."}
• {"endpoint_text":"- Percentage of patients with presence of leaks on control CT at 1 month and 1 year compared to the historical cohort.","definition_or_measurement_approach":"Proportion of patients with endoleaks identified on control CT at 1 month and 1 year, compared to a historical cohort."}
• {"endpoint_text":"- Reoperation rate at 1 year compared to historical cohort.","definition_or_measurement_approach":"Rate of reoperations within 1 year post-treatment compared with historical cohort."}
• {"endpoint_text":"- Hospital admission rate compared to the historical cohort.","definition_or_measurement_approach":"Hospital admission rate during follow-up compared to historical cohort."}
• {"endpoint_text":"- Assessment of change in quality of life: specific quality of life assessment survey at one month and one year after treatment with respect to baseline. A 10% change in quality of life scores is considered clinically relevant.","definition_or_measurement_approach":"Quality of life assessed by a specific survey at 1 month and 1 year versus baseline; ≥10% change in scores considered clinically relevant."}

Spain

Earliest CTIS Part Ii Submission Date

28-11-2023

Latest Decision Or Authorization Date

03-06-2024

Processing Time Days

188

Number Of Sites

1

Number Of Participants

8

Primary sponsor

Full Name

Grupo Dermatologico Y Estetico Pedro Jaen S.A.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain