Aortic Aneurysm, Abdominal
Conditions
Brief summary
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.
Interventions
Investigational medicinal product: Allogeneic adipose tissue-derived mesenchymal stem cells and expanded, which are considered an advanced therapy medicinal product under European regulation (Article 2(1) of Regulation (EC) No 1394/2007 of the European Parliament and the Council of November 13 th 2007 about advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004). Administration form: Local injection by means of a catheter placed inside the previously excluded aneurysmal sac. Administration dose: 1x10000000 cells/kg patient weight. Administration guidelines: single infusion on the endovascular day AAA intervention.
Sponsors
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects with AAA greater than 5 cm diameter with endovascular treatment indication, analyzed by aortic AngioCT. 2. Subjects ≥ 18 years at the time of inclusion. 3. Subjects with a good infrarenal neck for a standard device placement, neither fenestrated nor branched. 4. Patients with an estimated life expectancy greater than 2 years at the time of inclusion. 5. Women with childbearing capacity must have a negative pregnancy test at the time of 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 study participation. 6. The patient must be able to attend all study visits and comply with all study procedures.
Exclusion criteria
1. Patients with unresolved neoplasia history or hematologic disease. 2. Patients with uncontrolled arterial hypertension (≥180/110) at the time of inclusion. 3. Patients with severe heart failure (New York Heart Association \[NYHA\] IV) or ejection fraction \<20%. 4. Patients with malignant ventricular arrhythmias 5. Patients with deep vein thrombosis the last three months 6. Patient with active sepsis at the time of inclusion 7. Patients with acute myocardial infarction or stroke in the previous month 8. Any type of medical or psychiatric illness that, in investigator opinion, could be a reason for exclusion from the study. 9. Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion in the study. 10. Administration of any investigational drug at the time of inclusion or in the 3 months prior 11. Infants or pregnant women 12. Transplanted patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation of the study intervention: | 12 months | The safety of the treatment will be evaluated using the following parameters: 1. Proportion of procedure-related adverse events occurring throughout the study. 2. Proportion of adverse events related to allogeneic mesenchymal stem cells infusión derived from adipose tissue occurred throughout the study. 3. Proportion of patients with major adverse cerebral and cardiovascular events (MACCE) within 12 months after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy evaluation of the study intervention. | 6 months | Change in size of the aneurysm sac by using imaging tests performed during follow-up (CT and echo Doppler). A reduction of the aneurysm sac maximum diameter greater than or equal to 5mm in a period of 6 months is considered significant. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reoperation at 1 year in study intervention group vs historical cohort. | 12 months | Reoperation rate at 1 year compared to historical cohort. |
| Stent migration in study intervention group vs historical cohort. | 12 months | Percentage of patients with stent migration compared to historical cohort. |
| Quality of life in study intervention group. | 12 months | Assessment of change in quality of life: specific quality of life assessment survey at one month and one year after treatment respect to baseline. A 10% change in quality of life scores is considered clinically relevant. |
| Hospital admission in study intervention group vs historical cohort. | 12 months | Hospital admission rate compared to historical cohort. |
| Presence of leaks on CT control in study intervention group vs historical cohort. | 12 months | Percentage of patients with presence of leaks on CT control at 1 month and a year compared to historical cohort. |
Countries
Spain
Outcome results
None listed