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| Name | Class |
|---|---|
| Grupo Dermatologico Y Estetico Pedro Jaen S.A. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic adipose tissue-derived mesenchymal stem cells | Experimental | Allogeneic adipose tissue-derived mesenchymal stem cells and expanded, which are considered an "advanced therapy medicinal product" according to European regulation (Regulation (EC) No 1394/2007). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic adipose tissue-derived mesenchymal stem cells | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation of the study intervention: | The safety of the treatment will be evaluated using the following parameters:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy evaluation of the study intervention. | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stent migration in study intervention group vs historical cohort. | Percentage of patients with stent migration compared to historical cohort. | 12 months |
| Presence of leaks on CT control in study intervention group vs historical cohort. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
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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.
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|
Percentage of patients with presence of leaks on CT control at 1 month and a year compared to historical cohort.
| 12 months |
| Reoperation at 1 year in study intervention group vs historical cohort. | Reoperation rate at 1 year compared to historical cohort. | 12 months |
| Hospital admission in study intervention group vs historical cohort. | Hospital admission rate compared to historical cohort. | 12 months |
| Quality of life in study intervention group. | 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. | 12 months |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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