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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016599-66 | EudraCT Number |
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| Name | Class |
|---|---|
| Iniciativa Andaluza en Terapias Avanzadas | OTHER |
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Phase II clinical trial which will include all patients diagnosed with chronic anterior myocardial infarction (more than 6 months from the acute phase and the complete revascularization in which it is assessed the evolution of left ventricular function in patients to the monitoring against their own basal condition.
Included patients will be studied in the following conditions:
The trial hypothesis we propose consists of mononuclear cells of bone marrow providing progenitor cells with regenerative capacity and also secreting several angiogenic factors, and their implantation into ischemic tissues should contribute with both elements to the angiogenesis and tissue regeneration with myocardial functional recovery
This is an uncontrolled study in which the efficacy of the cell therapy drug is measured by comparing the variables of ventricular function after treatment to the basal condition prior to its application
The total number of patients to be studied 20. The study population will correspond to male and female patients with chronic anterior myocardial infarction (more than 6 months after the acute episode) and ventricular dysfunction. It is expected 36 months of inclusion and one year follow up
Patients will receive in a concomitant way the drug treatment established by the good practice, so it would certainly be possible that some improvement occurs due to drug treatment.
It will be studied the patient population of both genders aged between 18 and 80 years diagnosed with Chronic anterior myocardial infarction (more than 6 months after the acute phase and the complete revascularization).
Objectives of the study:
Main objective: To determine the efficacy of intracoronary injection of adult stem cells from autologous bone marrow in patients with chronic anterior myocardial infarction in terms of improvement of ventricular function, determined by hemodynamic, echocardiographic and New York Heart Association (NYHA) functional class criteria, resulting in an improvement of heart failure symptoms and quality of life's patient.
Secondary objectives:
The primary variable is the improvement in ventricular function monitoring under angiographic and echocardiographic parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Dose of bone marrow mononuclear cells: 5-7 x 108 total cells |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone marrow mononuclear cells | Other | Intracoronary infusion of autologous bone marrow-derived mononuclear cells |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in left ventricular ejection fraction (LVEF) | 3, 6 and 12 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events (MACE) | 12 months | |
| Functional grade of the New York Heart Association (NYHA) | 3,6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Suarez de lezo, MD, PhD | University Hospital Reina Sofía, Córdoba. | Study Chair |
| Inmaculada Herrera, MD, PhD | University Hospital Reina Sofía, Córdoba. | Study Chair |
| Miguel Ángel Romero, MD | University Hospital Reina Sofía, Córdoba. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Reina Sofía | Córdoba | Spain | 14004 | Spain |
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| Label | URL |
|---|---|
| Andalusian Molecular Biology and Regenerative Medicine Centre | View source |
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