Intracoronary Infusion of Bone Marrow Mononuclear Cells in Patients With Previous Myocardial Infarction.
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:
- Basal condition: defined as the immediately preceding to the administration of cell therapy treatment.
- Monitoring Condition 1: three months after drug administration of cell therapy. Includes non-invasive methods of exploration of ventricular function.
- Monitoring Condition 2: six months after administration of treatment. Includes the same methods of exploration of ventricular function practised in the basal condition, including cardiac catheterism as well as non invasive methods.
- Monitoring Condition 3: twelve months after administration of the cell therapy drug. Includes non-invasive methods of exploration of ventricular function.
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
Chronic Myocardial Ischemia
Other: Bone marrow mononuclear cells
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Trial on the Effect of Intracoronary Infusion of Bone Marrow Mononuclear Cells on Functional Recovery in Patients With Myocardial Chronic Back and Severely Depressed Left Ventricular Function.|
- Change from baseline in left ventricular ejection fraction (LVEF) [ Time Frame: 3, 6 and 12 months after intervention ] [ Designated as safety issue: No ]
- Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Functional grade of the New York Heart Association (NYHA) [ Time Frame: 3,6 and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Dose of bone marrow mononuclear cells: 5-7 x 108 total cells
Other: Bone marrow mononuclear cells
Intracoronary infusion of autologous bone marrow-derived mononuclear cells
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 24 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.
- To investigate the basic cellular mechanisms underlying the myocardial regeneration process through correlation between hemodynamic criteria for the ventricular function improvement and the biologicals corresponding to the composition and the functionality of the infused cells.
- To analyze clinical, hemodynamic and biologicals factors able to influence favorably to a greater degree of functional recovery after regenerative treatment in chronic myocardial infarction.
- To design, in view of the results obtained, suitable protocol for the application of cell therapy to treat patients with old anterior infarction, both in terms of the ideal characteristics of medullary graft as in terms of those patients more likely to be beneficiaries of it, in order to establish a definitive strategy of including cell therapy in the standard treatment of this disease in the near future provided that the results indicate it so.
The primary variable is the improvement in ventricular function monitoring under angiographic and echocardiographic parameters.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454323
|University Hospital Reina Sofía|
|Cordoba, Spain, 14004|
|Study Chair:||Jose Suarez de lezo, MD, PhD||University Hospital Reina Sofía, Córdoba.|
|Study Chair:||Inmaculada Herrera, MD, PhD||University Hospital Reina Sofía, Córdoba.|
|Principal Investigator:||Miguel Ángel Romero, MD||University Hospital Reina Sofía, Córdoba.|