Intracoronary Infusion of Bone Marrow Mononuclear Cells in Patients With Previous Myocardial Infarction.
Condition: Chronic Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      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
    

Detailed description: 
      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:

             1. 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.

             2. 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.

             3. 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.
    

Intervention name(s): Bone marrow mononuclear cells
Intervention type(s): Other
Intervention description(s): Intracoronary infusion of autologous bone marrow-derived mononuclear cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Myocardial Ischemia; Cell therapy; Bone marrow mononuclear cells