Mesenchymal Stem Cells and Myocardial Ischemia

Mesenchymal stem cells from the bone marrow can differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue. The aim of the study is in a phase I safety study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.10 patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 24 months follow-up.

Inclusion criteria

• Age 18 to 75
• Male or female
• NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with)
• Chronic coronary artery disease with left ventricular function below 35%
• Stable medical therapy for at least one month
• Reversible perfusion defects by SPECT
• Not a candidate for coronary artery by-pass surgery due to poor targets or small vessels and not a candidate for percutaneous intervention due to small vessels or unreachable coronary lesions due to complicated anatomy
• Implantable Cardiovertor Defibrillator

Exclusion criteria

• Acute coronary syndrome, revascularization (PCI or CABG), or cardiac resynchronization during the last 3 months
• Sustained ventricular
• Further revascularization planned for the next 30 days.
• Chronic atrial fibrillation.
• A wall thickness in the target region <8 mm as determined by 2D echocardiography (the target region is defined at the time of NOGA® mapping).
• An LV thrombus.
• Severe peripheral vascular disease precluding femoral artery access as determined at time of original catheterization.
• Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to the LV.
• Human immunodeficiency virus (HIV1-2), HTLV-1 and 2.
• An active uncontrolled infection.
• A prosthetic aortic valve.
• A current or prior history within the last 3 years of neoplasm (excluding basal cell) and/or any active neoplasm within the last 24 months.
• Pregnancy or breastfeeding.
• Active participation in other research therapy for cardiovascular repair/regeneration.
• Any medical condition that would affect the investigator's ability to evaluate the subject's condition or could compromise the subject's safety.
• Any condition that, in the judgment of the investigator, would prohibit the subject from participating in the study.