Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy

Phase I Study to Evaluate the Efficacy and Safety of Intramyocardial Implantation of Peripheral Mononuclear Cells With CD34+ Stem Cells in Patient With Ischemic Cardiomyopathy After Preparatory Course of Shock - Wave Therapy

This is a randomized study of efficiency and safety of intramyocardial implantation of peripheral mononuclear cells with high concentration of CD34+ stem cells in patients with myocardial ischemia after preparatory course of shock - wave therapy.

Inclusion Criteria:

• Patients with ischemic cardiomyopaty and HF II-IV NYHA class
• MI more than 6 months before the study
• LVEF less than 35%
• Absence effect of coronary revascularization during 6 months
• Optimal pharmacological therapy no less than 8 weeks
• Heart transplantation is contraindicated
• Patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)
• Patients giving informed consent

Exclusion Criteria:

• Acute coronary syndrome
• Coronary revascularization less than 6 months
• Patients requiring surgical correction of post-MI aneurism
• LV wall thickness less than 5 mm in site of possible injection
• Patients with CRT implanted within 3 month before cells injection
• Clinically significant associated diseases
• Active oncology desiase
• Pregnancy