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.
Intramyocardial implantation of autologous peripheral mononuclear cells with CD34+ stem cells by NOGA.XP navigation system. Сell concentration is 200 million cells in 1 ml.
Treatment with standard therapy. Cardiospec shock-wave therapy
Group of of intramyocardial implantation of peripheral mononuclear cells with CD34+ stem cells in patient with ischemic cardiomyopathy 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