Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Biological: Intramyocardial implantation of stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard therapy<br>Treatment with standard therapy. Cardiospec shock-wave therapy | |
| Active Comparator: Stem cells<br>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. | Biological: Intramyocardial implantation of stem cells<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global left ventricular ejection fraction and regional wall motion score index | Change in global left ventricular ejection fraction and regional wall motion score index. | 6 and12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the major adverse cardiac events | Incidence of the major adverse cardiac events. | 6 and 12 months |