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

Odessa National Medical University1 site in 1 country50 target enrollmentJanuary 2012

ConditionsHeart Failure

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Odessa National Medical University
Enrollment: 50
Locations: 1
Primary Endpoint: Change in global left ventricular ejection fraction and regional wall motion score index
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

January 2016

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Odessa National Medical University

Responsible Party

Principal Investigator

Iurii Kozlov

Dr., PhD Iurii I Karpenko

Odessa National Medical University

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