Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy

Phase 1

• Conditions: Heart Failure
• Interventions: Biological: Intramyocardial implantation of stem cells

• Registration Number: NCT01615250
• Lead Sponsor: Odessa National Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-06
• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-08
• Last Update Submitted: 2012-06-08
• Last Update Posted: 2012-06-11
• Primary Completion: 2015-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cells	Intramyocardial implantation of stem cells	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.

Primary Outcome Measures

Name	Time	Method
Change in global left ventricular ejection fraction and regional wall motion score index	6 and12 months	Change in global left ventricular ejection fraction and regional wall motion score index.

Secondary Outcome Measures

Name	Time	Method
Incidence of the major adverse cardiac events	6 and 12 months	Incidence of the major adverse cardiac events.

Trial Locations

Locations (1)

Odessa Regional Clinical Hospital; 🇺🇦 Odessa, Ukraine