Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy (ISCIC)

This study is currently recruiting participants.

Verified June 2012 by Odessa National Medical University

Sponsor:

Information provided by (Responsible Party):

Iurii Kozlov, Odessa National Medical University

ClinicalTrials.gov Identifier:

NCT01615250

First received: June 6, 2012

Last updated: June 8, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 6, 2012

Last Updated Date

June 8, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in global left ventricular ejection fraction and regional wall motion score index [ Time Frame: 6 and12 months ] [ Designated as safety issue: No ]

Change in global left ventricular ejection fraction and regional wall motion score index.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01615250 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of the major adverse cardiac events [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Incidence of the major adverse cardiac events.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Biological: Intramyocardial implantation of stem cells

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.

Study Arm (s)

No Intervention: Standard therapy
Treatment with standard therapy. Cardiospec shock-wave therapy
Active Comparator: 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.

Intervention: Biological: Intramyocardial implantation of stem cells

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2016

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Iurii I Karpenko, Dr, PhD

+38048750113 ext +38048750113

arcard2@gmail.com

Location Countries ^ICMJE

Ukraine

Administrative Information

NCT Number ^ICMJE

NCT01615250

Other Study ID Numbers ^ICMJE

ISCIC-2012

Has Data Monitoring Committee

Not Provided

Responsible Party

Iurii Kozlov, Odessa National Medical University

Study Sponsor ^ICMJE

Odessa National Medical University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Iurii I Karpenko, Dr, PhD

Odessa National Medical University

Information Provided By

Odessa National Medical University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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