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

This study is currently recruiting participants. (see Contacts and Locations)
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

June 6, 2012
June 8, 2012
January 2012
January 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01615250 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2016
January 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact: Iurii I Karpenko, Dr, PhD +38048750113 ext +38048750113 arcard2@gmail.com
Ukraine
 
NCT01615250
ISCIC-2012
Not Provided
Iurii Kozlov, Odessa National Medical University
Odessa National Medical University
Not Provided
Principal Investigator: Iurii I Karpenko, Dr, PhD Odessa National Medical University
Odessa National Medical University
June 2012

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