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
  Purpose

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.


Condition Intervention Phase
Heart Failure
Biological: Intramyocardial implantation of stem cells
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Odessa National Medical University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615250

Contacts
Contact: Iurii I Karpenko, Dr, PhD +38048750113 ext +38048750113 arcard2@gmail.com

Locations
Ukraine
Odessa Regional Clinical Hospital Recruiting
Odessa, Ukraine, 65025
Contact: Iurii I Karpenko, Dr, PhD    +380487500115 ext +380487500115    arcard2@gmail.com   
Sponsors and Collaborators
Odessa National Medical University
Investigators
Principal Investigator: Iurii I Karpenko, Dr, PhD Odessa National Medical University
  More Information

No publications provided

Responsible Party: Iurii Kozlov, Dr., PhD Iurii I Karpenko, Odessa National Medical University
ClinicalTrials.gov Identifier: NCT01615250     History of Changes
Other Study ID Numbers: ISCIC-2012
Study First Received: June 6, 2012
Last Updated: June 8, 2012
Health Authority: Ukraine: Coordination centre of transplantation of organs, tissues and cells

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014