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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Cardiomyopathies
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014