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

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ClinicalTrials.gov Identifier: NCT01615250
Recruitment Status : Unknown
Verified June 2012 by Iurii Kozlov, Odessa National Medical University.
Recruitment status was:  Recruiting
First Posted : June 8, 2012
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Heart Failure Biological: Intramyocardial implantation of stem cells Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2012
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy Shock
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Change in global left ventricular ejection fraction and regional wall motion score index [ Time Frame: 6 and12 months ]
    Change in global left ventricular ejection fraction and regional wall motion score index.


Secondary Outcome Measures :
  1. Incidence of the major adverse cardiac events [ Time Frame: 6 and 12 months ]
    Incidence of the major adverse cardiac events.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012

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