Trial | NCT01615250  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    stem cells ...

  • Study Participants

    50
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.
Study Started
Jan 31
2012
Primary Completion
Jan 31
2015
Anticipated
Study Completion
Jan 31
2016
Anticipated
Last Update
Jun 11
2012
Estimate

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.

Standard therapy No Intervention

Treatment with standard therapy. Cardiospec shock-wave therapy

Stem cells Active Comparator

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.

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
No Results Posted