Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy (ISCIC)
|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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Biological: Intramyocardial implantation of stem cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Incidence of the major adverse cardiac events [ Time Frame: 6 and 12 months ]Incidence of the major adverse cardiac events.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615250
|Contact: Iurii I Karpenko, Dr, PhD||+38048750113 ext +firstname.lastname@example.org|
|Odessa Regional Clinical Hospital||Recruiting|
|Odessa, Ukraine, 65025|
|Contact: Iurii I Karpenko, Dr, PhD +380487500115 ext +380487500115 email@example.com|
|Principal Investigator:||Iurii I Karpenko, Dr, PhD||Odessa National Medical University|