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
|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.
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
|Contact: Iurii I Karpenko, Dr, PhD||+38048750113 ext +email@example.com|
|Odessa Regional Clinical Hospital||Recruiting|
|Odessa, Ukraine, 65025|
|Contact: Iurii I Karpenko, Dr, PhD +380487500115 ext +380487500115 firstname.lastname@example.org|
|Principal Investigator:||Iurii I Karpenko, Dr, PhD||Odessa National Medical University|