Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT01753440|
Recruitment Status : Unknown
Verified November 2013 by Kyriakos Anastasiadis, AHEPA University Hospital.
Recruitment status was: Recruiting
First Posted : December 20, 2012
Last Update Posted : November 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Ischemic Cardiomyopathy||Procedure: Intramyocardial implantation of allogeneic mesenchymal stem cells||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study on the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Implantation Combined With Bypass Grafting in Patients With Coronary Artery Disease and Ischemic Cardiomyopathy.|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2015|
Active Comparator: Stem cells implantation
Patients with severe coronary artery disease with ischemic cardiomyopathy managed with concomitant coronary artery bypass grafting and intramyocardial administration of allogeneic mensenchymal stem cells.
Procedure: Intramyocardial implantation of allogeneic mesenchymal stem cells
Intramyocardial implantation of allogeneic mesenchymal stem cells
- Left ventricular ejection fraction [ Time Frame: one year ]Change in left ventricular ejection fraction assesed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.
- Myocardial segmental perfusion [ Time Frame: one year ]change in segmental perfusion as assesed with SPECT after intramyocardial implantation of allogeneic mesenchymal stem cells.
- all-cause mortality [ Time Frame: one year ]
- all-cause morbidity [ Time Frame: one year ]
- major adverse cardiac and cerebrovascular events [ Time Frame: one year ]
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): NCT01753440
|Contact: Polychronis Antonitsis, MD, DSc||+ 30 firstname.lastname@example.org|
|AHEPA University Hospital||Recruiting|
|Thessaloniki, Greece, 546 36|
|Contact: Polychronis Antonitsis, MD, DSc + 30 2310 994871 email@example.com|
|Principal Investigator: Polychronis Antonitsis, MD, DSc|
|Principal Investigator:||Kyriakos Anastasiadis, MD, DSc, FETCS||AHEPA University Hospital|