Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753440
|Contact: Polychronis Antonitsis, MD, DSc||+ 30 email@example.com|
|AHEPA University Hospital||Recruiting|
|Thessaloniki, Greece, 546 36|
|Contact: Polychronis Antonitsis, MD, DSc + 30 2310 994871 firstname.lastname@example.org|
|Principal Investigator: Polychronis Antonitsis, MD, DSc|
|Principal Investigator:||Kyriakos Anastasiadis, MD, DSc, FETCS||AHEPA University Hospital|