Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT01753440|
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Ischemic Cardiomyopathy||Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 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.|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2014|
Stem cells implantation
Patients with severe coronary artery disease and chronic ischemic cardiomyopathy with a LVEF ≤40% who are scheduled for elective CABG according to accepted guidelines. Additional criteria include the following: age <75 years, history of myocardial infarction (not less than 14 days before the procedure), LVEF ≤40 % assessed with echocardiography, and a distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization.
Procedure: Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).
Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP).
- iMP-related adverse events [ Time Frame: 12 months ]Major adverse cardiac and cerebrovascular events including death, postoperative myocardial infarction, need for revascularization, stroke, hospitalization for worsening heart failure, myocardial rupture, infectious myocarditis, or sustained ventricular arrhythmias.
- Hypersensitivity [ Time Frame: 12 months ]Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia)
- Scar reduction [ Time Frame: 4 months ]Myocardial scar size reduction assessed with SPECT
- Scar reduction [ Time Frame: 12 months ]Myocardial scar size reduction assess with SPECT
- LVEF [ Time Frame: 12 months ]Left ventricular ejection fraction
- Change in quality of life [ Time Frame: 12 months ]Quality of life evaluated with MLHFQ
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
|AHEPA University Hospital|
|Thessaloniki, Greece, 546 36|
|Principal Investigator:||Kyriakos Anastasiadis, MD, PhD FETCS||AHEPA University Hospital|