The aim of the study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with end-stage ischemic cardiomyopathy undergoing left ventricular assist device implantation.
End-stage ischemic cardiomyopathy (ICM) with non-graftable coronary arteries is a common and debilitating problem. The ultimate therapeutic goal in such cases is cardiac transplantation which is restricted by donor availability. Alternatively, left ventricular assist devices (LVAD) are increasingly used as bridge to transplantation or more recently as destination therapy in non-transplant candidates. Widely used second- and third-generation continuous-flow LVAD offer symptomatic relief and prolong life. However, LV unloading rarely improves native heart function in ischemic hearts. We aim to increase myocardial viability and improve native cardiac function in patients with end-stage ICM by injecting allogeneic bone marrow stem cells at the time of LVAD implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
AHEPA University Hospital
Thessaloniki, Greece
Improvement in myocardial perfusion/viability
Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis
Time frame: 12 months
Improvement in myocardial perfusion/viability
Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis
Time frame: 24 months
Morbidity
Major adverse cardiac and cerebrovascular events
Time frame: 12 months
Change in left ventricular function
Change in left ventricular function after combined mechanical and cellular therapy
Time frame: one year
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