Safety and Efficacy of Intramyocardial Implantation of Allogeneic Mesenchymal Stem Cells in Patients With End-stage Heart Failure Undergoing Left Ventricular Assist Device Implantation
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- AHEPA University Hospital
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Improvement in myocardial perfusion/viability
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Kyriakos Anastasiadis
Professor Kyriakos Anastasiadis
AHEPA University Hospital
Eligibility Criteria
Inclusion Criteria
- •Age 18 to 75 years
- •End-stage heart failure due to ischemic cardiomyopathy that requires mechanical support according to current indications
- •Ability to provide informed consent
Exclusion Criteria
- •Not willing to provide informed consent
Outcomes
Primary Outcomes
Improvement in myocardial perfusion/viability
Time Frame: 24 months
Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis
Secondary Outcomes
- Change in left ventricular function(one year)
- Morbidity(12 months)