Left Ventricular Assist Device Combined With Allogeneic Mesenchymal Stem Cells Implantation in Patients With End-stage Heart Failure.
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.
Biological: Allogeneic stem cells implantation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Intramyocardial Implantation of Allogeneic Mesenchymal Stem Cells in Patients With End-stage Heart Failure Undergoing Left Ventricular Assist Device Implantation|
- Improvement in myocardial perfusion/viability [ Time Frame: one year ] [ Designated as safety issue: No ]Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis
- all-cause morbidity [ Time Frame: one year ] [ Designated as safety issue: No ]
- left ventricular function [ Time Frame: one year ] [ Designated as safety issue: No ]Change in left ventricular function after combined mechanical and cellular therapy
- all-cause mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Stem cells implantation
Patients with end-stage heart failure due to ischemic cardiomyopathy will undergo combined cellular and mechanical support with implantation of off-the-shelf allogeneic mesenchymal stem cells and left ventricular assist device.
|Biological: Allogeneic stem cells 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759212
|Contact: Polychronis Antonitsis, MD, DSc||+30 2310 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: Kyriakos Anastasiadis, MD, DSc, FETCS|
|Sub-Investigator: Polychronis Antonitsis, MD, DSc|
|Principal Investigator:||Kyriakos Anastasiadis, MD, DSc, FETCS||AHEPA University Hospital|