Left Ventricular Assist Device Combined With Allogeneic Mesenchymal Stem Cells Implantation in Patients With End-stage Heart Failure.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of Intramyocardial Implantation of Allogeneic Mesenchymal Stem Cells in Patients With End-stage Heart Failure Undergoing Left Ventricular Assist Device Implantation

Conditions
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Heart Failure, Ischemic Cardiomyopathy

Intervention / Treatment
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* Biological: Allogeneic stem cells implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cells implantation<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in myocardial perfusion/viability | Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis | 12 months | 
| Improvement in myocardial perfusion/viability | Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Major adverse cardiac and cerebrovascular events | 12 months | 
| Change in left ventricular function | Change in left ventricular function after combined mechanical and cellular therapy | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cell implantation, coronary artery disease, left ventricular assist device