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

Phase 2

Terminated

• Conditions: Ischemic Cardiomyopathy; Heart Failure
• Interventions: Biological: Allogeneic stem cells implantation

• Registration Number: NCT01759212
• Lead Sponsor: AHEPA University Hospital

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-27
• Study First Posted: 2013-01-03
• Status Verified: 2022-07
• Primary Completion: 2022-07
• Study Completion: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cells implantation	Allogeneic 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.

Primary Outcome Measures

Name	Time	Method
Improvement in myocardial perfusion/viability	24 months	Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis

Secondary Outcome Measures

Name	Time	Method
Change in left ventricular function	one year	Change in left ventricular function after combined mechanical and cellular therapy
Morbidity	12 months	Major adverse cardiac and cerebrovascular events

Trial Locations

Locations (1)

AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece