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

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

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01759212

Enrollment

Registered

2013-01-03

Start date

2012-10-31

Completion date

2022-07-31

Last updated

2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Ischemic Cardiomyopathy

Keywords

stem cell implantation, coronary artery disease, left ventricular assist device

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.

Interventions

BIOLOGICALAllogeneic stem cells implantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement in myocardial perfusion/viability	12 months	Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis

Secondary

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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026