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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2022-07-31

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.

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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.

Conditions

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Heart Failure Ischemic Cardiomyopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Allogeneic stem cells implantation

Intervention Type BIOLOGICAL

Interventions

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Allogeneic stem cells implantation

Intervention Type BIOLOGICAL

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