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

July 20, 2022 updated by: Kyriakos Anastasiadis, AHEPA University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 546 36
        • Ahepa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHEPA University Hospital

Investigators

  • Principal Investigator: Kyriakos Anastasiadis, MD, PhD, FETCS, Ahepa University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 27, 2012

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHEPA_CTL_02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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