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

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ClinicalTrials.gov Identifier: NCT01759212
Recruitment Status : Active, not recruiting
First Posted : January 3, 2013
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Kyriakos Anastasiadis, 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.

Condition or disease Intervention/treatment Phase
Heart Failure Ischemic Cardiomyopathy Biological: Allogeneic stem cells implantation Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Intramyocardial Implantation of Allogeneic Mesenchymal Stem Cells in Patients With End-stage Heart Failure Undergoing Left Ventricular Assist Device Implantation
Study Start Date : October 2012
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Improvement in myocardial perfusion/viability [ Time Frame: 12 months ]
    Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis

  2. Improvement in myocardial perfusion/viability [ Time Frame: 24 months ]
    Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 12 months ]
    Major adverse cardiac and cerebrovascular events

  2. Change in left ventricular function [ Time Frame: one year ]
    Change in left ventricular function after combined mechanical and cellular therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759212


Locations
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Greece
AHEPA University Hospital
Thessaloniki, Greece, 546 36
Sponsors and Collaborators
AHEPA University Hospital
Investigators
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Principal Investigator: Kyriakos Anastasiadis, MD, PhD, FETCS AHEPA University Hospital
Publications:
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Responsible Party: Kyriakos Anastasiadis, Professor Kyriakos Anastasiadis, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT01759212    
Other Study ID Numbers: AHEPA_CTL_02
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Keywords provided by Kyriakos Anastasiadis, AHEPA University Hospital:
stem cell implantation
coronary artery disease
left ventricular assist device
Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases