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

Primary Purpose

Heart Failure, Ischemic Cardiomyopathy

Status
Terminated
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Allogeneic stem cells implantation
Sponsored by
AHEPA University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring stem cell implantation, coronary artery disease, left ventricular assist device

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AHEPA University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem cells implantation

Arm Description

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.

Outcomes

Primary Outcome Measures

Improvement in myocardial perfusion/viability
Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis
Improvement in myocardial perfusion/viability
Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis

Secondary Outcome Measures

Morbidity
Major adverse cardiac and cerebrovascular events
Change in left ventricular function
Change in left ventricular function after combined mechanical and cellular therapy

Full Information

First Posted
December 18, 2012
Last Updated
July 20, 2022
Sponsor
AHEPA University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01759212
Brief Title
Left Ventricular Assist Device Combined With Allogeneic Mesenchymal Stem Cells Implantation in Patients With End-stage Heart Failure.
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 Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of eligible patients
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2022 (Actual)
Study Completion Date
July 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AHEPA University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ischemic Cardiomyopathy
Keywords
stem cell implantation, coronary artery disease, left ventricular assist device

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem cells implantation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Allogeneic stem cells implantation
Primary Outcome Measure Information:
Title
Improvement in myocardial perfusion/viability
Description
Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis
Time Frame
12 months
Title
Improvement in myocardial perfusion/viability
Description
Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Morbidity
Description
Major adverse cardiac and cerebrovascular events
Time Frame
12 months
Title
Change in left ventricular function
Description
Change in left ventricular function after combined mechanical and cellular therapy
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyriakos Anastasiadis, MD, PhD, FETCS
Organizational Affiliation
AHEPA University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AHEPA University Hospital
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
21852003
Citation
Anastasiadis K, Antonitsis P, Doumas A, Koliakos G, Argiriadou H, Vaitsopoulou C, Tossios P, Papakonstantinou C, Westaby S. Stem cells transplantation combined with long-term mechanical circulatory support enhances myocardial viability in end-stage ischemic cardiomyopathy. Int J Cardiol. 2012 Mar 22;155(3):e51-3. doi: 10.1016/j.ijcard.2011.07.062. Epub 2011 Aug 17. No abstract available.
Results Reference
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PubMed Identifier
21247486
Citation
Anastasiadis K, Antonitsis P, Argiriadou H, Koliakos G, Doumas A, Khayat A, Papakonstantinou C, Westaby S. Hybrid approach of ventricular assist device and autologous bone marrow stem cells implantation in end-stage ischemic heart failure enhances myocardial reperfusion. J Transl Med. 2011 Jan 19;9:12. doi: 10.1186/1479-5876-9-12.
Results Reference
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PubMed Identifier
22378852
Citation
Ibrahim M, Rao C, Athanasiou T, Yacoub MH, Terracciano CM. Mechanical unloading and cell therapy have a synergistic role in the recovery and regeneration of the failing heart. Eur J Cardiothorac Surg. 2012 Aug;42(2):312-8. doi: 10.1093/ejcts/ezs067. Epub 2012 Feb 29.
Results Reference
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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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