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

This study is currently recruiting participants.

Verified December 2012 by AHEPA University Hospital

Sponsor:

Information provided by (Responsible Party):

Kyriakos Anastasiadis, AHEPA University Hospital

ClinicalTrials.gov Identifier:

NCT01759212

First received: December 18, 2012

Last updated: December 27, 2012

Last verified: December 2012

History of Changes

Purpose

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	Intervention	Phase
Heart Failure Ischemic Cardiomyopathy	Biological: Allogeneic stem cells implantation	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy Heart Failure

U.S. FDA Resources

Further study details as provided by AHEPA University Hospital:

Primary Outcome Measures:

Improvement in myocardial perfusion/viability [ Time Frame: one year ] [ Designated as safety issue: No ]
Improvement in myocardial perfusion/viability assesed with SPECT segmental analysis

Secondary Outcome Measures:

all-cause morbidity [ Time Frame: one year ] [ Designated as safety issue: No ]
left ventricular function [ Time Frame: one year ] [ Designated as safety issue: No ]
Change in left ventricular function after combined mechanical and cellular therapy
all-cause mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	October 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759212

Contacts

Contact: Polychronis Antonitsis, MD, DSc

+30 2310 994871

antonits@auth.gr

Locations

Greece
AHEPA University Hospital	Recruiting
Thessaloniki, Greece, 546 36
Contact: Polychronis Antonitsis, MD, DSc +30 2310 994871 antonits@auth.gr
Principal Investigator: Kyriakos Anastasiadis, MD, DSc, FETCS
Sub-Investigator: Polychronis Antonitsis, MD, DSc

Sponsors and Collaborators

AHEPA University Hospital

Investigators

Principal Investigator:

Kyriakos Anastasiadis, MD, DSc, FETCS

AHEPA University Hospital

More Information

Publications:

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.

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. Review.

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. Review.

Responsible Party:	Kyriakos Anastasiadis, Associate Professor Kyriakos Anastasiadis, AHEPA University Hospital
ClinicalTrials.gov Identifier:	NCT01759212 History of Changes
Other Study ID Numbers:	AHEPA_CTL_02
Study First Received:	December 18, 2012
Last Updated:	December 27, 2012
Health Authority:	Greece: Ethics Committee

Keywords provided by AHEPA University Hospital:

stem cell implantation
coronary artery disease
left ventricular assist device

Additional relevant MeSH terms:

Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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