NCT01759212

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2 heart-failure

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

9.8 years

First QC Date

December 18, 2012

Last Update Submit

July 20, 2022

Conditions

Heart FailureIschemic Cardiomyopathy

Keywords

stem cell implantationcoronary artery diseaseleft ventricular assist device

Outcome Measures

Primary Outcomes (2)

  • Improvement in myocardial perfusion/viability

    Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis

    12 months

  • Improvement in myocardial perfusion/viability

    Improvement in myocardial perfusion/viability assessed with SPECT segmental analysis

    24 months

Secondary Outcomes (2)

  • Morbidity

    12 months

  • Change in left ventricular function

    one year

Study Arms (1)

Stem cells implantation

EXPERIMENTAL

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

Interventions

Allogeneic stem cells implantationBIOLOGICAL
Stem cells implantation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not willing to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 546 36, Greece

Location

Related Publications (3)

  • 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.

    PMID: 21852003BACKGROUND

  • 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.

    PMID: 21247486BACKGROUND

  • 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.

    PMID: 22378852BACKGROUND

MeSH Terms

Conditions

Heart FailureCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Kyriakos Anastasiadis, MD, PhD, FETCS

    AHEPA University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Kyriakos Anastasiadis

Study Record Dates

First Submitted

December 18, 2012

First Posted

January 3, 2013

Study Start

October 1, 2012

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Locations

GR(1)