Allogeneic Stem Cells Implantation Combined With Coronary Bypass Grafting in Patients With Ischemic Cardiomyopathy
NCT ID: NCT01753440
Last Updated: 2019-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
11 participants
INTERVENTIONAL
2012-11-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stem cells implantation
Patients with severe coronary artery disease and chronic ischemic cardiomyopathy with a LVEF ≤40% who are scheduled for elective CABG according to accepted guidelines. Additional criteria include the following: age \<75 years, history of myocardial infarction (not less than 14 days before the procedure), LVEF ≤40 % assessed with echocardiography, and a distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization.
Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).
Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP).
Interventions
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Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).
Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP).
Eligibility Criteria
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Inclusion Criteria
* Severe coronary artery disease amenable to surgical revascularization according to current guidelines
* History of acute myocardial infarction at least 14 days previously
* Left ventricular ejection fraction (LVEF) ≤ 40% as assessed with echocardiography
* Distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization
* Patient's informed consent obtained
Exclusion Criteria
* Debilitating chronic disease (eg. malignancy or terminal renal failure)
* Concomitant valve surgery
* Previous cardiac surgery
* Malignant ventricular arrhythmias
* Haematologic disease
* Woman in reproductive age
* Severe psychiatric illness
18 Years
75 Years
ALL
No
Sponsors
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AHEPA University Hospital
OTHER
Responsible Party
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Kyriakos Anastasiadis
Professor Kyriakos Anastasiadis
Principal Investigators
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Kyriakos Anastasiadis, MD, PhD FETCS
Role: PRINCIPAL_INVESTIGATOR
AHEPA University Hospital
Locations
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AHEPA University Hospital
Thessaloniki, , Greece
Countries
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References
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Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW, George R, Lardo A. Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012 Dec 12;308(22):2369-79. doi: 10.1001/jama.2012.25321.
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.
Menasche P. Cardiac cell therapy: lessons from clinical trials. J Mol Cell Cardiol. 2011 Feb;50(2):258-65. doi: 10.1016/j.yjmcc.2010.06.010. Epub 2010 Jun 30.
Other Identifiers
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AHEPA_CTL_01
Identifier Type: -
Identifier Source: org_study_id
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