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The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of a novel mesenchymal precursor cell type (iMP) in patients with ischemic cardiomyopathy at the time of coronary artery bypass grafting.
This study aims to investigates in situ cardiac regeneration utilizing precision delivery of a novel mesenchymal precursor cell type (iMP) during coronary artery bypass surgery (CABG) in patients with ischemic cardiomyopathy (LVEF < 40 %). Preoperative scintigraphy imaging (SPECT) will be used to identify hibernating myocardium not suitable for conventional myocardial revascularization for iMP implantation. iMP cells will be implanted intramyocardially in predefined viable peri-infarct areas that show poor perfusion, which could not be grafted due to poor target vessel quality. Postoperatively, SPECT will be used to identify changes in scar area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cells implantation | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP). | Procedure | Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP). |
|
| Measure | Description | Time Frame |
|---|---|---|
| iMP-related adverse events | Major adverse cardiac and cerebrovascular events including death, postoperative myocardial infarction, need for revascularization, stroke, hospitalization for worsening heart failure, myocardial rupture, infectious myocarditis, or sustained ventricular arrhythmias. | 12 months |
| Hypersensitivity | Hypersensitivity reaction (fever, urticaria, hemolytic anemia, hypotension, immune thrombocytopenia) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Scar reduction | Myocardial scar size reduction assessed with SPECT | 4 months |
| Scar reduction | Myocardial scar size reduction assess with SPECT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyriakos Anastasiadis, MD, PhD FETCS | AHEPA University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHEPA University Hospital | Thessaloniki | 546 36 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23117550 | Background | 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. | |
| 21852003 |
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| 12 months |
| LVEF | Left ventricular ejection fraction | 12 months |
| Change in quality of life | Quality of life evaluated with MLHFQ | 12 months |
| Background |
| 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. |
| 20600097 | Background | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D007291 | Inosine Monophosphate |
| ID | Term |
|---|---|
| D007292 | Inosine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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