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Lack of eligible patients
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic stem cells implantation | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Major adverse cardiac and cerebrovascular events | 12 months |
| Change in left ventricular function | Change in left ventricular function after combined mechanical and cellular therapy |
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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 |
|---|---|---|---|
| 21852003 | 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. | |
| 21247486 |
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| one year |
| Background |
| 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. |
| 22378852 | Background | 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. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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