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Through the injection of Hearticellgram-AMI into acute myocardial infarction patients who are the primary targets of the drug, long term efficacy in the improvement of the left ventricle ejection fraction upon the first cell treatment is to be evaluated and compared with the current existing treatments (contemporary drug treatment).
This study will also compare the efficacy and safety of single dose of hearticellgram-AMI.
We are enrolling a patient who had successful conventional percutaneous coronary intervention after acute myocardial infarction. Patients are allocated to one of three groups (group1=comparator, group2= one dose of hearticellgram-AMI).
single dose of hearticellgram-AMI have been attained new drug approval from MFDS (related to NCT01392105).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | After implementing PCI, contemporary drug treatment is conducted. *Contemporary drug treatment is a general drug treatment (Unfractionated heparin, Low Molecular Weight Heparin, Glycoprotein llb/llla inhibitor, Aspirin, clopidogrel or Ticlopidine, Nitrate, ACE inhibitor or ARB, β-blocker, CCB, Diuretics, Statin, etc.) | |
| Single dose of Hearticellgram-AMI | Experimental | Within 30 days (+ / -7 days) after aspirating bone-marrow, approximately 1×10^6/kg (refer to usage/dosage according to mass) of autologous bone marrow-derived mesenchymal stem cells are adminstered into the infarct coronary artery using balloon tipped catheter. Furthermore, contemporary drug treatment is conducted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearticellgram-AMI | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| LVEF amount of change | Left ventricle ejection fraction (LVEF) measured 13 months after the cell treatment (MRI measurement) | 13 months after the cell treatment |
| Measure | Description | Time Frame |
|---|---|---|
| LVEF amount of change | Left ventricle ejection fraction (LVEF) measured 6 months after the cell treatment (MRI measurement) | 6 months after the cell treatment |
| Infarct size amount of change | Change in infarct size evaluated by MRI at 6 and 13 months compared to before administration |
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Inclusion Criteria:
As of the date of written consent, between 20 and 75 years of age
Those with less than 50% of the left ventricular ejection fraction (LVEF) on echocardiography performed after percutaneous coronary intervention (PCI) (evaluated by investigator)
Who has been identified as an acute myocardial infarction in any of the following on an electrocardiogram (12-lead electrocardiography, ECG) performed before PCI
Those identified as anterior wall MI
Who meet the above criteria and have successfully reperfused within 72 hours after the onset of chest pain
Who can conduct clinical trials according to the clinical trial protocol
Who has consented in writing to voluntarily participate in this clinical trial (owner or legal representative)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeonghan Yoon, Ph.D. M.D. | Wonju Severance Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangwon National University Hospital | Chuncheon | South Korea | ||||
| Chonnam National University Hospital |
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| 6, 13 months after the cell treatment |
| Left ventricle end systolic size change | Change in left ventricular end systolic size evaluated by MRI at 6 months and 13 months compared to before administration | 6, 13 months after the cell treatment |
| Left ventricular end-diastolic size change | Change in left ventricular end diastolic size evaluated by MRI at 6 months and 13 months compared to before administration | 6, 13 months after the cell treatment |
| Incidence of critical heart events | The incidence of major cardiac events (death, hospitalization for cardiac shock or heart failure, recurrence of myocardial infarction, occurrence of severe arrhythmias) within 24 months after administration | Within 24 months after the cell treatment |
| Heart rate variability change amount | Heart rate variability change at 13 months compared to before administration (24 hours Holter measurement) | 13 months after the cell treatment |
| Left ventricular local wall movement disorder index change | The amount of change in the left ventricular local wall movement impairment index evaluated by echocardiography at 6 and 13 months compared to before administration | 6, 13 months after the cell treatment |
| N-terminal pro-brain natriuretic peptide (NT-proBNP) change | Changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) at 6 and 13 months compared to before administration | 6, 13 months after the cell treatment |
| Gwangju |
| South Korea |
| Yongin Severance Hospital | Gyeonggi-do | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Inha University Hospital | Incheon | South Korea |
| Chungnam National University Hospital | Jungnam | South Korea |
| Catholic University of Korea, Seoul ST. Mary's Hospital. | Seoul | South Korea |
| Korea University Medicine | Seoul | South Korea |
| Severance Hospital, Yonsei University College of Medicine | Seoul | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | South Korea |