A Randomized,Open labEled, muLticenter Trial for Safety and Efficacy of Intracoronary Adult Human Mesenchymal stEm Cells Acute Myocardial inFarction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 10
- 主要终点
- LVEF amount of change
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •ST-segment elevation 0.1 mV in two or more limb leads or
- •0.2 mV elevation in two or more contiguous precordial leads indicative of acute myocardial infarction (AMI)
- •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)
排除标准
- •Who have not been diagnosed with malignant blood diseases (acute myelogenous leukemia, acute lymphocytic leukemia, non-Hodgkins lymphoma, Hodgkins lymphoma, multiple myelopathy) within 5 years of screening criteria
- •Patients with severe aplastic anemia
- •Patients with solid cancers in their previous medical history (within 5 years)
- •Patients whose blood serum AST/ASL rates are more than three times the normal maximum rate, and whose creatinine rates are more than 1.5 times the normal maximum rate (but AST in myocardial infarction patients can temporarily rise, thus, as decided by the researchers, if there is no damage to the liver function, the rise will not be taken into consideration)
- •Patients who have implemented Coronary Artery Bypass Graft(CABG)
- •Patients with chronic heart failure (patients with medical history of heart failure medical history at least three months before the occurrence of acute myocardial infarction)
- •Patients who cannot proceed with cardiac catheterization
- •Patients who had been continuously taking large doses of steroids (1mg/kg/day) or antibiotics for severe infections from one month prior to registration
- •Patients who had major surgical operations, organ biopsy, or significant external injury as determined by the researcher, within three months before registration
- •Patients who have head injuries or other external injuries after the development of myocardial infarction
- •patients with stroke or transient ischemic attack within six months before registration, patients with history of central nervous system disease (tumor, aneurysm, brain surgery etc.)
- •Patients with low survival ability after cardiopulmonary resuscitation within last 2 weeks.
- •Patients with positive for HIV, HBV, HCV, Syphilis
- •pregnant women or likely to be pregnant or lactating women
- •Patients with drug abuser within last 1 year.
- •Patients with participating other clinical trials with last 1 month.
- •When the possibility of tumor occurrence is seen when the tester judges even one of the tumor marker tests during screening
- •Who are judged to be inappropriate to participate in this test when judged by the examiner
研究组 & 干预措施
Control
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
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.
干预措施: Hearticellgram-AMI (Biological)
结局指标
主要结局
LVEF amount of change
时间窗: 13 months after the cell treatment
Left ventricle ejection fraction (LVEF) measured 13 months after the cell treatment (MRI measurement)
次要结局
- Left ventricle end systolic size change(6, 13 months after the cell treatment)
- Left ventricular end-diastolic size change(6, 13 months after the cell treatment)
- Heart rate variability change amount(13 months after the cell treatment)
- Incidence of critical heart events(Within 24 months after the cell treatment)
- Infarct size amount of change(6, 13 months after the cell treatment)
- Left ventricular local wall movement disorder index change(6, 13 months after the cell treatment)
- LVEF amount of change(6 months after the cell treatment)
- N-terminal pro-brain natriuretic peptide (NT-proBNP) change(6, 13 months after the cell treatment)