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| Name | Class |
|---|---|
| FCB-Pharmicell Co Ltd. | UNKNOWN |
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Early reperfusion strategies in tandem with remarkable advances in drugs and devices for treating myocardial infarction (MI) have contributed to a reduction in early mortality, but cardiovascular disease remains the leading cause of death worldwide. Current management strategies cannot solve the problem of cardiomyocyte loss and consequent progression of heart failure. In this respect, stem-cell therapy has shown potential benefits for repairing the damaged myocardium. Mesenchymal stem cells (MSCs) have been considered to be attractive therapeutic candidates because of their high capacity for replication: paracrine effect: ability to preserve potency: and because they do not cause adverse reactions to allogeneic versus autologous transplants. Intracoronary injection of stem cells seems to be safe, but only one clinical trial using MSCs via the intracoronary route in the setting of acute myocardial infarction (AMI) has been carried out. The investigators therefore assessed the safety and efficacy of intracoronary autologous bone marrow (BM)-derived human MSCs in patients with AMI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cell treatment group | Active Comparator |
| |
| Control group | Placebo Comparator | All patients were required to have successful revascularization of an infarct-related artery on coronary angiography at the time of randomization. All patients received aspirin (300 mg loading dose, then 100 mg daily) and clopidogrel (600 mg loading dose, then 75 mg daily) with optimal medical therapy according to the American College of Cardiology (ACC)/ American Heart Association (AHA) guidelines for treatment of ST-segment elevation myocardial infarction (STEMI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cell | Drug | Route : intracoronary injection Frequency : single dose of autologous bone-marrow derived mesenchymal stem cells Dosage : 1x1000000 cells/kg Duration : mean injection duration approximately 4 weeks after primary percutaneous coronary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute changes in global LVEF by SPECT | Absolute changes in global left ventricular ejection fraction (LVEF) as measured by SPECT 6 months after cell infusion | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in left ventricular end-diastolic volume (LVEDV) | baseline and 6 months | |
| Changes in left ventricular end-systolic volume (LVESV) | baseline and 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Hwan Lee, MD, PhD | Yonsei University Wonju College of Medicine, Wonju Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Wonju College of Medicine, Wonju Christian Hospital | Wŏnju | Gangwon-do | 220-701 | South Korea | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24431901 | Derived | Lee JW, Lee SH, Youn YJ, Ahn MS, Kim JY, Yoo BS, Yoon J, Kwon W, Hong IS, Lee K, Kwan J, Park KS, Choi D, Jang YS, Hong MK. A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction. J Korean Med Sci. 2014 Jan;29(1):23-31. doi: 10.3346/jkms.2014.29.1.23. Epub 2013 Dec 26. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Control group | Drug | No additional treatment of mesenchymal stem cells |
|
| Changes in regional wall motion score index (WMSI) by Echocardiography |
| baseline and 6 months |
| Major adverse cardiac event (MACE) | MACE was defined as the composites of any cause of death, myocardial infarction, revascularization of the target vessel, re-hospitalization for heart failure, and life-threatening arrhythmia. | 6 months |
| Inha University Hospital |
| Inchon |
| 400-711 |
| South Korea |
| Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D018754 | Ventricular Dysfunction |
| D008722 | Methods |