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| Name | Class |
|---|---|
| Chung Shan Medical University | OTHER |
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The objective of the present study is to establish the safety and efficacy of MiSaver® Stem Cell Treatment After a Heart Attack (Acute Myocardial Infarction)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | Cells dosage, 0.5x10^7 cells/kg body weight |
|
| Intermediate Dose (aka Effective or High) | Experimental | Cells dosage, 1.6x10^7 cells/kg body weight |
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| Toxic Dose | Experimental | Cells dosage, 5.0 x10^7 cells/kg body weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiSaver® | Biological | Intravenous administration of MiSaver® Stem Cell via peripheral vein access. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events | Number of Adverse Events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricle stroke volume | Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml). | 12 months |
| End diastolic volume | Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (cc) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University Hospital | Taichung | Taichung City | 402 | Taiwan | ||
| HONYA Medical Inc |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Sequential dose escalating
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Single/participant blinded
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| 12 months |
| Left ventricular ejection fraction (LVEF) | Calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume). | 12 months |
| Participants Functional Activity by NYHA Classification | The New York Heart Association (NYHA) Functional Classification is a useful tool for classifying the extent of functional limitations in patients with heart conditions. The system categorizes patients into one of four categories based on the level of limitation they experience during physical activity, with symptoms ranging from mild shortness of breath or angina to more severe breathing difficulties. The NYHA classification focuses specifically on limitations related to physical activity and provides a straightforward approach to assessing a patient's condition. By using this system, healthcare providers can quickly and easily determine the level of functional limitation in their patients and tailor treatment plans accordingly. | 12 months |
| Participants Functional Activity by CCS Classification | The Canadian Cardiovascular Society grading of angina pectoris, also known as the CCS Functional Classification, is a widely used clinical tool that classifies the severity of exertional angina. It allows doctors to assess the degree of angina severity in patients, and subsequently develop a tailored treatment plan. Although there are no definitive therapy guidelines specific to each class, healthcare providers can use the CCS grading system as a framework to guide treatment planning based on the severity of angina and other individual factors such as age and the risk of major cardiac complications. By utilizing the CCS grading system, healthcare providers can ensure that patients receive personalized treatment that addresses their unique needs and circumstances. | 12 months |
| Tainan |
| 74147 |
| Taiwan |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |