Safety and Preliminary Efficacy Study of Intravenous Administration of MiSaver® (Myocardial Infarction Saver) After Acute Myocardial Infarction, a Phase I/IIa Clinical Trial.
| Registry | NCT04050163, acronym MiSaver® |
|---|---|
| Status | Completed |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; non randomized, sequential, masking: single, treatment |
| Enrollment | 11 (Actual) |
| Sponsor | Honya Medical Inc (Industry); collaborators: Chung Shan Medical University |
| Conditions | Myocardial Infarction |
| Interventions | MiSaver® (Biological) |
| Dates | start 2021-01-26, primary completion 2023-05-04, completion 2023-05-04, first posted 2019-08-08, last updated 2024-03-29 |
| Locations | 2 sites in Taiwan |
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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)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Low Dose | Experimental | Biological: MiSaver® | Cells dosage, 0.5x10\^7 cells/kg body weight |
| Intermediate Dose (aka Effective or High) | Experimental | Biological: MiSaver® | Cells dosage, 1.6x10\^7 cells/kg body weight |
| Toxic Dose | Experimental | Biological: MiSaver® | Cells dosage, 5.0 x10\^7 cells/kg body weight |
Sex: All, ages: 20 Years to 80 Years
Inclusion Criteria: * Patients aged 20\~80 * Acute Myocardial Infarction 1 to 10 days * Cardiac enzyme CK-MB or Troponin > 2X of high-end normal value * ST-elevation on EKG (STEMI) * Presence of regional wall motion abnormality * Left ventricular ejection fraction (LVEF) of ≤40% * Hemodynamically stable past 24 hour * Participants with adequate pulmonary function * Peripheral artery oxygen saturation ≥97% * Karnofsky performance status scores of ≥60. Exclusion Criteria: * Age <20 or >80 * Pregnant or breast feeding * Positive adventitious infections (such as HIV, hepatitis ) * Revascularization via coronary artery bypass surgery is required * Coronary revascularization procedures is anticipated during the 6-month study period * Severe aortic or mitral valve narrowing * Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG) * Short of breath unable to receive PCI examination or treatment * Malignant tumor * Hematopoietic dysplasia * Severe organ disease * With less than 1 year of life expectancy * Chronic kidney disease with CCr<20ml/min * Kidney disease on renal dialysis
| Facility | City | Country | Status |
|---|---|---|---|
| Chung Shan Medical University Hospital | Taichung, Taichung City | Taiwan | |
| HONYA Medical Inc | Tainan | Taiwan |