MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction)

Study Overview
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Brief Summary
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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)

Official Title
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Safety and Preliminary Efficacy Study of Intravenous Administration of MiSaver® (Myocardial Infarction Saver) After Acute Myocardial Infarction, a Phase I/IIa Clinical Trial.

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Biological: MiSaver®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential dose escalating
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose<br>Cells dosage, 1/vial for every 20kg body weight. | Biological: MiSaver®<br>* Intravenous administration of MiSaver® Stem Cell via peripheral vein access.<br>* Other names: stem cells;|
| Experimental: Intermediate Dose<br>Cells dosage, 1/vial for every 10kg body weight. | Biological: MiSaver®<br>* Intravenous administration of MiSaver® Stem Cell via peripheral vein access.<br>* Other names: stem cells;|
| Experimental: Toxic Dose<br>Cells dosage, 2.5/vial for every 10kg body weight. | Biological: MiSaver®<br>* Intravenous administration of MiSaver® Stem Cell via peripheral vein access.<br>* Other names: stem cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Emergent Adverse Events | Number of Adverse Events | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Attack