Myocardial Infarction
Conditions
Keywords
Heart Attack
Brief summary
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)
Interventions
BIOLOGICALMiSaver®
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Sponsors
Chung Shan Medical University
Honya Medical Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single/participant blinded
Intervention model description
Sequential dose escalating
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events | 12 months | Number of Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricle stroke volume | 12 months | Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml). |
| End diastolic volume | 12 months | Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (cc) |
| Left ventricular ejection fraction (LVEF) | 12 months | 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). |
| Participants Functional Activity by NYHA Classification | 12 months | 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. |
| Participants Functional Activity by CCS Classification | 12 months | 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. |
Countries
Taiwan
Outcome results
None listed