This trial is a Phase II, multicenter clinical study. The purpose of this trial is to evaluate the safety and efficacy of MiSaver, a cellular therapy product, in patients who have experienced an acute myocardial infarction (AMI). Specifically, the study aims to assess the improvement in left ventricular function of the heart following the administration of MiSaver, as well as to determine the safety of using stem cell therapy in these patients.
This trial will employ a single-blind design (subject-blinded), meaning that the participants will not be aware of whether they are receiving MiSaver or standard treatment, while the researchers will have this information. This design helps ensure transparency and adherence to ethical standards while also providing valuable clinical insights.
By utilizing randomization, we can enhance the reliability and comparability of the study results. A portion of the participants will receive MiSaver, while the others will undergo standard treatment. This allows for a direct comparison of the two therapeutic approaches to determine their respective efficacy.
The primary objective of this trial is to evaluate the safety and efficacy of MiSaver, in the treatment of patients with acute myocardial infarction (AMI). To achieve this, we will collect comprehensive participant data, including assessments of cardiac function, records of cardiac events, and quality-of-life surveys. By analyzing these data, we aim to gain a deeper understanding of the benefits and limitations of this treatment approach.
Age ≥ 45 years, BMI ≤ 32
Patients diagnosed with acute myocardial infarction by a cardiologist, within 36 hours to 7 days post-diagnosis, and able to complete cell infusion within this period.
Left ventricular ejection fraction (LVEF) ≤ 45%, hemodynamically stable patients who do not require vasopressor support within 24 hours.
Patients with a history of coronary artery disease, who have previously undergone percutaneous coronary intervention or coronary artery bypass graft surgery, may also be included upon evaluation by a cardiologist.
Age < 45 years, BMI > 32.
Women who are planning to become pregnant, are pregnant, or are breastfeeding
Immunodeficiency diseases caused by infection , such as Human Immunodeficiency Virus (HIV).
Patients diagnosed as needing coronary artery bypass surgery or potentially requiring coronary revascularization surgery within the next 6 months.
Parallel
Cord Blood Nucleated cells
Biological/VaccineMiSaver will be administered via peripheral intravenous injection. Based on dosage, the experimental group will be divided into two subgroups: 0.5 × 10⁷ or 1.6 × 10⁷ nucleated cells per kilogram of patient body weight.
AE
Collection and assessment of all adverse events within 12 months after treatment, including type, incidence, and severity.
GVHD
Proportion of patients developing Graft Versus Host Disease (GVHD) at the 3rd month after infusion.
cardiovascular composite events
Number and frequency of cardiovascular composite events, including myocardial infarction and stroke.
LVEF
Evaluation of treatment efficacy through 2D echocardiography to assess left ventricular volume and ejection fraction.
Cardiovascular-related mortality
Cardiovascular-related mortality record within 12 months after treatment
Incidence of new myocardial infarction (NMI)
Incidence of new myocardial infarction (NMI), with a clear definition provided, such as symptoms, elevated cardiac enzymes, and ECG changes. d. Non-fatal stroke.
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