Clinical study

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Acute myocardial infarction is myocardial necrosis caused by acute, persistent ischemia and hypoxia in the coronary arteries. Severe and persistent post-sternal pains are common in clinical settings. Taking rest or nitrates cannot completely relieve patients’ symptoms. Patients often have elevated serum myocardial enzyme activity and progressive ECG changes, which can be complicated by life-threatening conditions including arrhythmia, shock and heart failure.

 

In acute myocardial infarction, coronary atherosclerotic plaques rupture, platelets and coagulation factors are activated, acute coronary thrombosis is developed, resulting in complete luminal obstruction and myocardial ischemia with irreversible necrosis. Acute myocardial infarction can produce a series of complications including arrhythmia, cardiac pump failure, and mechanical breakdown of the heart. 20%-25% of patients with acute myocardial infarction have one or more complications. According to clinical statistics, about 1 million people develop acute myocardial infarction each year in China. Blood supply to the heart would suddenly stop once acute myocardial infarction occurs. At this time, thrombosis in coronary arteries should be cleared by stenting or thrombolysis to allow the heart to regain blood supply. The ideal time to open blood vessels is within 120 minutes after the onset of the disease. A great number of cardiomyocytes will die in every single minute for which treatment is postponed. When duration of myocardial infarction has exceeded 12 hours, existing technical treatments and surgical thrombolysis would not produce obvious effects.

 

Domestic and foreign studies have long been showing that stem cells have the potential to treat acute myocardial infarction. Stem cells can secrete vascular endothelial growth factors, fibroblast growth factors and other cytokines that promote damage repair and angiogenesis, thereby improving ventricular remodeling and cardiac function. Domestic and foreign scholars have conducted clinical research on bone marrow stem cell transplantation for acute myocardial infarction. Their results show that transplantation of bone marrow stem cells can significantly improve cardiac function, and feasibility of this treatment has been confirmed. The results of this study are inspiring. Stem cell treatments will become a new means and approach for clinicians to treat cardiovascular diseases such as myocardial infarction.

 

CardioCell and ALTACO XXI from Kazakhstan each launched a clinical program using ischemia-tolerant human bone marrow mesenchymal stem cell (it-hMSCs) to treat acute myocardial infarction in the US and Kazakhstan respectively: the clinical trial sponsored by CardioCell in the US has entered Phase II, while the one conducted by ALTACO at National Medical Science Center of Kazakhstan has completed. Successful implementation of the Kazak trial resulted in it-hMSCs being approved by the Ministry of Health of Kazakhstan, which marks the start of the official application of it-hMSCs as a AMI therapy in clinical settings. Cultured under hypoxic conditions, Stemedica’s it-hMSCs can easily adapt to ischemic necrotic tissues damaged by the infarction and heal injuries by secreting various repair factors, thus demonstrating remarkable therapeutic effects.

 

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Stemedica’s itMSCs approved by the Ministry of Health of Kazakhstan as a treatment of acute myocardial infarction