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Clinical tests for commercialization II/III are taking place in Yonsei University Shinchon Severance Hospital, Wonju Christian Hospital and Inha University Hospital for acute myocardial infarction as part of the heart disorder drug research. Clinical tests are carried out by mass-cultivating mesenchymal stem cells derived from the patient's own body and inserting it back into the plexus coronarius using cardiac catheterization. We plan to apply for product authorization once objective data is derived from clinical tests of various facilities.
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Disorders of the heart like acute myocardial infarction is the second highest cause of death after brain blood disorders, and is a major organ disorder that is continuously increasing due to an increase in ischemic heart disease. In addition, there is a high chance of chronic heart disease after myocardial infarction and the survival rate is low, meaning the patient has to take medicine all his life. It is a disorder that not only lowers the quality of an individual's life, but also has a serious social and economic effect. Korean welfare statistics show that heart disease patients are rapidly rising. |
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Myocardial infarction is usually caused by sedated blood or cholesterol in the coronary artery that is linked to the left heart. The supply of blood and air to part of the heart muscle is blocked leading to destruction of myocardial cells, and as a result the myocardially infarcted part becomes a dead structure. The current treatment is to make the blocked artery flow again early on in the disease and reduce the size of the myocardial infarction, and improve the function of the left heart to raise the chance of survival. However most patients do not find the disorder in time and even if the treatment is done recovery of myocardial cell is impossible, and due to a lower heart function it can only lead to chronic heart disease. Various medications are taken along with this method, but myocardial recovery is impossible and the death rate os ultimately rising. |
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Heart transplant is necessary to recover the functions of the heart, but there is the problem of a limited number of heart donors, and also problems such as structural rejection reactions and costs, so only a few patients actually choose this method. A genetic method for blood and myocardial recovery was recently introduced, but the results are too meager to be used clinically yet. Therefore the need of a new cell replacement therapy that replaces dead myocardial cells recovers damaged ones is rising. |
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Stem cells that can be used for treatment of myocardial infarction are surviving myocardial stem cells, precursor cells from blood vessels, stem cells from bone marrow, mesenchymal stem cells and undivided bone marrow monocytes, and these are being adapted in clinical tests for the treatment of myocardial infarction. |
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Resident cardiac stem cells can be separated from myocardial and blood vessel cells in the heart and in theory are ideal and effective cells that can move directly into the heart and help improve the functions of myocardial cells and the coronary artery, but they need to be re-programmed in order to branch into heart cells. |
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Endothelial progenitor cells have a characteristic of takin up a place in new parts of blood vessels, and can branch into blood vessel cells. German researchers recently carried out clinical tests using precusor cells inside blood vessels on patients of acute myocardial infarction and reported that heart functions got better, but this method has its limit because the number of blood vessel precusor cells and the blood vessel formation capacity of patients of chronic coronary artery disease decreased. |
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The muscle cell of the skeletal muscle is a precusor cell that exists as the anestrus in the cell membrane of a developed striated muscle. Extracting the skeletal muscle of a patients and amplifying it to transplant it to the myocardium showed an improvement in myocardium function, but serious arrythmia occurred in many cases causing a need for defibrillator insertion surgery. |
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Mesenchymal stem cells are known as stem cells that only exist in small amounts in the bone marrow (2-5 in 1¡¿10? or 10?6 precusor cells) but they can be amplified by more than 1 billion times outside the body without losing their characteristics, and can branch into osteogenic, chondrogenic, adipogenic, neorogenic, motogenic and angiogenic areas, and so is highly sought as a treatment drug of a different kind that goes beyond the idea of existing medicine. |
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Mesenchymal stem cells especially have the advantage of contributing recovery of not only myocardial cells but also of blood vessels in animal models of acute myocardial infarction, using 10?~10? cells. Chen and others proved in early clinical test in 2004 that treatment of patients of acute myocardial disorder using patients' own mesenchymal stem cells inserted into the coronary artery proved to be safe and recovered the heart functions of patients. Recently, Katritsis and others also proved that inserting 1~2¡¿10? cells into the coronary artery of patients of acute myocardial infarction was safe and had treatment effects. |
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FCB-Pharmicell is using patients' own mesenchymal stem cells derived from the pelvic bone marrow cells, and developing a new bio-medicine in the form of a stem cell drug the maximizes the "effect" on myocardial infarction. |
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Clinical trial phase-II/III for commercial purposes is in progress for acute myocardial infarction at Yonsei University-Shinchon Severance Hospital, Wonju Christian Hospital, and Inha University Hospital. We plan to finish these trials by the end of 2009 and apply for authorization to start commercialize the products in 2010. |
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Brain application 40-0726298 (Brand name for Acute Myocardial Infarction drug) |
