MEDI COLUMN

    Stem Cell Therapy Products broken down into easy words
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    Stem Cell Therapy Products
    broken down into easy words

    Common knowledge from Hyeonsu Kim,
    the director of the hospital and developer of the world’s first stem cell therapy product.

    The purpose of medical science is to prevent and treat diseases. At least, so far, before the regenerative medicine has recently been drawing attention and changed the whole paradigm. The objective of regenerative medicine lies in replacing damaged organs or tissues with new tissues. It is a very close approach to the very fundamental solution medical science has been dreaming, and in the middle of it, there is ‘stem cell’.

    Up to now, there have only been 7 stem cell therapy products that have been government-approved as drug medicine. Among them, the world’s first stem cell therapy product was born in the Republic of Korea in July 2011.

    Soeum Physiological Type with Cold Body
    Soeum Physiological Type with Cold Body
    Company Product Main Ingredients Diseases Approval Date Approved Country
    Pharmicell Cellgram autologous bone marrow-derived mesenchymal stem cells left ventricular ejection built in acute myocardial infarction 07 / 2011 Korea
    Medi-Post CARTISTEM ® UCB-MSC Treatment to of the patella loss of osteoarthritis patient 01 / 2012 Korea
    Anterogen Cupistem® injection autologous bone marrow-derived mesenchymal stem cells Clonal fistula 01 / 2012 Korea
    Osiris Therapeutics Prochymal marrow-derived mesenchymal stem cells GVHD (Graft versus host disease) 05 / 2012
    06 / 2012
    09 / 2015
    Canada
    New Zealand
    Japan(Under conditions)
    Corestem NEURONATA-R autologous bone marrow-derived mesenchymal stem cells Amyotrophic Lateral Sclerosis (Lou Gehrig’s disease) 07 / 2014 Korea
    Chiesi Holoclar Stem cells derived from autologous corneal epithelium Eye troubles from burns 02 / 2015 Italia (Under conditions)
    Terumo Heart Sheet Human skeletal muscle-derived cell sheet Heart failure 2015 Japan(Under conditions)

    As seen in the above table, stem cell therapy products are mostly focused on rare diseases and are expected to give hopes to the patients with no therapeutical methods, and as a result, the market is rapidly growing.

    In South Korea, there have been remarkable examples where a patient, with the four limbs paralyzed, become able to walk after a stem cell therapy, a patient with liver cirrhosis can only be cured by a liver transplantation as an only option. Otherwise, this patient might face death. Even this patient with severe condition gets better after a stem cell therapy.

    As such examples, stem cells are with us deeply in our daily lives, but the lack of cognition has been the problem leading us to the result with no therapeutic value or illegal stem cell therapy with side effects.

    It is required to check what is stem cell is, to prevent such harm damages, how to treat them and what are the things to check before choosing a medical institution for stem cell therapy

    CHECK POINT 1. What is a stem cell?

    A stem cell is a mother cell to cells that construct our body and is a dissociated cell. We can divide Stem cells into: ▲Embryonic stem cell, ▲Induced pluripotent stem cell, and ▲adult stem cell.

    Embryonic stem cells can differentiate into any cells but also have the safety issues such as: forming tumors or immune rejection response, and ethical problems, and so it isn’t easy to be used a drug medicine just now. Same goes for the Induced pluripotent stem cell.

    Adult stem cells carry out the role in maintaining and treat tissues and exist in various tissues of an adult and are free from the safety issues and ethical problems. They can be gained from bone marrows, fat, skin muscles. Stem cell therapy products in existence now were born from adult stem cells and take 95% of clinical researches about stem cells studied over the world.

    CHECK POINT 2. How do stem cell therapy products work and which disease are they targeting?

    We are collecting each stem cell therapy products from different sources such as bone marrow, fat, or cord blood. However, when they are made into therapy products and injected to into human bodies, they exist for certain specific period and disappear and during the period the principles for them to regenerate the cells are the same.

    Other than the diseases (Please refer to the table above) that the 7 released stem cell therapy products are approved for, there are more of various diseases expected to be cured by stem cell therapy products. Especially in case of CellgramⓇ-AMI of Phamicell, the world’s firstly approved, has been studied over various diseases such as myocardial infarction, liver cirrhosis, stroke, Critical limb ischemia, erectile dysfunction, or anti-aging. I would like to discuss how the stem cell therapy products work in examples of myocardial infarction and liver cirrhosis.

    Cardiovascular disease and stem cell therapy

    Myocardial infarction is the typical example of adult diseases. The conventional treatment method is to insert a stent in the blocked blood vessel of the heart, so it does not shrink again. And of course, constant medication afterwards is needed to prevent the stenosis. However, if we find it late or disease symptom is heavy, though you dig the blocked blood vessel, the heart tissue may be damaged and can cause heart failure. Slight heart failure may require constant medication to reduce the burden to the heart but serious severe heart failure can make you suffer to the level where you cannot proceed with the socioeconomic activities and require a heart transplantation.

    Once damaged heart tissues are not regenerated, and patients with such diseases acutely need stem cell therapy products. In Korea, it is approved as drug medicine in 2011, after 5 years of constant uses of it. It has been showing improvements in heart problem. Patients with heart failure can have remarkably better life quality even with a slight improvement. For patients with minor heart failure, it can show improvements in symptoms and for patients with severe heart failure, it can help maintain the heart to function until they can take heart transplantation. Over 10 years of clinical trials and the uses at medical fields over the last 5 years, there haven’t been any side effect cases from serious heart failure, the case of death, nor cancer development.

    Liver cirrhosis and stem cell therapy

    There is a saying: Liver is a silent organ.‘ That’s to say, at its early liver cirrhosis stage, it isn’t likely for the patient to feel a symptom and they confront the seriousness when the liver cirrhosis takes to some stage. Fibrosis of liver brings various complications and at in worse cases, the liver function decline can lead to liver failure and critical conditions. When liver cirrhosis progresses and arrives to at its late stage, the possibility of liver cancer increases and liver transplantation is a solution as a final surgery treatment, but it does not mean a full recovery. Liver transplantation costs a lot and it is not easy to find a donor. Even if you manage to have a liver transplantation, you will still need to take immunosuppressant for the rest of your life and practically it is not easy to afford for the medical expenses of the high price.

    The existing treatment for liver cirrhosis is to avoid or remove the causes of inflammation or calm down the level, but now with the methods with stem cells, it has been confirmed that stem cells can regenerate liver cells and lower the fibrosis level by one step. It’s good news to for liver cirrhosis patients. If a stem cell treatment is applied at a right timing, patients’ liver cells will be regenerated and the fibrosis condition can be improved and as a result, the recovery of liver functions can be expected.

    CHECK POINT 3. If you need a safe stem cell, do check!

    Stem cell therapy products are made from many manipulation works of living cells and so it contains the high possibility to have pollution in the process. Therefore, it is very important for patients to check if the medical institution they are about to have stem cell therapy products injected uses a government-approved stem cell therapy products. Please refer to [Table 1] above to check government-approved stem cell therapy products.

    If not approved, it means that would be a procedure field where stem cells from bone marrow, far, or cord blood, without a cultivation process, separated and used. Such stem cell treatment can have remedial value in a minor disease in a limited part but such stem cells simply separated only contain a very small number of mesenchymal stem cells that is effective in actual treating, and it cannot promise a safety or remedial value for patients with serious and/or rare diseases or patients in need of a whole body injection. Therefore, if you are a patient and are considering treatment with stem cells, you need to have your disease(s) accurately examined and chose a medical institution carefully depending on their suitability.

    CHECK POINT 4. Stem cell therapy products are not a cure-all.

    Stem cell does not heal everything. A complete recovery is not an easy thing to achieve in any diseases and stem cell therapy products are also a kind of drug medicine to have the symptoms and functions of rare diseases improved, and you cannot vaguely rely on it with overinflated hopes. However, what is guaranteed is that stem cells are curing diseases modern medicine has been struggling with and it is going to be a general treatment of various diseases before this age goes. Stem cells will save more people and shock the world.