# Four Stem Cell Therapy Products Approved in Korea | OSANG > An overview of the approved indications and application criteria for Cartistem, Hearticellgram-AMI, Cupistem, and Neuronata-R, four stem cell therapy products approved in Korea. - Official page: https://osns.co.kr/en/stem-cell/ - Organization: OSANG Neurosurgery ## Page content ## Stem Cell Clinic ## domestic permit 4 types of stem cell therapy Each treatment has different cell sources, approved diseases, and application methods. Osang Neurosurgery provides information on the scope and standards of official approval before the name. Cell + Evidence = CARE ## We're not just talking about possibilities. Check the approved standards first. Care For ## Patient · Condition · Safety Stem cell is one word, but the origin, approval target, and administration environment of the cells are different.You can accurately understand the treatment by looking at the three criteria together. Approval Standard ## Even if it is an approved treatment There are different criteria to check. Ministry of Food and Drug Safety product approval is a standard for the targets and methods set for each product. You must determine whether it is right for the patient by looking at the diagnosis and approval conditions together. ### What cell does it start in? ### For which patients is it approved? ### How to apply it ### Where can it be implemented? Therapy Information ## Approval scope of four treatments We explain each step accurately. Applicability is not determined based on the disease name alone. The officially approved targets, application methods, and limitations of each product are summarized in easy-to-understand language. ### Cartistem This is an allogeneic cord blood-derived treatment for some patients whose knee cartilage is deeply damaged due to degenerative changes or repeated trauma. It is approved for the treatment of ICRS grade 4 cartilage defects in which the knee cartilage is deeply damaged down to the bone due to degenerative changes or repetitive trauma. - When the treatment area is the knee joint - Cartilage defects caused by degenerative changes or repeated trauma - When cartilage damage is confirmed as ICRS grade 4 - If you pass a surgical suitability evaluation including joint alignment and general condition - Simple knee pain or early arthritis - Diseases of joints other than the knee - K&L grade 4, terminal arthritis based on X-ray - Chronic inflammatory and autoimmune arthritis such as rheumatoid arthritis - Severe leg deformation that makes it difficult to expect treatment results - In case of hypersensitivity to related ingredients, anesthetics, gentamicin, etc. No. This is a treatment that uses allogeneic mesenchymal stem cells derived from donated umbilical cord blood. No. The damaged cartilage area is surgically prepared, a treatment agent is implanted, and a rehabilitation process is performed. ICRS and K&L are different evaluation standards. Cartilage defects must be ICRS grade 4, but K&L grade 4, which is terminal arthritis on X-ray, is a contraindication to administration. For the most up-to-date permits, please check official sources first. ### Hearticellgram-AMI It is an autologous bone marrow-derived treatment for selected patients with acute myocardial infarction who have undergone coronary angioplasty within a limited period of time. It is approved for the purpose of improving heart function in patients who undergo coronary angioplasty within a specified time after acute myocardial infarction and whose left ventricular ejection fraction is less than 40%. - When diagnosed with acute myocardial infarction - When blood flow is restored through coronary angioplasty within 72 hours from the start of chest pain - When the left ventricular ejection fraction is less than 40% - When autologous bone marrow collection and cardiac catheterization are possible - Myocardial infarction that occurred a long time ago - Common chronic heart failure or simple chest pain - For the treatment of neurological diseases such as cerebral infarction and Parkinson's disease - If you cannot undergo cardiac catheterization or coronary angiography - If coronary artery blood flow disorder remains before administration - Use of cells from someone else rather than the patient's own bone marrow cells No. This is a treatment applied to some patients who have already suffered an acute myocardial infarction and have had their blood vessels reopened within a set time. No. It is administered into the coronary artery in an environment where cardiovascular intervention is possible. No. Hearticellgram-AMI is eligible for approval for patients with acute myocardial infarction who meet all conditions. ### Cupistemju It is an autologous cell therapy that injects the patient's own fat-derived cells into the fistula caused by Crohn's disease. It is approved for the treatment of fistulas caused by Crohn's disease. It is not a drug that treats all symptoms of Crohn's disease, but rather targets the fistula. - When a fistula occurs due to Crohn's disease - When the location, length, and diameter of the fistula can be evaluated - When autologous fat tissue can be collected and cells can be manufactured - When infection and Crohn's disease activity are managed to a level where surgery is possible - General anal disease or fistula not related to Crohn's disease - Severely active Crohn's disease - If you have a bacterial infection - When it is not possible to collect your own fat - In case of hypersensitivity to related ingredients, anesthetics, fibrin glue, etc. - For treatment of simple abdominal pain, diarrhea or enteritis No. It is a prescription drug made by isolating and culturing mesenchymal stem cells from harvested fat. No. Applicable for approval are fistulas caused by Crohn's disease and existing Crohn's disease treatment and management are still required. No. Since it is an autologous cell therapy product made from the patient's own cells, it can only be used by the patient. ### Neuronata-Alju It is an autologous bone marrow-derived cell therapy for some patients with Lou Gehrig's disease that meets all current approval criteria. It is approved to slow the progression of some patients with amyotrophic lateral sclerosis (ALS) who are taking Riluzole together and whose rate of functional decline has been confirmed to be within the approved standard in repeated tests. - If you are diagnosed with amyotrophic lateral sclerosis, or ALS - If you are taking riluzole together - When the ALSFRS-R functional decline rate is confirmed to be less than 1.02 points per month - When autologous bone marrow collection and intrathecal administration are possible - When applied collectively to all ALS patients - When the rate of functional decline is faster than the current approval standard - Other neurological diseases such as Parkinson's disease, cerebral infarction, dementia, etc. - Random use without concomitant use of riluzole - When autologous bone marrow cannot be collected - In case of bleeding tendency or hypersensitivity to related ingredients or antibiotics No. Repeated evaluations are required to calculate actual progress and meet all current official licensing criteria. No. The approved goal is to slow the rate of functional decline in some patients who meet the conditions. No. Neuronata-R is not an approved treatment for Parkinson's disease or cerebral infarction. Evidence Standard ## Before the name of the treatment, Check official licensing information. For the latest efficacy/effects, usage/dosage, contraindications, and adverse reactions, you must first check the latest approvals from the Ministry of Food and Drug Safety. View the approval conditions for each product, including disease name, severity, and application method. We provide guidance based on MFDS Drug Safety Korea and the manufacturer's official information. At A Glance ## Compare your treatments at a glance. Even if the stem cell therapy is the same, it differs in whether it is applied using own cells or donor cells, and in what area and method it is applied. ## Important notice This Markdown alternative helps search and AI tools understand the public page accurately. It provides general health information and does not replace an individual diagnosis or treatment.