Miracell, a leader in advanced regenerative medicine, gains momentum with innovation vouchers.
Miracell is expanding its business through the Innovation Voucher Package program of the Korea SMEs and Startups Agency (KOSME). This program provides voucher support to small manufacturing companies to utilize necessary programs. In 2023, Miracell provided approximately KRW 46.3 billion worth of services to 1,620 promising small businesses, totaling 2,752 cases. Shin Hyun-soon, CEO of Miracell (pictured), stated on the 28th, “Thanks to the Innovation Voucher’s patent applications and domestic and international online advertising support, we have not only promoted our brand but also gained new customers and diversified our revenue streams.” “We have successfully diversified our export markets, and in the first half of this year, we have already surpassed our 2023 target of KRW 1 billion.” Miracell received technical support within the Innovation Voucher program to apply for patents necessary for global market entry.Domestic and international patents are essential for protecting the stem cell extraction technology used in SmartMcell2, building credibility for exports, and securing competitiveness. Although Miracell already possesses patents, the cost of filing patent applications in each exporting country is a significant burden.With the Innovation Voucher program, Miracell was able to reduce its financial burden by filing patent applications in Korea, China, Vietnam, Indonesia, and India.This has resulted in 21 patents related to cell extraction technology filed domestically and internationally. Miracell actively utilized the marketing aspects of the Innovation Voucher program.It ran online advertising, including search and image ads, targeting both domestic and international audiences through Google Ads and Naver.In addition to reducing the cost burden, the advertising was immediately effective because the specialized agency within the Innovation Voucher platform handled the advertising.After receiving support from the Innovation Voucher, the company saw a 208% increase in Google top rankings, a 183% increase in click-through rates, and an influx of new customers both domestically and internationally. This is also led to increased sales, doubling from approximately KRW 5 billion in 2022 to approximately KRW 10 billion in 2023. The number of employees also increased significantly, from 33 to 56. CEO Shin stated, “The Innovation Voucher program was instrumental in expanding our market and raising brand awareness by widely publicizing the efficacy of stem cell extraction, treatment, and procedures both domestically and internationally through online promotions.” “With growing interest in stem cells and their expanding applications, we needed public relations efforts.” Miracell’s sales target for this year is approximately 13 billion won. The company has expanded into approximately 10 new countries and increased exports to 2.5 billion won, more than doubling last year’s figure.Furthermore, the company plans to build a smart factory for production to secure competitiveness and accelerate growth.CEO Shin stated, “I hope the Innovation Voucher program will be a strong supporter of our smart factory construction. We will continue to work tirelessly to ensure that the synonym ‘stem cell = Miracell’ is recognized.” Reporter Kang Jae-woong, kjw@fnnews.com Source: https://www.fnnews.com/news/202408281338326211
“The effectiveness of bone marrow stem cell injections has been proven safe and effective using a system called SmartMcell.”
Knee arthritis, often called “a side effect of the blessing of longevity,” is a disease of the elderly that is rapidly increasing with the aging population.According to the Health Insurance Review and Assessment Service, 3,201,368 patients received treatment for knee joint disease last year.This represents a roughly 30% increase from 2,411,308 patients ten years ago. Sixty percent of patients are over the age of 65. Treatment for knee arthritis typically involves steroid injections, known as “bone injections,” which have anti-inflammatory properties and are effective in alleviating pain, or procedures involving endoscopic insertion into the joint.Recently, however, autologous bone marrow stem cell injections have been recognized for their cartilage regeneration properties, leading to a surge in the number of such procedures.We met with Dr. Kim Jin-gu, Director of Myongji Hospital, to learn about the effects and precautions of autologous bone marrow stem cell injections, as well as how to manage knee arthritis. Autologous bone marrow stem cell injections are less effective for those over 50. The Ministry of Health and Welfare has approved “autologous bone marrow stem cell injection” as a new medical technology. The correct name is “intra-articular bone marrow aspirate concentrate injection for knee osteoarthritis.” This treatment involves extracting bone marrow from the patient’s pelvis, centrifuging it, extracting and concentrating the stem cells, and then injecting them back into the knee to reduce inflammation and improve joint function. Compared to existing hyaluronic acid injections, it has been reported to provide similar pain relief and improved joint function. The Ministry’s designation as a new medical technology signifies a certain degree of recognition of its safety and efficacy. However, the medical evidence is still insufficient to clearly demonstrate its effectiveness, and more research is needed. The Ministry of Health and Welfare has indicated that autologous bone marrow stem cell injection is indicated for intermediate-stage knee arthritis.Medically, these conditions are categorized as follows: △ A joint space is clearly narrowed compared to normal on an X-ray or falls within the osteoarthritis grade (KL Grade 2-3); △ More than 50% cartilage damage is confirmed via magnetic resonance imaging (MRI) or arthroscopy; or △ Grade 3 or 4 according to the International Cartilage Regeneration Society (ICRS) grading system. Director Kim stated, “Even if these criteria are met, autologous bone marrow concentrates in patients over 50 years of age are not a fundamental solution because their cellular potency is significantly reduced.” “Even in cases of severe bowlegs, injected stem cells are quickly damaged, making satisfactory results unlikely.” Director Kim continued, “According to the Ministry of Health and Welfare’s New Medical Technology Evaluation Report, the efficacy of autologous bone marrow stem cell injections is not limited to the concentrate extracted from bone marrow, but rather to the use of a specific system.” “Since the safety and efficacy of bone marrow aspirate concentrate separated and concentrated using a system called Smart M-Cell have been recognized, it is necessary to verify whether the procedure was performed using that system.” Carefully review whether actual cost insurance coverage is applicable. The term “autologous bone marrow stem cell injection” often leads to the misconception that extracting and injecting one’s own stem cells can generate new cartilage and treat arthritis. Bone marrow extracted from the pelvis contains only about 7% of stem cells, and even when concentrated, there is insufficient evidence to support cartilage formation. Recently, some hospitals have been emphasizing the cartilage regeneration effects of stem cells, sparking controversy. The Ministry of Health and Welfare removed the phrase “concentrated bone marrow stem cells” from new medical technology approval documents and revised the term to “concentrated bone marrow aspirate.” Furthermore, failing to accurately assess one’s joint condition and whether or not to receive autologous bone marrow stem cell injections can lead to disappointment.According to the Financial Supervisory Service, a patient requiring artificial joint replacement surgery received injections out of fear of the surgery and filed an actual cost insurance claim. However, an X-ray revealed that the patient had Grade KL 4, a terminal form of knee arthritis, and the claim was denied.There have been cases where patients receiving autologous bone marrow stem cell injections into their shoulders were denied insurance coverage because the new medical technology was deemed to be limited to “knee treatment.” The Financial Supervisory Service recommends that hospitals verify eligibility for actual cost insurance before treatment, including by issuing documentation. Director Kim advised, “Autologous bone marrow stem cell injections require an accurate diagnosis through imaging tests such as MRI or weight-bearing X-rays before undergoing the procedure.” Choose an exercise method that fits your physical condition. Aging is the primary cause of knee joint damage. Lack of lower body muscle strength combined with obesity in the upper body or prolonged habits like cross-legged posture can strain the knee joint and worsen symptoms. Therefore, efforts to reduce joint strain and strengthen the muscles around the joints are crucial. Dr. Kim stated, “While walking is often cited as an easy exercise for middle-aged and older adults to incorporate into their daily lives, walking may be limited in its effectiveness in strengthening the muscles around the joints.” He emphasized, “A balanced diet, including aerobic exercise, strength training, balance training, intrinsic movement, sensory recovery exercises, and stretching, is essential for joint health and pain prevention.” He added, “Consult with a fitness professional to determine the right exercise program for you. If knee pain persists and muscle strength is weakened, a combination of five or six moderate-intensity to low-intensity exercises is recommended.” For example, to avoid straining your knee joints, you should walk 8,000 steps, then do 100 squats, climb 20 flights of stairs, and ride an exercise bike for 20 minutes, with ample rest breaks in between. The most important thing is to consistently practice these exercises every day. Lee Jin-han, Medical Reporter and Doctor, likeday@donga.com Source: Donga Ilbo https://www.donga.com/news/Health/article/all/20240723/126061373/2
Miracell Selected as a “Global Promising Company” by the Ministry of SMEs and Startups
Miracell selected as a “Global Promising Company” by the Ministry of SMEs and Startups… Possession of original technology for Smart Mcell stem cell extraction system Stem cell specialist Miracell announced on the 21st that it has been selected as a promising company for the “2024 Global 1,000+ Small and Medium Enterprises Project,” hosted by the Ministry of SMEs and Startups. This project is a national initiative that designates promising export SMEs that are entering the global market based on their technological prowess and innovation. This system selects SMEs with high growth potential among those with exports exceeding $100,000 in the previous year and provides preferential overseas marketing and financing support from export support agencies. For 2024, 473 companies were selected based on export volume, categorized into four categories: Global Promising, Growth, Strong, and Strong+. Miracell was recognized for its contribution to increased exports and national economic development through its stem cell extraction system, “SMART M-CELL” and BmSC kit. In November of last year, the Ministry of Trade, Industry and Energy designated Miracell a “Next Generation World-Class Product.” Following its designation as a promising global small and medium-sized enterprise by the Public Procurement Service (PPS), Miracell has been highly evaluated by the government for its potential to lead the global market. Founded in the medical industry in 1986, Miracell has been actively developing stem cell systems since 2007. It manufactures ready-to-use biological drugs, and has directly registered new medical technologies using autologous stem cells for acute myocardial infarction, critical limb ischemia, and cartilage defects. Furthermore, through clinical research with renowned professors at university hospitals, last year, it received approval for a new medical technology for its bone marrow stem cell injection treatment for knee osteoarthritis. Smart Mcell & BmSC is a biosystem capable of extracting large quantities of stem cells. It separates and concentrates stem cells, growth factors, and total cells from a patient’s blood and bone marrow. It boasts a cell viability rate of up to 99%. Smart M-Cell is a core therapeutic material in regenerative medicine, used in knee osteoarthritis treatment and anti-aging procedures at university hospitals and other hospitals nationwide. Miracell has consistently achieved export success by participating in conferences such as the American Academy of Orthopaedic Surgeons (AAOS), the European Society of Sports Traumatology, Knee and Arthroscopy (ESSKA), and the American Medical World Congress (AMWC) to promote Korea’s stem cell system. As a result, SMART M-CELL has been adopted and used in hospitals in Europe, as well as in other countries, including Sweden, Austria, Greece, Italy, and Turkey. Shin Hyun-soon, CEO of Miracell, stated, “Having been selected as a promising company in this global small and medium-sized enterprise project and given favorable conditions for exports, we will further dedicate ourselves to promoting Korea’s outstanding regenerative biosystem to the global market.” Reporter Lee Jeong-hee kunkang1983@naver.comSource: Health Digest (http://m.ikunkang.com/news/articleView.html?idxno=40018)
Miracell CGP Hospital in Greece also… High patient satisfaction with stem cell treatment.
Miracell CGP Hospital in Greece also… High patient satisfaction with stem cell treatment. Stem cell specialist Miracell Co., Ltd. held business meetings with overseas CGP hospitals using its “Smart M-Cell” stem cell extraction system.Miracell visited the Ilias Theodoropoulos Clinic in Greece, a CGP membership hospital, from January 16th to 17th to assess local demand, conduct follow-up services, and meet with buyers. The Cellpia Global Platform (CGP) is a medical membership operated by Miracell. It provides professional training, cell therapy technology transfer, and medical equipment setup to ensure safe stem cell regenerative medicine treatments. Dr. Ilias Theodoropoulos, a Greek hematologist and director of the Ilias Theodoropoulos Clinic “It’s been nearly a year since I started using Miracell’s stem cell system, Smart M-Cell, and I’ve already performed over 250 cases,” he said. “I primarily perform IV stem cell injections and pain management procedures, and most patients who have received the treatment are very satisfied with the regenerative medicine stem cell treatment.” A female patient in her 40s, who visited the hospital to check on her treatment progress, shared her experience in a video interview, saying that her rheumatoid arthritis improved after stem cell treatment. “I’m a musician who plays an instrument, and I was devastated by rheumatoid arthritis in my fingers. I was struggling to move my fingers properly, but after receiving stem cell treatment from Dr. Ilias Theodoropoulos at this hospital, my skeletal system was restored.” She continued, “After two stem cell treatments, my finger movements became freer, and my entire body became more flexible and youthful.I felt the changes taking place within my body after the stem cell injections. It felt like my cells were working harder and regaining their vitality. It was incredible, and it has enabled me to become a better musician.I’m grateful to Dr. Ilias.” He continued, “I had no side effects from the stem cell injections, my fatigue disappeared, and I gained a lot of strength and energy.” He added, “I am very satisfied with the results of the treatment using the Miracell device.” Meanwhile, Miracell shares cutting-edge stem cell treatment techniques with overseas CGP member hospitals and actively supports post-treatment care. [Edaily Reporter Lee Soon-yong] Source: Edaily (https://www.edaily.co.kr/news/read?newsId=02092646638786256&mediaCodeNo=257&OutLnkChk=Y)
[Press Release] Medical Expense Insurance Companies Conduct Comprehensive Investigation into Knee Bone Marrow Stem Cell Injection Costs
Medical expense insurance companies are conducting a full investigation into the cost of knee bone marrow stem cell injections. Equipment and materials used vary widely by hospital… On-site investigation underwayRecently, there has been a rise in cases of “knee stem cell injections” for various types of knee arthritis. Consequently, medical expense insurance companies are reportedly conducting a comprehensive investigation into the cost of knee bone marrow stem cell injections. The New Medical Technology Assessment Report on Intra-Articular Bone Marrow Aspirate Concentrate Injection for Knee Osteoarthritis (Ministry of Health and Welfare Notice No. 2023-128) specifies the procedure as “centrifuging autologous bone marrow from the patient’s iliac crest and injecting the concentrated ‘bone marrow stem cells’ into the knee joint.” According to the Ministry of Food and Drug Safety, “If a company intends to promote bone marrow stem cell therapy, it must submit supporting data regarding the isolation and identification of the relevant component (Article 29, Paragraph 1, Subparagraphs 2, 3, and 8 of the Regulations on Medical Device Approval, Reporting, and Review, etc.). Depending on the intended content, this data may include an equivalence evaluation with an already approved product or a standalone evaluation of the product being applied for.” The Ministry further states, “Depending on the intended content, clinical trial data may also be required.” While bone marrow stem cell injections are generally used for the treatment of patients with knee osteoarthritis, as per the Ministry of Health and Welfare’s notice, some hospitals and clinics are using bone marrow cell layers that have not been validated as stem cells or concentrating bone marrow in blood vessels. Therefore, patients should be cautious before undergoing the procedure. Orthopedic clinics and nursing hospitals nationwide have introduced bone marrow stem cell injections for knee osteoarthritis, and the number of patients receiving the treatment is increasing. Consequently, insurance companies are reportedly receiving a steady stream of claims for actual loss insurance. A physical damage adjuster from the long-term compensation support team of an insurance company said, “The claims amount varies from as little as 1 million won to as much as 16 million won, and there are many hospitals that have overcharged the amounts, so we have formed an investigation team and are conducting on-site inspections.” He added, “Since the equipment and treatment materials used by each hospital vary greatly, we are requiring that the manufacturing lot number and serial number be written on the name of the equipment used for bone marrow infusion. We are also requesting that hospitals attach a copy of the Ministry of Food and Drug Safety approval to show which stem cell extraction system was used for the treatment and whether a stem cell-approved product was used.” Reporter Lee Jeong-hee kunkang1983@naver.com Source: Health Digest (http://www.ikunkang.com/news/articleView.html?idxno=39228)
Holimer, our Türkiye Miracell partner, launched a MIRACELL Stem Cell Gala Dinner seminar in November
Holimer, our Türkiye Miracell partner, launched a MIRACELL Stem Cell Gala Dinner seminar in November Holimer, our Türkiye Miracell partner, launched a MIRACELL Stem Cell Gala Dinner seminar in November 2023. Several doctors including OS specialists, attended the gala dinner hosted by Holimer last month of November in the Antalya region of Türkiye to expand the awareness and at the same time to promote the benefits of stem cells treatments. Several doctors including OS specialists, attended the gala dinner hosted by Holimerlast month of November in the Antalya region of Türkiye to expand the awareness and at the same timeto promote the benefits of stem cells treatments. https://www.youtube.com/watch?v=pr8_QH2T0aI List
Knee Bone Marrow Stem Cell Injections: Effective Only Through a Proven System
[Expert Column] Knee Bone Marrow Stem Cell Injections: Require a Proven System for Effectiveness Concerns about patient harm from unlicensed bone marrow cell extractors. Government approval of new medical technology is needed. Age is the strongest risk factor for knee osteoarthritis. Pain worsens during activity and at night, and symptoms such as morning stiffness, instability, and decreased function cause discomfort in daily life. Despite the high prevalence of knee osteoarthritis in Korea, treatment has focused solely on pain relief rather than addressing the underlying cause of the disease. With the recent increase in interest in regenerative medicine, various treatment methods are being explored for arthritis, one of which is bone marrow stem cell injections.Bone marrow stem cells not only alleviate pain in arthritis patients, but also, through the action of various chemical messengers (cytokines) and growth factors found in bone marrow,reduce joint cell destruction and protect existing joint cells. They are also known to play a role in altering the progression of the disease by promoting the regeneration of certain joint cells.In July, after reviewing various data, the government announced that intra-articular injection of bone marrow aspirate concentrate (Ministry of Health and Welfare Notice No. 2023-128) for knee osteoarthritis was a valid treatment method, a “new medical technology.” The “knee bone marrow stem cell injection,” which received this new medical technology designation, has been a safe procedure used in the United States for the treatment of knee arthritis patients for over a decade. Many hospitals and clinics across the country are competitively introducing “bone marrow stem cell injection,” but the government’s notice lacks clear guidelines regarding the procedure. According to the Ministry of Health and Welfare’s New Medical Technology Assessment Report, the procedure involves “centrifuging autologous bone marrow collected from the patient’s iliac crest and injecting the concentrated bone marrow stem cells into the knee joint.” However, the various devices currently in use for collecting and concentrating bone marrow concentrates can vary in their composition, making it uncertain whether they are sufficiently effective in treating arthritis. Effective arthritis treatment requires a sufficient number of stem cells, a sufficient amount of chemical messengers (cytokines), and growth factors. Therefore, using bone marrow concentrates using proven devices can maximize the effectiveness of these treatments. Furthermore, according to the paper used as a reference for this new medical technology clinical trial (Comparison of the Effects of Intra-articular Injections of Bone Marrow Stem Cells (BMAC) and Autologous Serum (ACS) in Patients with Early-Stage Knee Osteoarthritis, Italy, 2022), “Effective treatment results were achieved by extracting 60 cc of the patient’s bone marrow, concentrating it using SmartPrep (a stem cell concentrator), and injecting 7-10 cc of stem cells into the knee joint cavity.” Therefore, precise injection dosage is crucial. The Ministry of Health and Welfare should clearly state the use of “bone marrow stem cells” in autologous bone marrow stem cell injections, and provide guidance on how to accurately quantify the amount of stem cells used. Furthermore, it’s necessary to verify that devices that haven’t been validated as stem cells (and haven’t undergone equivalence evaluations) are being used indiscriminately to treat patients with knee osteoarthritis, as outlined in the treatment material approval documents. Meanwhile, a medical expense insurance representative at an insurance company stated, “Patients with knee osteoarthritis with ICRS grades 3-4 and KL grades 2-3 are eligible for actual cost medical insurance. However, we are requesting additional information from the manufacturer regarding the stem cell extraction system used, including the equipment lot number and a list of hospitals that used the device.” The insurance industry stated, “The insurance industry doesn’t cover all knee stem cell injections. We conduct thorough reviews based on the information (use of bone marrow stem cells) specified in the new medical technology treatment method.” This indicates that stem cell treatment will be strictly enforced. Stem cell therapy, a national project in South Korea, requires caution as some hospitals are using unverified devices to treat patients with bone marrow concentrates. This practice should not be ignored by patients seeking the now-approved treatment for arthritis using autologous bone marrow concentrates. Kim Myeong-gu, Director of the Orthopedic Surgery Center at Incheon Paik Hospital and former President of the Korean Orthopedic Association
Miracell’s Stem Cell Extraction System, “Smart M-Cell,” Selected as a “Next-Generation World-Class Product” by the Ministry of Trade, Industry and Energy
Smart Mcell selected as a “next-generation world-class product” by the Ministry of Trade, Industry and Energy. Recognized for its advanced technology and competitiveness, Miracell has significantly contributed to export growth and national economic development.It is currently being used in knee osteoarthritis treatment and anti-aging procedures at hospitals and clinics nationwide, including university hospitals.[Bio Times] Stem cell specialist Miracell (CEO Shin Hyun-soon and Shin Nuri) announced on November 10th that its stem cell extraction system, “SMART M-CELL,” was selected as a next-generation world-class product at the “2023 World-Class Product Certification Ceremony,” held on November 9th at the Grand Ballroom of the Grand Intercontinental Hotel in Seoul. Hosted by the Ministry of Trade, Industry and Energy (Minister Bang Moon-kyu) and organized by the Korea Trade-Investment Promotion Agency (KOTRA), the ceremony, now in its 23rd year, was attended by approximately 150 representatives from relevant organizations and selected companies. World-class product and manufacturing company certifications were awarded to 73 products and 78 companies. “Next-Generation World-Class Products” are products with high potential to lead the global market in the future. Miracell’s cell centrifuge, “Smart M-Cell,” has been recognized for its advanced technology and competitiveness, contributing significantly to export growth and national economic development. Miracell was selected as a 2023 Next-Generation World-Class Product and received a certificate from the Minister of Trade, Industry and Energy. Miracell’s Smart M-Cell is a bio-device capable of extracting large quantities of stem cells. It separates and concentrates stem cells, growth factors, and total cells involved in regeneration from a patient’s blood and bone marrow. Approved by the National Health Technology NET and the FDA, Smart M-Cell boasts a cell viability rate of up to 99% and is used in hospitals and clinics nationwide, including university hospitals, for the treatment of knee osteoarthritis and anti-aging procedures. Miracell CEO Shin Hyun-soon stated, “Following the direct listing of our bone marrow stem cell injection as a new medical technology for knee osteoarthritis, we are very pleased that the government has recognized Smart Mcell’s technological prowess with this World-Class Product designation. As a leader in regenerative medicine stem cell treatment, we will further expand our exports to the global market and achieve recognition as a world-class product on the global stage.” Meanwhile, Miracell is exporting its stem cell systems to countries around the world, including Italy, Austria, Greece, and Dubai. The company also plans to expand its presence in the European market by participating in MEDICA 2023, the world’s largest medical device exhibition, held in Düsseldorf, Germany, from November 13th to 16th. [Biotimes = Reporter Jeong Min-a] news@biotimes.co.kr Source: BioTimes (http://www.biotimes.co.kr)
Confirmation Needed: Whether Bone Marrow Stem Cell Injections for Knee Osteoarthritis Have Received Government Approval as a New Medical Technology
It is necessary to confirm whether bone marrow stem cell injections for the treatment of knee arthritis have been approved as a new medical technology by the government. Concerns about patient harm from unlicensed bone marrow cell extractors. Government approval of new medical technology is needed. [Medical Newspaper/Daily Newspaper = Reporter Lee Sang-man] The Ministry of Health and Welfare recognized “bone marrow stem cell injection,” which uses cells extracted from the bone marrow of patients with osteoarthritis of the knee and directly injects them into damaged knees to safely promote cartilage regeneration, protect, and treat the condition, as a new medical technology in July. Smart Mcell + Bone Marrow Kit BMSC, approved as a stem cell Patients with knee arthritis can receive medical benefits through actual cost insurance if they meet the eligibility criteria for bone marrow stem cell injection therapy. However, it’s important to note that not all stem cell treatments are created equal. First, it’s important to note that the stem cell injections listed as a new medical technology by the Ministry of Health and Welfare are derived from bone marrow, not fat. Confirmation of whether the injection is a bone marrow stem cell injection is necessary, followed by the biosystem and dedicated kit for stem cell extraction. It’s crucial to verify that the devices and kits used in clinical trials of this new medical technology are indeed used. Using a kit that doesn’t specifically mention stem cells or that doesn’t comply with the approved specifications is incompatible with bone marrow stem cell therapy, which is recognized as a new medical technology. An official from the legal team of Miracell, which directly applied for registration of this new medical technology and manufactured the Smart M-Cell and bone marrow kit used in clinical trials, explained, “First of all, stem cells used to treat patients with knee osteoarthritis must be listed as ‘bone marrow stem cells’ in the MFDS approval. To do this, they must undergo an equivalence evaluation with a previously approved device as specified in the Regulations on Approval, Reporting, and Review of Medical Devices (MFDS Notice No. 2023-39, Article 3, Paragraph 11).” He continued, “The Ministry of Food and Drug Safety (MFDS) determines approval through a process that verifies the intended use, operating principle, raw materials, performance, testing specifications, and method of use of a medical device that has already been approved and certified. The problem is that stem cell extraction systems and kits from companies that do not meet these criteria are being indiscriminately used to treat patients with knee osteoarthritis.” He continued, “Recently, some hospitals are using kits that are identical to blood kits, but with only a bone marrow acupuncture needle attached. These kits cost between 300,000 and 500,000 won. Kit models that have not been used in clinical trials for new medical technologies have not been proven to have a viability and recovery rate for cells, which is crucial for stem cell therapy. This could render the procedure unrelated to stem cells.” Bone marrow stem cell injections for knee arthritis are listed as new medical technologies and are therefore eligible for non-coverage insurance benefits. However, there has been controversy recently over a medical institution that has been charging high fees for procedures using unproven stem cell extraction devices and kits, claiming they have advanced equipment and hospitalization facilities. Meanwhile, an official from B Insurance Company expressed concern, saying, “In accordance with the ‘Revised Best Practices for Insurance Fraud Prevention’ announced by the Financial Supervisory Service in April of last year, we are tightening our insurance claim review standards to prevent excessive treatment for non-covered items. However, if the number of hospitals and clinics abusing the new medical technology of bone marrow stem cell injections for knee arthritis to incur excessive claims increases, they will become targets for the insurance industry and this could negatively impact patient claims payments.” Source: Medical Newspaper (http://www.bosa.co.kr/)
Bone Marrow Stem Cell Injections for Knee Arthritis Approved as New Medical Technology
Bone marrow stem cell injections for knee arthritis patients approved as a new medical technology. Miracell’s Smart M-Cell and dedicated kit treatment recognized as safe and effectiveProfessor Chae Dong-sik, Department of Orthopedic Surgery, Catholic Kwandong University International St. Mary’s Hospital, based on clinical research and literatureBone marrow stem cell injections for patients with knee osteoarthritis have been recognized as a new medical technology. The Ministry of Health and Welfare recognized “Intra-articular Injection of Bone Marrow Aspirate Concentrate in Patients with Knee Osteoarthritis” (Ministry of Health and Welfare Notice No. 2023-128, July 11, 2023), applied for by stem cell company Miracell, as a new medical technology. On July 11th, the Ministry announced partial revisions to the “Notice on the Results of the Safety and Efficacy Evaluation of New Medical Technologies” and the “Notice on New Medical Technologies Suspended from Evaluation.” Miracell applied for registration as a new medical technology in November of last year for its bone marrow stem cell treatment for osteoarthritis using its stem cell extraction system, SMART M-CELL, and a dedicated kit, based on clinical research and literature review by Professor Chae Dong-sik of the Department of Orthopedics at International St. Mary’s Hospital. The company announced on the 16th that the New Medical Technology Assessment Committee (May 26, 2023) determined that the technology was safe and effective in alleviating knee joint pain and improving function. Smart M-Cell is an advanced regenerative biosystem capable of selectively isolating, automatically extracting, and concentrating stem cells. It boasts a cell viability rate of up to 99% and provides cells optimized for tissue regeneration and core cells that are a rich source of protein, supporting effective cell therapy. This new medical technology is intended for patients with knee osteoarthritis with International Cartilage Regulation & Joint Preservation Society (ICRS) grades 3-4 or Kellgren-Lawrence (KL) grades 2-3. The procedure involves harvesting autologous bone marrow from the patient’s iliac crest, centrifuging it, and injecting the concentrated bone marrow stem cells into the knee joint (intra-articular injection of bone marrow aspirate concentrate for knee osteoarthritis). As a result of the safety and efficacy evaluation, no serious complications or adverse effects were reported in the reviewed literature for intra-articular injection of bone marrow aspirate concentrate in patients with knee osteoarthritis. Reported adverse events were mild, demonstrating its safety. Compared to existing injection treatments (such as intra-articular injections using hyaluronic acid), intra-articular injection of bone marrow aspirate concentrate demonstrated similar pain relief and improved joint function, demonstrating its effectiveness. Thus, intra-articular injection of bone marrow aspirate concentrate in patients with knee osteoarthritis has been recognized as a safe and effective technique for relieving knee joint pain and improving function, allowing its clinical use. Meanwhile, Miracell has been focusing on stem cell research and development since 2007, and in 2012, it was the only company to receive a new medical technology designation for its autologous bone marrow stem cell treatment for cartilage defect patients. Following this, Miracell directly registered its treatments for critical limb ischemia (2013) and acute myocardial infarction (2014) as new medical technologies, receiving certification from the Ministry of Food and Drug Safety and the Ministry of Health and Welfare. In February 2021, Miracell received NET (New Health Technology) certification for its “Smart M-Cell,” which selectively isolates and concentrates stem cells from blood and bone marrow, and extracts large quantities. Following its selection as a government-designated innovative company, Miracell was also selected as an innovative product by the Public Procurement Service in May 2021. Miracell has secured its source technology for stem cells through 21 domestic and international cell extraction technology patents. Having completed US FDA registration, it is committed to advancing advanced stem cell treatment and regenerative medicine. By Lee Byeong-mun, Medical Specialist Source: Maeil Business Newspaper (http://www.mkhealth.co.kr)