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)