Smart M-Cell (Miracell)
Stem
Cell Processing System
STEM CELL PROCESSING SYSTEMMIRACELL SMART M-CELLStem cell technology firm Miracell has secured clearance from the US Food and Drug Administration for its integrated cell-processing system, marking a significant milestone in the company's efforts to expand its presence in the global regenerative medicine market.The FDA approved the system comprising the Smart M-Cell cell concentration device, the BSC blood kit and the BmSC bone marrow kit in April.This FDA clearance comes as Smart M-Cell demonstrated equivalence to “SmartPReP,” a global standard device developed by the Immune Disease Institute at Harvard Medical School. Through this, the company earned international recognition for its technological sophistication and the quality of its cell extraction process.Stem cells are used in various clinical fields such as knee osteoarthritis, skin regeneration and antiaging therapies. In particular, autologous stem cell therapy utilizes cells extracted directly from the patient’s own blood, making it a safe option without the risk of immune rejection or cell mutation.Miracell has focused on standardizing the entire cell extraction process across collection, separation, concentration, recovery, and injection. The latest FDA clearance combines cell extraction equipment and a designated kit as a singular system, providing a base for collecting cells of consistent quality.Unlike conventional centrifuges, the Smart M-Cell is designed to separate and concentrate various effective cells, including stem cells, from blood and bone marrow. By minimizing physical impact on the cell, it focuses on obtaining a highly concentrated “total cell” while preserving its natural, inherent functions.The Smart M-Cell is used in over 700 medical institutions in Korea and exported to approximately 40 territories, including in Europe. Recently, medical professionals from Spain, Serbia and Greece drew attention by presenting clinical cases using Smart M-Cell at a European medical conference, with related papers in preparation.In Korea, researchers at Severance Hospital published a study in the SCIE-level international journal Molecular Neurobiology on the treatment of severe Alzheimer’s disease using autologous stem cells extracted with Smart M-Cell.The research team reported positive changes in the treatment group using Smart M-Cell, which includes enhanced memory and cognitive functions, a reduction in amyloid proteins — a key hallmark of Alzheimer’s disease — and increased brain metabolism.Miracell plans to expand the application of its stem-cell treatment technologies to various intractable diseases.
