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【Medical Insights】The Future and Development of Cell Therapy

Since the official release of the "Specific Medical Technology Inspection and Testing Medical Instrument Implementation or Use Management Measures" (hereinafter referred to as the "Specific Measures") by the Ministry of Health and Welfare in September 2018, autologous cell therapy has been opened up in Taiwan. As a result, many biotech companies in Taiwan have actively invested in the research and development of cell therapy. Following this, in August 2021, the Ministry of Health and Welfare drafted the "Regenerative Medicine Development Act," incorporating the "Specific Measures" and the "Regenerative Medical Product Management Regulations." The draft of the "Regenerative Medicine Three Laws" was announced in January of this year (2022), indicating the active promotion of the development of the cell therapy industry by the Ministry of Health and Welfare. The expected regulatory relaxation will expand the application scope from originally restricting cell sources to only "human" cells, allowing for "heterologous" and "gene cell derivatives," making the application range more extensive.

Cell therapy refers to the use of human cell tissues, which involves extracting T cells, stem cells, etc., from one's own cells ("autologous" cells) or someone else's cells ("allogeneic" cells). After proliferation or processing through in vitro culture, these cells are reintroduced into the patient's body for treatment, aiming to rebuild the human structure, function, or treat diseases, with the goal of achieving the purpose of treating or preventing specific diseases.

Among cell therapies, the most mature and widely applied one in domestic and international research is cytokine-induced killer (CIK) cell therapy. It exhibits potent anti-tumor activity and a broad-spectrum effect, actively recognizing tumor cells, releasing factors that inhibit the growth of tumor cells, regulating the immune system, and indirectly killing tumor cells. CIK therapy is often used as adjuvant treatment for patients after surgery or radiochemotherapy.