Cell therapy is one of the categories of regenerative medicine. In Taiwan, thanks to the efforts of professionals, public and private groups, government agencies and administrative departments over the years, the Legislative Yuan passed the “Regenerative Medicine Act” and the “Regenerative Medicine Preparations Management Act” on June 4, 2024, hoping to benefit more patients while ensuring the safety, quality and efficacy of regenerative medicine.
Chen Changyi, Medical Affairs Manager, Biyi Biotech
The Development History of Cell Therapy in Taiwan
In June 2015, the internationally shocking Formosa Fun Coast dust storm occurred. At the time, a large number of patients with extensive burns required emergency treatment and assistance. With the assistance of Japanese cell therapy technology, some patients benefited from the use of autologous artificial skin grafts, achieving good treatment results. This also made Taiwan aware of the development prospects and importance of cell therapy. In September 2018, the Ministry of Health and Welfare issued amended provisions of the “Regulations Governing the Implementation or Use of Specific Medical Technologies, Examinations, Tests, and Medical Instruments,” referred to as the “Special Regulations.” This law allows six cell therapy technologies to be clinically applied in approved medical institutions before clinical trials are fully completed, but must meet strict conditions, such as patient informed consent and monitoring of treatment effects. These technologies include autologous immune cells, autologous adipose stem cells, autologous bone marrow mesenchymal stem cells, autologous fibroblasts, and autologous chondrocytes. Meanwhile, the Ministry of Health and Welfare also began preparing the “Regenerative Medicine Act.” In 2023, it proposed two draft bills: the “Regenerative Medicine Act” and the “Regenerative Medicine Preparations Management Act.” These two draft bills adopt a dual-track system to regulate both medical technologies and products. They were passed by the Legislative Yuan on June 4, 2024, and implemented by presidential proclamation on June 19 of the same month. The implementation of these two laws reflects the Taiwanese government’s high regard for patient safety and technical standards, ensuring the safety and quality of regenerative medicine performed by medical institutions, and more importantly, protecting patients’ rights to receive related treatments.
Current Status of Cell Therapy Development in Taiwan
With the rapid development of cell therapy technology and increasing medical needs, the number of related applications has been increasing year by year, including clinical trial applications and formal application licenses for treatment technologies. The application cases for the five major application technologies are summarized below (statistics as of June 30, 2024):
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Autologous immune cell therapy: The indications for application are hematologic malignancies that have not responded to standard treatment, stage I to III solid cancers that have not responded to standard treatment, and stage IV solid cancers. There are 329 applications, 252 of which have been approved for implementation, and 1296 cases have been received.
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Autologous fat stem cell therapy: The indications for its application are osteoarthritis and knee cartilage defects and chronic or difficult wounds that have not healed for more than six weeks. There have been 126 applications, 77 of which have been approved for implementation, and 153 patients have been admitted.
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Autologous fibroblast therapy: The indications for its application are skin defects: filling and repairing wrinkles, pits and scars. There are 17 applications, 14 of which have been approved for implementation, and 10 cases have been accepted.
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Autologous bone marrow mesenchymal stem cell therapy: The indications for application are spinal cord injury, osteoarthritis and knee cartilage defects. There are 33 applications, 27 of which have been approved for implementation, and 84 cases have been accepted.
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Autologous chondrocyte therapy: The indication for application is knee joint cartilage defects. There are 12 applications, 11 of which have been approved for implementation, and 64 cases have been accepted.
Currently, the regenerative medicine agents approved for use in Taiwan include:
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Kymriah Intravenous Suspension: A CAR-T therapy used to treat acute lymphoblastic leukemia, diffuse large B-cell lymphoma, and follicular lymphoma.
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Zolgensma (Zolgensma Intravenous Suspension): A gene therapy agent used to treat spinal muscular atrophy.
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Luxturna (injection): A gene therapy agent used to treat Leber congenital amaurosis, a rare hereditary retinal membrane disease.
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Novartis Luxturna: A gene therapy agent used to treat hereditary retinal malnutrition that is not Leber congenital amaurosis.
Taiwan has established a comprehensive regulatory framework to support the development and application of cell therapy technology, based on the dual laws governing regenerative medicine and special regulations. This framework clearly defines the application process for technology and standardizes the safety and efficacy verification of clinical applications, driving the participation of numerous medical institutions and industries and promoting overall development. Despite the rapid development of cell therapy in Taiwan, many challenges remain, such as technology standardization, high treatment costs, patient accessibility, and medical acceptance. Addressing these challenges, improving usability, and gaining international recognition are crucial for the future development of cell therapy in Taiwan. Overall, with regulatory support and active industry participation, cell therapy and regenerative medicine in Taiwan possess considerable potential, and further technological breakthroughs and expanded clinical applications are expected in the future.
