Traditional drug treatments have largely relied on small-molecule chemical compounds, designed based on predictable mechanisms of action and metabolic rates to achieve therapeutic effects.
As a result, cell therapy has gradually gained prominence, and in recent years, many successful clinical applications have demonstrated its transformative potential.
Bryant Chen, Medical Affairs Manager, Beyond BioMedical Inc.
In simple terms, cell therapy involves the use of a patient’s own cells (autologous) or donor-derived cells (allogeneic), which undergo a series of processing and modifications before being reintroduced into the patient’s body to achieve specific therapeutic effects.
The scope of application is extensive — covering cancer, autoimmune disorders, neurodegenerative diseases, and genetic disorders.
As an independent medical discipline, the concept of cell-based therapy can be traced back to the 1960s, with several landmark breakthroughs shaping its evolution.
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In 1959, Dr. E. Donnall Thomas successfully performed the first bone marrow stem cell transplantation in a leukemia patient. This breakthrough demonstrated the therapeutic potential of stem cells, and in the decades that followed, bone marrow transplantation became an important means of treating various blood-related diseases.
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In the 1980s, scientists discovered the existence of hematopoietic stem cells in umbilical cord blood and performed the first umbilical cord blood transplant in 1988.
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In 1981, Dr. Sir Martin Evans successfully isolated mouse embryonic stem cells, laying the foundation for later cell therapy. He was awarded the Nobel Prize in Physiology or Medicine in 2007.
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In 1990, Dr. Steven A. Rosenberg conducted the first clinical trial of gene therapy in the United States, marking the beginning of this field.
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In the 2000s, embryonic stem cell research became a focus of scientific and ethical discussions. In particular, in 2006, Japanese stem cell scientist Shinya Yamanaka discovered that four transcription factors could convert mouse skin fibroblasts into induced pluripotent stem cells (iPS). This technology not only allowed scientists to begin inducing stem cells from somatic cells, but also promoted the development of regenerative medicine and cell therapy.
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With the maturation of technology and rapid progress in clinical trials, cell therapy has seen more clinical applications since 2010. Among these, the most well-known is CAR-T therapy, which utilizes chimeric antigen receptor T cells. This therapy combines genetic, cellular, and immune characteristics to achieve personalized treatment. In 2017, the US FDA also approved CAR-T therapy for the first time for the treatment of childhood and adolescents with B-cell acute lymphoblastic leukemia and malignant lymphoma, indicating that more cell therapy products will be approved and put into clinical use in the future, showing great potential in treating a variety of diseases.
Cell therapy can be broadly categorized into two types based on its application: “cancer immunotherapy” and “tissue regenerative medicine.” Furthermore, based on different treatment principles and objectives, many different therapies have emerged. Taiwan’s Ministry of Health and Welfare began preparing for the “Regenerative Medicine Act” as early as 2018, and successfully passed the legislation in June 2024 after its third reading in the Legislative Yuan. The next article will provide a further explanation of cell therapy and its current implementation in Taiwan.
For further inquiries, please contact: Bryant.chen@be.tworg.app
