Tag: wellness
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Trends of Gene Therapy Clinical Trials
Ting-En HuangSchool of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan Introduction Q1 2026 marked a slower period for regulatory approvals across gene, cell, and RNA therapies, alongside a growing emphasis on evidence-based development and de-risking. As of 2026 Q1, 40 gene therapies, 37 RNA therapies, and 75 non-genetically modified cell therapies had received…
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From Pluripotency to Patients: Current Progress in iPSC-Based Clinical Trials
Pei-Ru Jhuang Ph.D.(c) & Tzu-Tang Wei Ph.D.Department and Graduate Institute of Pharmacology, College of Medicine, National Taiwan University, Taipei, Taiwan Introduction Induced pluripotent stem cells (iPSCs) were first generated from mouse cells in 2006 and human cells in 2007 by reprogramming differentiated somatic cells back to a pluripotent state [1, 2]. Because iPSCs can proliferate…
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AMCHEPRY®: The First iPSC-Derived Cell Therapy Marks a New Era of Regenerative Medicine for Parkinson’s Disease
Tzu-Yu Chen & Thai-Yen Ling, Ph.D.Department and Graduate Institute of Pharmacology, College of Medicine, National Taiwan University, Taipei, Taiwan Introduction Since the development of induced pluripotent stem cell (iPSC) technology by Yamanaka and colleagues in 2006, regenerative medicine has undergone a remarkable transformation. Unlike embryonic stem cells, iPSCs are generated by reprogramming adult somatic cells…
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China’s CAR-T and Immune Cell Therapy CDMO Landscape: Process Development, GMP Manufacturing, and Platform-Based Global Expansion
Yung-Che Kuo, Ph.D.TMU Research Center for Cell Therapy and Regeneration Medicine,Taipei Medical University, Taipei, Taiwan CDMO Process Development for CAR-T and Other Immune Cell Therapy Products As chimeric antigen receptor T cell (CAR-T), universal CAR-T (UCAR-T), CAR-natural killer (CAR-NK), T cell receptor-engineered T cell (TCR-T), tumor-infiltrating lymphocyte (TIL), and other immune cell therapy products progressively…
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Beginning with the End in Mind, the Journey of Mesenchymal Stem/stromal Cell Therapy Product Development
Ching-Huai Ko1, Feng-Cheng Chou2 & Ling-Mei Wang31 President and CEO, Steminent Biotherapeutics Inc.2 Senior manager, Business development division, Steminent Biotherapeutics Inc.3 Chairperson and Chief Strategy Officer, Steminent Biotherapeutics Inc. Abstract Background: Cell therapy products are living drugs that serve as alternative therapeutic strategies for various unmet medical needs, including cancers, tissue degeneration, and immune dysregulations. To achieve global success,…
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ELIXCYTE® (Allogeneic Mesenchymal Stem Cell): An Integrated Translational Framework Supporting Clinical Development, Mechanism of Action, and Potency Assessment
Chi-Jung Liang#, Yi-Ting Chen#, Ting-Wang, Sih-Ting Lin, Yi-Pei Hung*UnicoCell Biomed Co., Ltd., Taipei, Taiwan Abstract Osteoarthritis (OA) and chronic kidney disease (CKD) are major chronic degenerative diseases representing significant unmet medical needs. Developed by UnicoCell Biomed, ELIXCYTE® is an allogeneic adipose-derived stem cell (ADSC) product currently in advanced clinical development, having completed Phase III enrollment for…
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CD19 and BCMA CAR-T Cell Therapy: A New Era in Autoimmune Disease Treatment
Vijetha Karen Kitchley, M.Sc.Editorial Office, The ACTO TimesInternational PhD Program in Cell Therapy & Regenerative Medicine, Taipei Medical University, Taipei, Taiwan Introduction Autoimmune disorders arise when immune tolerance breaks down, leading the immune system to mistakenly recognize self-tissues as foreign. These conditions collectively affect roughly 5–10% of individuals worldwide and include diseases such as systemic…
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From First Responders to Tumor Accomplices: The Plasticity of Neutrophils in Cancer
D. Renovaldi, M.Sc.Editorial Office, The ACTO TimesInternational PhD Program in Medicine, Taipei Medical University, Taipei, Taiwan Abstract Neutrophils are traditionally portrayed as short-lived innate immune cells that rapidly migrate to sites of infection or tissue injury. Cancer, however, can appropriate these emergency-response programs for its own benefit. Tumor-derived signals alter granulopoiesis, neutrophil maturation, trafficking, lifespan, and…
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Reimagining Cancer Treatment: The 2026 Tang Prize Laureates in Biopharmaceutical Science
The ACTO Times, Editorial Office The 2026 Tang Prize in Biopharmaceutical Science has been awarded jointly to Steven A. Rosenberg, Michel Sadelain, and Carl H. June for their groundbreaking contributions to the development of cellular immunotherapy, a revolutionary approach that enables a patient’s own immune system to recognize and destroy cancer [1,2]. Established in Taiwan in…
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South Korea’s Regulatory Architecture for Cell and Gene Therapies: Linking Clinical Research, Regulated Treatment, and Product Authorization
The ACTO Times, Editorial Office Abstract South Korea has established a distinctive regulatory architecture for cell and gene therapies that links advanced regenerative medicine, institution-based clinical research, medicinal-product development, and long-term safety oversight. The central framework was introduced through the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products,…
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