The Legislative Yuan recently passed the Regenerative Medicine Act, transitioning the management of cell therapy from the special regulations to the new law. Chang Gung Memorial Hospital reported that by the end of 2023, it had approved nine special regulation projects, enrolling 210 cases, which accounts for 15% of the 1,398 cases nationwide under the special regulations. The hospital has independently established a GTP laboratory and six PIC/S GMP compliant cleanrooms for various immune cell and regenerative medicine cell processing clinical trials, rather than collaborating with biotech company labs.
The Ministry of Health and Welfare issued the "Special Regulations" on September 6, 2018, opening six cell therapy techniques to practice. To date, 56 medical institutions across Taiwan have been approved to execute cell therapy plans. There are 32 cell preparation facilities that have obtained GTP certification, including 29 biotech companies and only three medical institutions, with Chang Gung Memorial Hospital's Cell Therapy Center being one of them.
Chang Gung Memorial Hospital has been authorized under the special regulations to treat various conditions, including autologous dendritic cell (DC) therapy for liver cancer and gliomas, autologous adipose-derived stem cells for knee joint defects, autologous immune cells (CIK) for hematologic malignancies and solid tumors, and autologous bone marrow mesenchymal stem cell transplantation for spinal cord injuries.
Dr. Wei-Chen Lee, Deputy Superintendent of Linkou Chang Gung Memorial Hospital, noted that the hospital has long engaged in autologous dendritic cell therapy for liver cancer, treating 110 patients with 480 doses to date. The therapy has achieved a 70-80% disease control rate, with tumors not growing and remaining stable. The team is currently focusing on "cancer vaccine" research, using autologous dendritic cell therapy post-surgery to prevent cancer recurrence.
Chang Gung Memorial Hospital emphasized its internal development of a team of 19 professional cell processing technicians, quality control specialists, and coordinators. This team manages the entire process from patient consultation, infusion, and treatment follow-up to process development and quality control. As of now, the Chang Gung system has 14 cell therapy cases under review by the Ministry of Health and Welfare. In the future, it aims to offer 23 treatment options for cancer patients through immune cell therapy.
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