Cell · 2024
Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient.
Клиническое исследование I фазыСтатьяНазвание и аннотация: Перевод в очереди
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Wang Shusen, Du Yuanyuan, Zhang Boya, Meng Gaofan, Liu Zewen, Liew Soon Yi, Liang Rui, Zhang Zhengyuan, Cai Xiangheng, Wu Shuangshuang, Gao Wei, Zhuang Dewei, Zou Jiaqi, Huang Hui, Wang Mingyang, Wang Xiaofeng, Wang Xuelian, Liang Ting, Liu Tengli, Gu Jiabin, Liu Na, Wei Yanling, Ding Xuejie, Pu Yue, Zhan Yixiang, Luo Yu, Sun Peng, Xie Shuangshuang, Yang Jiuxia, Weng Yiqi, Zhou Chunlei, Wang Zhenglu, Wang Shuang, Deng Hongkui, Shen Zhongyang
Аннотация
We report the 1-year results from one patient as the preliminary analysis of a first-in-human phase I clinical trial (ChiCTR2300072200) assessing the feasibility of autologous transplantation of chemically induced pluripotent stem-cell-derived islets (CiPSC islets) beneath the abdominal anterior rectus sheath for type 1 diabetes treatment. The patient achieved sustained insulin independence starting 75 days post-transplantation. The patient's time-in-target glycemic range increased from a baseline value of 43.18% to 96.21% by month 4 post-transplantation, accompanied by a decrease in glycated hemoglobin, an indicator of long-term systemic glucose levels at a non-diabetic level. Thereafter, the patient presented a state of stable glycemic control, with time-in-target glycemic range at >98% and glycated hemoglobin at around 5%. At 1 year, the clinical data met all study endpoints with no indication of transplant-related abnormalities. Promising results from this patient suggest that further clinical studies assessing CiPSC-islet transplantation in type 1 diabetes are warranted.