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. 2024 Sep 20:S0092-8674(24)01022-5.
doi: 10.1016/j.cell.2024.09.004. Online ahead of print.

Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient

Shusen Wang  1 , Yuanyuan Du  2 , Boya Zhang  3 , Gaofan Meng  2 , Zewen Liu  3 , Soon Yi Liew  2 , Rui Liang  3 , Zhengyuan Zhang  4 , Xiangheng Cai  3 , Shuangshuang Wu  5 , Wei Gao  3 , Dewei Zhuang  5 , Jiaqi Zou  3 , Hui Huang  5 , Mingyang Wang  6 , Xiaofeng Wang  5 , Xuelian Wang  3 , Ting Liang  5 , Tengli Liu  3 , Jiabin Gu  5 , Na Liu  3 , Yanling Wei  5 , Xuejie Ding  3 , Yue Pu  5 , Yixiang Zhan  3 , Yu Luo  5 , Peng Sun  3 , Shuangshuang Xie  7 , Jiuxia Yang  3 , Yiqi Weng  8 , Chunlei Zhou  9 , Zhenglu Wang  3 , Shuang Wang  10 , Hongkui Deng  11 , Zhongyang Shen  12
Affiliations

Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient

Shusen Wang et al. Cell. .

Abstract

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.

Keywords: abdominal anterior rectus sheath; cell therapy; chemical reprogramming; chemically induced pluripotent stem cells; diabetes; insulin independence; islet transplantation; personalized medicine; regenerative medicine; stem-cell-derived islets.

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Conflict of interest statement

Declaration of interests H.D. is a scientific advisor at Hangzhou Reprogenix Bioscience. G.M. and S.L. are employees of Hangzhou Reprogenix Bioscience. Y.D. is a former employee of Hangzhou Reprogenix Bioscience and is now affiliated with the Hangzhou Institute of Medicine, Chinese Academy of Sciences. H.D., Y.D., G.M., and Z.Z. have patent applications related to this work.

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