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

IF 45.5 1区生物学 Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY

Cell Pub Date : 2024-09-25 DOI:10.1016/j.cell.2024.09.004

Shusen Wang, Yuanyuan Du, Boya Zhang, Gaofan Meng, Zewen Liu, Soon Yi Liew, Rui Liang, Zhengyuan Zhang, Xiangheng Cai, Shuangshuang Wu, Wei Gao, Dewei Zhuang, Jiaqi Zou, Hui Huang, Mingyang Wang, Xiaofeng Wang, Xuelian Wang, Ting Liang, Tengli Liu, Jiabin Gu, Zhongyang Shen

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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.

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在一名 1 型糖尿病患者的腹部前直肌鞘下移植化学诱导多能干细胞衍生的小胰岛

我们报告了一名患者的1年结果，作为首次人体I期临床试验（ChiCTR2300072200）的初步分析，该试验评估了在腹部前直肌鞘下自体移植化学诱导多能干细胞衍生胰岛（CiPSC胰岛）治疗1型糖尿病的可行性。患者在移植后75天开始实现了胰岛素的持续独立。移植后第 4 个月，患者的目标血糖范围时间从基线值 43.18% 增加到 96.21%，同时糖化血红蛋白也有所下降，而糖化血红蛋白是全身血糖水平长期处于非糖尿病水平的指标。此后，患者血糖控制稳定，目标血糖范围时间为 98%，糖化血红蛋白约为 5%。一年后，临床数据达到了所有研究终点，没有发现与移植相关的异常。该患者的良好结果表明，有必要进一步开展临床研究，评估CiPSC-小鼠移植治疗1型糖尿病的效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cell 生物-生化与分子生物学

CiteScore

110.00

自引率

0.80%

发文量

396

审稿时长

2 months

期刊介绍： Cells is an international, peer-reviewed, open access journal that focuses on cell biology, molecular biology, and biophysics. It is affiliated with several societies, including the Spanish Society for Biochemistry and Molecular Biology (SEBBM), Nordic Autophagy Society (NAS), Spanish Society of Hematology and Hemotherapy (SEHH), and Society for Regenerative Medicine (Russian Federation) (RPO). The journal publishes research findings of significant importance in various areas of experimental biology, such as cell biology, molecular biology, neuroscience, immunology, virology, microbiology, cancer, human genetics, systems biology, signaling, and disease mechanisms and therapeutics. The primary criterion for considering papers is whether the results contribute to significant conceptual advances or raise thought-provoking questions and hypotheses related to interesting and important biological inquiries. In addition to primary research articles presented in four formats, Cells also features review and opinion articles in its "leading edge" section, discussing recent research advancements and topics of interest to its wide readership.