天津市第一中心医院沈中阳等研究人员合作,在一名1型糖尿病患者的腹部前直肌鞘下移植化学诱导的多能干细胞来源的胰岛。这一研究成果于2024年9月25日在线发表在国际学术期刊《细胞》上。
研究人员报告了来自一名患者的1年结果,作为对一项首例人类I期临床试验(ChiCTR2300072200)的初步分析,该试验评估在1型糖尿病治疗中,自体移植化学诱导的多能干细胞来源的胰岛(CiPSC胰岛)在腹部前直肌鞘下的可行性。患者在移植后75天开始实现持续的胰岛素独立。
患者的目标血糖范围时间从基线的43.18%增加到移植后第4个月的96.21%,伴随糖化血红蛋白的下降,后者是长期系统性葡萄糖水平的非糖尿病指标。
此后,患者呈现稳定的血糖控制状态,目标血糖范围时间超过98%,糖化血红蛋白维持在约5%。在1年时,临床数据满足所有研究终点,且未出现移植相关异常。这名患者的良好结果表明,进一步评估1型糖尿病中CiPSC胰岛移植的临床研究是需要的。
附:英文原文
Title: Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient
Author: 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, Na Liu, Yanling Wei, Xuejie Ding, Yue Pu, Yixiang Zhan, Yu Luo, Peng Sun, Shuangshuang Xie, Jiuxia Yang, Yiqi Weng, Chunlei Zhou, Zhenglu Wang, Shuang Wang, Hongkui Deng, Zhongyang Shen
Issue&Volume: 2024-09-25
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.
DOI: 10.1016/j.cell.2024.09.004
Source: https://www.cell.com/cell/abstract/S0092-8674(24)01022-5