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含人脐带间充质干细胞的可注射胶原蛋白支架促进自发性脑出血患者功能恢复:I期临床试验

Injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells promotes functional recovery in patients with spontaneous intracerebral hemorrhage: phase I clinical trial.

作者信息

Li Xiao-Yin, Deng Wu-Sheng, Wang Zi-Qi, Li Zheng-Chao, Chen Shu-Lian, Song Zhen, Zhang Quan, Liang Jin, Chen Xu-Yi

机构信息

Characteristic Medical Center of Chinese People's Armed Police Force, Tianjin Key Laboratory of Neurotrauma Repair, Tianjin, China.

Department of Neurosurgery, Dazhou Second People's Hospital, Dazhou, Sichuan Province, China.

出版信息

Neural Regen Res. 2023 Sep;18(9):1999-2004. doi: 10.4103/1673-5374.366489.

Abstract

Animal experiments have shown that injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells can promote recovery from spinal cord injury. To investigate whether injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells can be used to treat spontaneous intracerebral hemorrhage, this non-randomized phase I clinical trial recruited patients who met the inclusion criteria and did not meet the exclusion criteria of spontaneous intracerebral hemorrhage treated in the Characteristic Medical Center of Chinese People's Armed Police Force from May 2016 to December 2020. Patients were divided into three groups according to the clinical situation and patient benefit: control (n = 18), human umbilical cord-derived mesenchymal stem cells (n = 4), and combination (n = 8). The control group did not receive any transplantation. The human umbilical cord-derived mesenchymal stem cells group received human umbilical cord-derived mesenchymal stem cell transplantation. The combination group received injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells. Patients who received injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells had more remarkable improvements in activities of daily living and cognitive function and smaller foci of intracerebral hemorrhage-related encephalomalacia. Severe adverse events associated with cell transplantation were not observed. Injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells appears to have great potential treating spontaneous intracerebral hemorrhage.

摘要

动物实验表明,含人脐带间充质干细胞的可注射胶原蛋白支架可促进脊髓损伤的恢复。为研究含人脐带间充质干细胞的可注射胶原蛋白支架是否可用于治疗自发性脑出血,这项非随机I期临床试验招募了2016年5月至2020年12月在中国人民武装警察部队特色医学中心接受治疗的符合自发性脑出血纳入标准且不符合排除标准的患者。根据临床情况和患者获益情况将患者分为三组:对照组(n = 18)、人脐带间充质干细胞组(n = 4)和联合组(n = 8)。对照组未接受任何移植。人脐带间充质干细胞组接受人脐带间充质干细胞移植。联合组接受含人脐带间充质干细胞的可注射胶原蛋白支架。接受含人脐带间充质干细胞的可注射胶原蛋白支架的患者在日常生活活动和认知功能方面有更显著的改善,且脑出血相关脑软化灶更小。未观察到与细胞移植相关的严重不良事件。含人脐带间充质干细胞的可注射胶原蛋白支架在治疗自发性脑出血方面似乎具有巨大潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd87/10233785/72c5e44f7aaa/NRR-18-1999-g002.jpg

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