中国神经再生研究(英文版) ›› 2023, Vol. 18 ›› Issue (9): 1999-2004.doi: 10.4103/1673-5374.366489

• 原著:脑损伤修复保护与再生 • 上一篇    下一篇

负载人脐带间充质干细胞可注射胶原支架能促进自发性脑出血神经功能的恢复:I期临床试验

  

  • 出版日期:2023-09-15 发布日期:2023-03-06
  • 基金资助:
    国家重点研发计划项目(2016YFC1101500),国家自然科学基金项目(11932013和11672332)

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

Xiao-Yin Li1, #, Wu-Sheng Deng2, #, Zi-Qi Wang1, 3, #, Zheng-Chao Li1, Shu-Lian Chen1, Zhen Song1, 3, Quan Zhang1, Jin Liang1, *, Xu-Yi Chen1, *#br#   

  1. 1Characteristic Medical Center of Chinese People’s Armed Police Force, Tianjin Key Laboratory of Neurotrauma Repair, Tianjin, China; 2Department of Neurosurgery, Dazhou Second People’s Hospital, Dazhou, Sichuan Province, China; 3Graduate School of Tianjin University of Traditional Chinese Medicine, Tianjin, China
  • Online:2023-09-15 Published:2023-03-06
  • Contact: Xu-Yi Chen, PhD, chenxuyi1979@126.com; Jin Liang, MD, liangjin1975@126.com.
  • Supported by:
    This work was supported by the National Key Research and Development Plan of China, No. 2016YFC1101500 (to ZS), and the National Natural Science Foundation of China, Nos. 11932013 and 11672332 (both to XYC).

摘要:

动物实验显示,负载人脐带间充质干细胞的可注射胶原支架可促进脊髓损伤的恢复,为了解其是否可用于治疗自发性脑出血,开展了非随机对照I期临床试验,于2016年5月至2020年12月在中国武警特色医学中心招募了自发性脑出血患者,基于临床情况和患者获益将患者分为对照组(n = 18)、人脐带间充质干细胞组(n = 4)和联合组(n = 8)。其中对照组未进行移植治疗,人脐带间充质干细胞组植入人脐带间充质干细胞,而联合组植入负载人脐带间充质干细胞的可注射胶原支架。结果可见,与未移植患者以及仅移植人脐带间充质干细胞的患者相比,联合组患者运动及认知功能改善更为显著,脑出血病灶显著缩小,且所有受试者均耐受性良好,未见与移植相关的严重不良事件。这显示出负载人脐带间充质干细胞的可注射胶原支架在治疗自发性脑出血方面的潜力。

https://orcid.org/0000-0002-0420-8349 (Xu-Yi Chen)

关键词: 自发性脑出血, 胶原支架, 人脐带间充质干细胞, 细胞移植, 神经功能, 安全性, 有效性, 疗效, 临床试验

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. 

Key words: clinical trial, collagen scaffold, efficacy, human umbilical cord-derived mesenchymal stem cells, human, safe, neurological recovery, spontaneous intracerebral hemorrhage, transplantation