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针对急性缺血性中风的全基性人类带血:I期临床试验

Raymond Y Lo^1,2,3, Yuncin Luo^1,4, Shu-Cin Chen²

¹Department of Neurology, Taitung St. Mary's Hospital, Taitung, Taiwan.

Tzu chi medical journal

|July 31, 2025

概括

静脉注射人类带血细胞 (hUCB) 输液对急性缺血性中风 (AIS) 患者有前途. 这一第一阶段试验发现hUCB安全且耐受良好,中风量表显著改善,需要进一步研究.

科学领域:

神经科学是一个神经科学.
再生医学是一种再生医学.
临床试验临床试验

背景情况:

急性缺血性中风 (AIS) 带来了严重的残疾风险.
人类带血细胞 (hUCB) 提供潜在的神经保护性益处.
研究AIS的新型治疗策略至关重要.

研究的目的:

在AIS患者中评估静脉注射 (IV) hUCB输液的安全性和耐受性.
评估hUCB治疗对神经功能的初步疗效.
建立未来随机对照试验的基础.

主要方法:

一个为期12个月的,开放的,单中心的I期临床试验.
包括45-80岁的AIS患者,确诊心脏病发作和NIHSS分数在6-18之间.
单次IV hUCB剂量,随后进行曼尼托尔输注;对不良事件和功能评分 (NIHSS,BI,BBS) 的监测.

主要成果:

六名患者完成了试验,平均年龄为65.8岁.
发生了40次不良事件 (AE),其中9次是严重的AE; 过渡性多形红斑和出血症可能与hUCB有关.
在治疗后的NIHSS和巴特尔指数 (BI) 得分中观察到显著的改善;伯格平衡量 (BBS) 显示数字增加.

结论:

静脉注射hUCB输液在AIS患者中是安全的,并且耐受性良好.
初步的疗效数据表明,在AIS中hUCB具有治疗潜力.
结果支持进入II期随机化,安慰剂对照试验.

关键词:

急性缺血性中风是一次急性缺血性中风.不良事件不良事件不良事件人的带血是人类的带血.美国国立卫生研究院中风量表.第一期临床试验临床试验.

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