针对急性缺血性中风的全源干细胞疗法:TREASURE 2/3期随机临床试验
Kiyohiro Houkin1, Toshiya Osanai2, Shinichiro Uchiyama3,4
1Hokkaido University, Sapporo, Japan.
JAMA neurology
|January 16, 2024
概括
在临床试验中,MultiStem细胞疗法被发现对急性缺血性中风患者是安全的,但并没有显著改善短期结果. 需要进一步的研究来确定潜在益处的特定患者标准.
科学领域:
- 再生医学是一种再生医学.
- 神经科学是一个神经科学.
- 临床试验 临床试验
背景情况:
- 细胞疗法为治疗中风和其他疾病提供了一个有希望的途径.
- 对于缺血性中风,MultiStem (HLCM051) 是一种来自骨髓的原始细胞产品,其疗效仍未确定.
研究的目的:
- 为了评估MultiStem的安全性和有效性,当在缺血性中风发作后18至36小时内给患者服用时.
主要方法:
- 一个多中心,双盲,安慰剂控制的2/3期随机临床试验 (TREASURE) 涉及206名急性缺血性中风患者.
- 患者在中风发作后18至36小时内接受静脉MultiStem (1.2亿个细胞) 或安慰剂.
- 主要终点包括安全性和90天的优异功能结果,通过修改的兰金度量 (mRS),NIHSS和巴特尔指数得分的复合定义.
主要成果:
- 在MultiStem和安慰剂组之间的初级或二级终点中没有发现显著差异.
- 在90天内获得优异结果的患者比例相似:MultiStem11.5%与安慰剂9.8%相比 (P=.90).
- 治疗组和安慰剂组之间的不良事件频率是可比的,这表明了类似的安全性概况.
结论:
- 在缺血性中风发作后18至36小时内静脉注射MultiStem细胞疗法是安全的,但没有证明短期有效性.
- 探索性分析表明,可能需要进一步调查以确定可能受益于MultiStem治疗的特定患者亚组.
- 需要进行额外的研究才能充分确定MultiStem在缺血性中风治疗中的治疗潜力.
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