慢性缺血性中风患者的人类神经干细胞 (PISCES):第一阶段,首次对人进行研究
Dheeraj Kalladka1, John Sinden2, Kenneth Pollock2
1Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK.
Lancet (London, England)
|August 8, 2016
概括
一种干细胞疗法CTX-DP在多达2000万细胞的中风患者中没有出现不良反应. 这种试验性治疗证明了神经功能的改善,支持进一步的中风恢复临床试验.
科学领域:
- 神经科学
- 复原医学
- 临床神经学
背景情况:
- CTX0E03是一种用于开发CTX-DP的神经干细胞系.
- 在CTX-DP治疗中风后,在小鼠中进行的临床前研究显示,有剂量依赖的感觉运动功能的改善.
- 这些发现促使研究CTX-DP在人类中风患者的安全性和耐受性.
研究的目的:
- 在经历过缺血性中风的患者中评估CTX- DP的安全性和耐受性.
- 评估CTX-DP脑内注射后的神经变化和不良事件.
主要方法:
- 进行了一项开放式,单位,剂量升级的研究.
- 11名60岁以上的男性患者经过缺血性中风后获得单剂量CTX- DP (2 - 20百万细胞) 通过立体注射.
- 安全终点包括2年随访期间的不良事件和神经学评估.
主要成果:
- 在11名参与者中没有观察到免疫或细胞相关的不良事件.
- 发现了与手术相关的不良反应或伴随疾病的不良反应.
- 五名患者在注射通道周围显示T2加权的MRI超强度.
- 在2年后,NIHSS得分的中位数提高了2分.
结论:
- 在患有慢性缺血性中风的患者中,CTX-DP的单剂量高达2000万个细胞被发现是安全的,并且耐受良好.
- 观察到的神经改善表明CTX-DP对中风患者的治疗具有前景.
- 基于这些安全性和初步疗效发现,需要对CTX- DP进行进一步的临床研究.
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