A Phase II Simon Two-Stage Efficacy Study of Intracerebral CTX-DP in Patients with Stable Paresis of the Arm Following an Ischaemic Stroke

脑内 CTX-DP 对缺血性中风后手臂稳定麻痹患者的 II 期西蒙两阶段疗效研究

• 批准号: 101618
• 金额: $ 160.11万
• 依托单位: RENEURON LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2014
• 资助国家: 英国
• 起止时间: 2014 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=101618
• 关键词: Phase; II; Simon; Two; Stage

Disability affects approximately 50% of stroke survivors due to permanent loss of brain tissue. ReNeuron is testing the effectiveness of a unique stem cell product, called CTX, in disabled stroke patients. ReNeuron has developed CTX from human brain stem cells, with cell banks established to provide the large quantities needed for clinical use. The safety of CTX has been assessed in stroke-disabled patients in Scotland. Treatment of all patients in this Phase I clinical trial has been completed, with no reports to date of any serious side effects or worsening in disability in the patients. Sustained reductions in neurological impairment and spasticity have also been observed in most patients compared with their stable pre-treatment baseline performance. TSB support is needed to conduct a Phase II study in up to 41 patients with upper limb paralysis at 2-4 months after their strokes. This proposed clinical trial will determine if CTX produces clinically meaningful improvements in the use of the paralysed arm at 6 months post-treatment in a sufficient number of patients treated. Success in this project will represent a significant milestone for ReNeuron and for the wider stroke field.

大约50%的中风幸存者由于脑组织的永久性丧失而残疾。ReNeuron正在测试一种独特的干细胞产品CTX在残疾中风患者中的有效性。ReNeuron从人脑干细胞中开发了CTX，建立了细胞库以提供临床使用所需的大量细胞。CTX的安全性已经在苏格兰的中风残疾患者中进行了评估。该I期临床试验中所有患者的治疗均已完成，迄今为止未报告任何严重副作用或患者残疾恶化。与稳定的治疗前基线表现相比，在大多数患者中也观察到神经功能缺损和痉挛状态持续减轻。TSB支持需要在多达41名中风后2-4个月上肢瘫痪的患者中进行II期研究。这项拟议的临床试验将确定在足够数量的接受治疗的患者中，CTX是否在治疗后6个月时对瘫痪手臂的使用产生具有临床意义的改善。该项目的成功将代表ReNeuron和更广泛的中风领域的一个重要里程碑。