A Phase 1/Phase 2a Safety and Tolerability Study of Intracerebral Transplantation of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS) and Early Evaluation of Potentially Useful Efficacy Parameters
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
Evaluation of the safety and tolerability of escalating doses of NR1 administered intracerebrally at a single time-point post-injury to subjects with chronic ISS with or without cortical stroke.
详细描述
Evaluation of the safety and tolerability of escalating doses of NR1 administered intracerebrally at a single time-point post-injury to subjects with chronic ISS with or without cortical stroke. The study will be a dose escalation using up to 4 cohorts each at a single dose level, of intracerebral administration of NR1 cells. Secondary objectives are to evaluate clinical and radiologic responses as well as utility of efficacy measurement tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75 years
- •History of ischemic subcortical stroke in the middle cerebral artery and/or lenticulostriate artery 6 to 60 months from time of stroke
- •Ability of subject to understand and provide written Informed Consent
- •Willing to take tacrolimus (Prograf) 2 days before and for 2 months after transplant
排除标准
- •Stroke lesion less than 1 cubic centimeter or greater than 100 cubic centimeters measured by MRI
- •Index stroke is lacunar infarct less than 1 year old
- •History or presence of any major neurological disease
- •History of active cancer other than basal or squamous cell skin cancers
- •History of seizures
- •Pregnant or breast-feeding
研究组 & 干预措施
Neural Stem cells injected intracerebrally
Subject cohorts will be treated with increasing doses of Neural Stem Cells injected intracerebrally using a traditional 3+3 trial design
干预措施: Neural Stem Cells (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 0-12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Fugl Meyer (FM) motor score
时间窗: 0-12 months
Change in neurologic functional outcome to evaluate efficacy post-injection as defined by change in Fugl Meyer motor score in comparison to baseline
次要结局
未报告次要终点