NCT02163876终止2 期
A Single-Blind, Randomized, Parallel Arm, Phase II Proof-of-Concept Study of the Safety and Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Transplantation in Cervical Spinal Cord Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 14
- 主要终点
- Change from baseline in ISNCSCI upper extremity motor scores
研究概览
简要总结
This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects age 18 to 60 years.
- •Traumatic cervical spinal cord injury (cSCI) with C5-C7 motor levels according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) as determined by the Investigator.
- •American Spinal Injury Association Impairment Scale (AIS) Grades B or C
- •Minimum of 12 weeks post-injury prior to Screening
排除标准
- •History of penetrating SCI.
- •MRI evidence of complete spinal cord interruption .
- •Evidence of spinal instability, stenosis and/or persistent cord compression related to the initial trauma.
- •Prior participation in another investigational study within 90 days prior to Screening.
- •Previous organ, tissue, bone marrow transplantation, or gene transfer
- •History of malignancy (except non-melanoma skin cancers) that require(d) radiation and/or chemotherapy
研究组 & 干预措施
HuCNS-SC cells
Experimental
Intramedullary transplantation of HuCNS-SC cells in the cervical spine
干预措施: HuCNS-SC cells (Drug)
结局指标
主要结局
Change from baseline in ISNCSCI upper extremity motor scores
时间窗: Up to one year after enrollment
次要结局
- Number of participants with serious and non-serious adverse events(Up to one year from the time of enrollment)
研究者
研究点 (14)
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