NCT01321333已完成1 期
A Phase I/II Study of the Safety and Preliminary Efficacy of Intramedullary Spinal Cord Transplantation of Human Central Nervous System (CNS) Stem Cells (HuCNS-SC®) in Subjects With Thoracic (T2-T11) Spinal Cord Trauma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 5
- 主要终点
- Types and frequencies of adverse events and serious adverse events
研究概览
简要总结
This study will evaluate the effect of single transplantation of HuCNS-SC cells into the thoracic spinal cord of patients with sub-acute spinal cord injury.
详细描述
Study subjects will receive immunosuppression for nine months following transplantation. All enrolled subjects will be followed for one year following transplantation and then will be enrolled in a separate long-term follow-up study for an additional four years.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2-T11 thoracic spinal cord injury based on American Spinal Injury Association (ASIA) level determination by the principal investigator (PI)
- •T2-T11 thoracic spinal cord injury as assessed by magnetic resonance imaging (MRI) and/or computerized tomography (CT)
- •ASIA Impairment Scale (AIS) Grade A, B, or C
- •Minimum of six weeks post injury for the initiation of screening
- •Must have evidence of preserved conus function
- •Must be at stable stage of medical recovery after injury
排除标准
- •History of traumatic brain injury without recovery
- •Penetrating spinal cord injury
- •Evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma
- •Previous organ, tissue or bone marrow transplantation
- •Previous participation in any gene transfer or cell transplant trial
- •Current or prior malignancy
结局指标
主要结局
Types and frequencies of adverse events and serious adverse events
时间窗: One year after transplant
Analysis of types and frequencies of adverse events one year after transplant.
次要结局
未报告次要终点
研究者
研究点 (5)
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