NCT01217008已完成1 期
A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 10
- 主要终点
- Safety
研究概览
简要总结
The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation < 5 levels
- •Last fully preserved neurological level from T-3 through T-11
- •From 18 through 65 years of age at time of injury
- •Single spinal cord lesion
- •Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 11 days following injury
- •Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI
排除标准
- •SCI due to penetrating trauma
- •Traumatic anatomical transection or laceration of the spinal cord
- •Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations
- •Inability to communicate effectively with neurological examiner
- •Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
- •History of any malignancy
- •Pregnant or nursing women
- •Body mass index (BMI) > 35 or weight > 300 lbs.
- •Active participation in another experimental procedure/intervention
结局指标
主要结局
Safety
时间窗: One year
The primary endpoint is safety, as measured by the frequency and severity of adverse events within 1 year (365 days) of GRNOPC1 injection that are related to GRNOPC1, the injection procedure used to administer GRNOPC1, and/or the concomitant immunosuppression administered.
次要结局
- Neurological function(One year)
研究者
研究点 (10)
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