NCT02302157已完成1 期
A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 17
- 主要终点
- Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection
研究概览
简要总结
The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3
- •Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5
- •Last fully preserved single neurological level (SNL) from C-4 to C-7
- •From 18 through 69 years of age at time of injury
- •Single spinal cord lesion on a post-stabilization magnetic resonance imaging (MRI) scan, with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring
- •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 37 days following injury
- •Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days following SCI
排除标准
- •SCI due to penetrating trauma
- •Traumatic anatomical transection or laceration of the spinal cord based on prior surgery or MRI
- •Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations
- •Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised
- •Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
- •History of any malignancy (except non-melanoma skin cancers)
- •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
Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection
时间窗: One Year
Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection
次要结局
- Neurological Function as Measured by Upper Extremity Motor Scores and Motor Level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examinations as Secondary End Point - 365 Days After Injection of AST-OPC1(One Year)
研究者
研究点 (17)
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