NCT03069404已完成不适用
INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI, an Investigator Initiated Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- American Spinal Injury Association (ASIA) Impairment Scale Improvement
研究概览
简要总结
The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury.
Subjects will be monitored at routine intervals for safety and preliminary efficacy for 5 years post-transplantation of the Phase I/II investigation CL-N02-SC.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial
- •Must be able to provide written informed consent prior to any study related procedures
- •Must agree to comply in good faith with all conditions of the study and to attend all required study visits
- •Female subjects who are pregnant remain eligible for enrollment, but the MRI examination will not be performed during the pregnancy. Female subjects of child-bearing potential must have a negative urine pregnancy test prior to the MRI examination
排除标准
- •Subjects have received or are receiving off-protocol immunosuppressive medications
- •Subjects who after completion of CL-N02-SC have entered, or are about to enter any other interventional study
结局指标
主要结局
American Spinal Injury Association (ASIA) Impairment Scale Improvement
时间窗: 36 months after transplantation of HuCNS-SC®
Evidence of improvement in ASIA impairment scale as confirmed by neurological examination
次要结局
未报告次要终点
研究者
研究点 (1)
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