Long Term Follow-up of Subjects Who Received GRNOPC1
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Incidence and severity of adverse events (AEs)
研究概览
简要总结
This is a LTFU study for thoracic SCI subjects that were administered GRNOPC1 cells in the main study CP35A007.
详细描述
Study CP35A008 is a Phase 1, multi-center long term follow-up (LTFU) study for five (5) subjects with complete thoracic SCI that were administered 2 million GRNOPC1 cells in the main study CP35A007. The purpose of this study is to monitor long-term safety in subjects for 15 years post GRNOPC1 administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects who received administration of GRNOPC1 under clinical study protocol CP35A007.
排除标准
- •There are no exclusion criteria for this LTFU study.
结局指标
主要结局
Incidence and severity of adverse events (AEs)
时间窗: Up to 15 years after GRNOPC1 injection
Information will be collected on all adverse events through Year 5 and on late-occurring adverse events (Years 6-15) related to any changes in neurological condition, a fever of unknown etiology, and the development of neoplasias and/or neurological disorders.
次要结局
未报告次要终点