NCT02137915终止不适用
Long-Term Follow-up Study of the Phase I/II Safety and Preliminary Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Frequency and types of serious adverse events
研究概览
简要总结
This study is being done to determine the long-term safety and possible benefits of transplanted Human Central Nervous System Stem Cells (HuCNS-SC) for patients with Geographic Atrophy of Age-Related Macular Degeneration. This long-term follow-up study is limited to those individuals who received a transplant of HuCNS-SC cells into one of their eyes as part of the CL-N01-AMD study. No additional study product will be given in this 4-year long-term follow-up study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have completed Study CL-N01-AMD
- •Must be able to provide written informed consent prior to any study related procedures
- •Agree to comply in good faith with all conditions of the study and to attend all required study visits
排除标准
- •Inability to comply with study procedures or visits
- •Since enrolling in Study CL-N01-AMD, have entered, or are about to enter another investigational study that, in the opinion of the Principal Investigator (PI), might confound study interpretation.
- •Received off-study immunosuppressive agents in the lead-in study or are receiving any immunosuppressive agents since completing the lead-in study
结局指标
主要结局
Frequency and types of serious adverse events
时间窗: At each of 11 visits over a period of 48 months
次要结局
- Frequency and types of adverse events(At each of 11 visits over a period of 48 months)
研究者
研究点 (1)
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