NCT04427930进行中（未招募）3 期
Long-Term Safety and Efficacy Extension Study Of Autologous Adipose-Derived Mesenchymal Stem Cells 『JOINTSTEM』 in Patients With Knee Osteoarthiritis: A Phase III Extension Study
R-Bio8 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2020年4月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 129
- 试验地点
- 8
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this follow-up study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of Jointstem Phase 3 Clinical Trial
- •Participates who signed informed consent document of this study
排除标准
- •No applicable
结局指标
主要结局
Adverse Events
时间窗: 5 Years
Incidence of adverse events from baseline to 5 Years
次要结局
- WOMAC 3 subscale score(5 Years)
- SF-36(5 Years)
- Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline(5 Years)
- Measuring of Kellgren-Lawrence grade(1, 2, 3, 4, 5 Years)
- Measuring of Femoro-tibial anatomical angle(FTA)(1, 2, 3, 4, 5 Years)
- Measuring of Hip-Knee-Ankle angle(HKA)(1, 2, 3, 4, 5 Years)
- Measuring of Joint Space Width(1, 2, 3, 4, 5 Years)
- MRI scan(1, 2, 3, 4, 5 Years)
研究者
研究点 (8)
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