NCT03509025已完成2 期
Open, Multicenter Follow-up Trial About Active Group of Phase IIb Clinical Trial of JOINTSTEM in Patients With Degenerative Arthritis
R-Bio2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年2月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
This study is a long term follow-up study to investigate the safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must consent in writing to participate in the study by signing and dating an informed consent document
- •Patients who transplanted Jointstem on phase 2b clinical trial
排除标准
- •Preparing for Pregnancy or Pregnant women or lactating mothers.
- •Patients who the principal investigator considers inappropriate for the clinical tria
研究组 & 干预措施
Long Term Follow-up after Jointstem Transplantation
Experimental
干预措施: Jointstem (Drug)
结局指标
主要结局
Adverse Events
时间窗: 60 months
Incidence of adverse events from baseline to 60 months
次要结局
- WOMAC 3 subscale score(Baseline and 12 months)
- X-ray(Baseline and 12 months)
- WOMAC score(Baseline and 12 months)
研究者
研究点 (2)
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