NCT06013306尚未招募不适用
Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study
Kang Stem Biotech Co., Ltd.0 个研究点目标入组 58 人开始时间: 2023年9月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 主要终点
- Number of AESI
研究概览
简要总结
Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj
- •Those who understand and voluntarily sign an informed consent form
- •exclusion criteria
排除标准
- 未提供
结局指标
主要结局
Number of AESI
时间窗: 5 years follow-up after treatment
Number of SS
时间窗: 5 years follow-up after treatment
次要结局
- Changes in 100-mm VAS(1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment)
- Changes in International Knee Documentation Committee Scoring System (IKDC)(1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment)
- Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)(1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment)
- Evaluation of International K&L grade(X-ray)(1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment)
- Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)(1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment)
- Whole-Organ Magnetic Resonance Imaging Score (WORMS) score(1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment)
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)(1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment)
研究者
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