NCT07754175招募中不适用
A Multicenter, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of FURESTEM-OA-Kit Inj. in Knee Osteoarthritis Patients Who Received Placebo in the K0701 Phase 2a Trial
Kang Stem Biotech Co., Ltd.2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年7月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Event, AESI(Adverse Event of Special Interest)
研究概览
简要总结
A Multicenter, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of FURESTEM-OA-Kit Inj. in Knee Osteoarthritis Patients Who Received Placebo in the K0701 Phase 2a Trial
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
- •Participants who received placebo in the K0701 clinical trial and completed the Long-term follow-up study
- •Participants who voluntarily provide written informed consent to participate in this extension study
排除标准
- •Participants meeting any of the following criteria:
- •Participants whom the investigator considers unsuitable for participation in this extension study.
- •Pregnant or breastfeeding women, and women of childbearing potential or men who do not agree to use an appropriate method of contraception during the study
结局指标
主要结局
Incidence of Adverse Event, AESI(Adverse Event of Special Interest)
时间窗: 5 years follow-up after treatment
次要结局
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)(Month 12, Month 24 after treatment)
- Whole-Organ Magnetic Resonance Imaging Score (WORMS) score(Month 12, Month 24 after treatment)
- Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)(Month 3, Month 6, Month 12, Month 24, Month 60 after treatment)
- Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)(Month 3, Month 6, Month 12, Month 24, Month 60 after treatment)
- Changes in 100-mm VAS(Month 3, Month 6, Month 12, Month 24, Month 60 after treatment)
- Changes in International Knee Documentation Committee Scoring System (IKDC)(Month 3, Month 6, Month 12, Month 24, Month 60 after treatment)
- Evaluation of International K&L grade(X-ray)(Month 12, Month 24 after treatment)
研究者
研究点 (2)
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