Long-term Follow-up Study of Safety and Explore Efficacy in Subjects Who Completed SMUP-IA-01 Phase Ⅰ Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change of total score in WOMAC (Western Ontario and McMaster University)
研究概览
简要总结
This is a follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage of the Phase I trial (NCT04037345 ) will be followed-up until 60 months.
详细描述
The subjects will be followed up at 6-month, 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase I clinical trial.
- •Subjects who have been treated with either SMUP-IA-01 at least 6 months ago.
- •Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.
排除标准
- •Subjects who were not enrolled in phase 1 clinical trial of SMUP-IA-01 for assessing safety and explore efficacy.
- •Other subjects, excluding those listed above, who were deemed unsuitable by the PI
结局指标
主要结局
Change of total score in WOMAC (Western Ontario and McMaster University)
时间窗: Month 12, 24, 36, 48 and 60 after treatment
Comparing WOMAC total score changes with baseline scores of SMUP-IA-01 phase I trial and scores of f/u study at 12 months, 24 months, 36 months, 48 months and 60months after treatment (score range 0-96, higher score represent worse symptoms).
次要结局
- Change in joint space width(Month 12 and 24 after treatment)
- Change of score in WOMAC three subscales (Pain, stiffness, physical function)(Month 12, 24, 36, 48 and 60 after treatment)
- Change of score in IKDC(International Knee Documentation Committee)(Month 12, 24, 36, 48 and 60 after treatment)
- Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)(Month 12 and 24 after treatment)
- Change in K&L(Kellgren-Lawrence) grade(Month 12 and 24 after treatment)
- Change in mechanical axis, anatomical axis(Month 12 and 24 after treatment)
- Rate of surgery to treat application site after treatment of SMUP-IA-01(Month 6, 12, 24, 36, 48 and 60 after treatment)
- Changes in biomarker(Month 12 after treatment)
- Change of score in 100 mm VAS (Visual Analogue Scale)(Month 12, 24, 36, 48 and 60 after treatment)