Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 5
- 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 II trial (NCT05182034) will be followed-up until 60 months.
详细描述
The subjects will be followed up at 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
- Double (Participant, Care Provider)
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 II clinical trial.
- •Subject who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.
排除标准
- •Subject who were not enrolled in phase II 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
研究组 & 干预措施
SMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01 (low-dose, 4.0 x 10^6 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
干预措施: SMUP-IA-01(low-dose) (Biological)
SMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01 (mid-dose, 1.0 x 10^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
干预措施: SMUP-IA-01(mid-dose) (Biological)
High Hyal Plus Inj.
A single knee administration of High Hyal Plus Inj.(1% Sodium Hyaluronate 20mg/2ml)
干预措施: High Hyal Plus (Drug)
结局指标
主要结局
Change of total score in WOMAC (Western Ontario and McMaster University)
时间窗: Time Frame: 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 of score in WOMAC three subscales (Pain, stiffness, physical function) aginst MP-SMUP-IA-01-P02's baseline.(Time Frame: Month 12, 24, 36, 48 and 60 after treatment)
- Change of score in 100 mm VAS (Visual Analogue Scale)(Time Frame: Month 12, 24, 36, 48 and 60 after treatment)
- Change of score in IKDC(International Knee Documentation Committee)(Time Frame: Month 12, 24, 36, 48 and 60 after treatment)
- Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)(Time Frame: Month 12 and 24 after treatment)
- Change in K&L(Kellgren-Lawrence) grade(Time Frame: Month 12, 24 and 60 after treatment)
- Change in joint space width(Time Frame: Month 12, 24 and 60 after treatment)
- Change in mechanical axis, anatomical axis(Time Frame: Month 12, 24 and 60 after treatment)