A Phase 3, Multicentre, Randomised, Double Blind, Placebo-controlled Study to Evaluate the Effectiveness, Safety, and Tolerability of MAG200 (an Allogeneic Adipose-derived Mesenchymal Stem Cell Preparation) Administered by Intra-articular Injection to Adult Participants With Symptomatic Osteoarthritis of the Knee.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 573
- 主要终点
- To assess the effect of MAG200 on osteoarthritis pain and function
研究概览
简要总结
The purpose of this study is to confirm whether MAG200 (20M or 100M) will improve pain and function of participants with osteoarthritis of the knee compared with placebo. In addition, the two strengths of MAG200 will be compared.
In this study, participants will receive a single injection of placebo or allogeneic ADMSCs (MAG200) administered by IA injection. Participants will be randomised to receive placebo, or MAG200 at a dose of 20 million cells (20M), or MAG200 at a dose of 100 million cells (100M).
It is anticipated that the study will run for approximately 48 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
20M MAG200
Participants in this arm will receive MAG200 at a dose of 20 million cells (20M).
干预措施: allogeneic human adipose-derived mesenchymal stem cells (Biological)
100M MAG 200
Participants in this arm will receive MAG200 at a dose of 100 million cells (100M)
干预措施: allogeneic human adipose-derived mesenchymal stem cells (Biological)
结局指标
主要结局
To assess the effect of MAG200 on osteoarthritis pain and function
时间窗: 12 months
Co-primary endpoints: * Change from baseline in pain by Knee Injury and Osteoarthritis Outcome Score pain subscale (KOOS Pain): 0-100 scale (0=extreme knee pain, 100=no knee pain) * Change from baseline in function as measured by Knee Injury and Osteoarthritis Outcome Score function in daily living subscale (KOOS-ADL): 0 to 100 scale (0=extreme knee problems, 100=no knee problems)
次要结局
- To assess the effect of MAG200 on osteoarthritis pain(1, 3, 6, 9, and 12 months)
- To assess the response rate of MAG200(1, 3, 6, 9, and 12 months)
- To assess the effect of MAG200 on radiological progression(12 months)