A Randomized, Single-blind, Phase II Clinical Trial to Compare ReJoinTM (Autologous Adipose-derived Mesenchymal Progenitor Cells)to Sodium Hyaluronate Injection for the Patients With Knee Osteoarthritis Cartilage Defects
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- WOMAC scores
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of ReJoinTM for the Knee Osteoarthritis patients with Cartilage Defects comparing to Sodium Hyaluronate Injection.
详细描述
This is a randomized, single-blind,phase II clinical trial.
At least 28 subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects will be randomly distributed 1:1 to the treatment group or the control group after signing the ICF and screening tests.The treatment will accept ReJoinTM at the first and fourth week,and Sodium Hyaluronate Injection at the second and third week.The control group will accept Sodium Hyaluronate Injection weekly ,and four injections in total.The duration of the therapy is 48 weeks.
In addition, external control will be added if necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old, KOA couse ≤ 10 years
- •Kellgren-Lawrence Ⅰ-Ⅲ
- •VAS core >6， more than 4 months
- •Signed informed consent from the subject
- •cartilage defect 2-6cm2
排除标准
- •Pregnancy test positive.
- •Subject infected with hepatitis C, HIV or syphilis.
- •Subject enrolled in any other cell therapy studies within the past 30 days.
- •Subject deemed to be not suitable for the study by the investigator
研究组 & 干预措施
ReJoinTM Group
Subjects in this Group will receive ReJoinTM injections on day 1 and day 22, and Sodium Hyaluronate injection on day 8 and day 15.
干预措施: ReJoinTM (Biological)
Sodium Hyaluronate Group
subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22.
干预措施: Sodium Hyaluronate (Drug)
结局指标
主要结局
WOMAC scores
时间窗: 48 weeks
WOMAC scoring will be performed 48 weeks after the first injection
次要结局
- VAS scores(0 day、8 weeks、24 weeks、36 weeks and 48 weeks)
- SF-36 scores(0 day、8 weeks、24 weeks、 36 weeks and 48 weeks)
- Outbridge scoring(1 day and 24 weeks)
- CRP(0 day、8 weeks、24 weeks、 36 weeks and 48 weeks)
- Cartilage defect size(0 day and 24 weeks)
- Cartilage volume(0 day and 24 weeks)