Treatment of Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Physical function change
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of autologous adipose-derived mesenchymal stem cells (AMSCs) plus autologous platelet rich plasma (PRP) in the treatment of severe knee osteoarthritis.
详细描述
This is a single centered, randomized, single blind phase II clinical study. Patients will be divided into two groups of case and control. Patients of case group will receive intra-articular injection of autologous AMSCs suspended in 3 ml autologous PRP for 3 times, patients of control group will receive intra-articular injection of 3 ml of autologous PRP for 3 times. The investigators designed this clinical study to evaluate therapeutic effects of AMSCs in patients with severe knee osteoarthritis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has Kellgren and Lawrence grade II-IV primary osteoarthritis as determined by X-ray.
- •Subject's pain score is 8-13 points (Lequesne's index).
- •Ages between 40-70 years.
- •Signed informed consent from the subject.
排除标准
- •Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV
- •Subject not suitable for liposuction surgery.
- •Subject with hypersensitivity/allergy to anesthetic.
- •Subject's creatinine values higher than 1.6mg/dl.
- •Subject with body mass index, BMI over
- •Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
- •Subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
- •Subject enrolled in any other cell therapy studies within the past 30 days.
- •Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
- •Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
- •Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.
结局指标
主要结局
Physical function change
时间窗: From before randomization until 3, 6, and 12 months after treatment start.
Evaluation the physical function change measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.
Change in pain density
时间窗: From before randomization until 3, 6, and 12 months after treatment start.
Evaluation the changing of pain density measured by Visual Analogue Scale. Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
次要结局
- Cartilage repair(From before randomization until 3, 6, and 12 months after treatment start.)
- Change in MOS item short from health survey(SF-36)(From before randomization until 3, 6, and 12 months after treatment start.)
- Change in Lequesne Index(From before randomization until 3, 6, and 12 months after treatment start.)
- Change in knee society score (KSS)(From before randomization until 3, 6, and 12 months after treatment start.)
研究者
Peiwen Lian
Peiwen Lian Ph.D
Yantai Yuhuangding Hospital