Autologous Mesenchymal Stem Cell Transplantation for the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in pain density
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of autologous bone marrow-derived mesenchymal stem cells (BMSCs) 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 BMSCs 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 BM-MSCs 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 bone marrow suction 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
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.
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 WOMAC osteoarthritis index.
次要结局
- Change in MOS item short from health survey(SF-36)(From before randomization until 3, 6, and 12 months after treatment start.)
- Cartilage repair(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
Principle Investigator
Yantai Yuhuangding Hospital