Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline in visual analogue scale (VAS)
研究概览
简要总结
Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic degenerative disorder. There is no effective therapy available today. This prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30-70 years old.
- •No serious infection, chronic diseases, diabetes and tuberculosis.
- •Osteoarthritis of the knee with grade1-3 defined by the modified Kellgren-Lawrence classification.
- •Written informed consents were obtained from all subjects.
排除标准
- •Pregnant women or cognitively impaired adults.
- •Inflammatory or post infectious arthritis.
- •Intra-articular drug injection within the previous 2 months.
- •Serious medical illness with a life expectancy of less than 1 year.
- •Prior admission for substance abuse.
- •Arthroscopy during the previous 6 months.
- •Systemic autoimmune rheumatic disease.
- •Poorly controlled diabetes mellitus.
- •Immunosuppressive or anticoagulant treatments.
- •Treatment with corticosteroids in the 3 months prior to inclusion in the study.
- •NSAID therapy within 15 days prior to inclusion in the study.
研究组 & 干预措施
Intervention group
Intraarticular injection of 2×10~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml)
干预措施: Umbilical-cord mesenchymal stromal cells (UC-MSCs) (Biological)
Control group
Intraarticular injection of hyaluronic acid
干预措施: Hyaluronic acid (Other)
结局指标
主要结局
Change From Baseline in visual analogue scale (VAS)
时间窗: Baseline, 1, 3, 6 and 12 weeks
Visual analogue scale (VAS)
Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score
时间窗: Baseline, 1, 3, 6 and 12 weeks
WOMAC
Change From Baseline in knee society score (KSS)
时间窗: Baseline, 1, 3, 6 and 12 weeks
knee society score (KSS)
Change From Baseline in MOS item short from health survey(SF-36)
时间窗: Baseline, 1, 3, 6 and 12 weeks
The MOS item short from health survey(SF-36)
次要结局
- The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI(Baseline, 1, 3, 6 and 12 weeks)
- The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid(Baseline, 1, 3, 6 and 12 weeks)