NCT03089762已完成1 期
Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- WOMAC (Western Ontario and McMaster Universities Arthritis Index)
研究概览
简要总结
Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients age 50 or older who present with symptomatic primary osteoarthritis of the knee
- •daily pain for the previous 3 months
- •analgesics usage at least once a week
- •less than 30 minutes of morning stiffness
- •WOMAC score of ≤ 75 in the target knee
- •Brandt Radiographic Grading Scale of Osteoarthritis grade 1 and 2
排除标准
- •evidence of secondary knee osteoarthritis
- •severe osteoarthritis (Joint space width - JSW < 2 mm)
- •prior intra articular injections within the previous one year prior to inclusion
- •patients with clinically significant systemic disease
结局指标
主要结局
WOMAC (Western Ontario and McMaster Universities Arthritis Index)
时间窗: 1 year
次要结局
- Six minute walk distance(1 year)
研究者
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