Evaluation of the Autologous Stromal Vascular Fraction Therapy for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Radiologic evaluation of knee articular cartilage Volume
研究概览
简要总结
The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration.
详细描述
Study participants voluntarily provided written informed consent to participate in the study. The two knees of each patient were randomly assigned to autologous SVF treatment group or non-treatment control group. The patients were evaluated every 4 weeks for safety and efficacy of autologous SVF therapy for 24 weeks.
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
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of Knee Osteoarthritis
- •Articular cartilage defect grades I/II of both knee
排除标准
- •autoimmune or inflammatory arthritis
- •serious medical disorders
结局指标
主要结局
Radiologic evaluation of knee articular cartilage Volume
时间窗: Change from Baseline articular cartilage Volume at 24 weeks
The Volume (cubic millimeter) of knee articular cartilage are measured.
Knee pain evaluation and functional evaluation (The Lysholm Knee Scoring Scale)
时间窗: Change from Baseline Lysholm Knee Scale score at 12 weeks.
The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome.
Radiologic evaluation of knee articular cartilage Area
时间窗: Change from Baseline articular cartilage Area at 24 weeks
The Area (square millimeter) of knee articular cartilage are measured.
Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])
时间窗: Change from Baseline WOMAC arthritis index score at 24 weeks.
Knee pain and functional mobility were assessed using WOMAC arthritis index patient questionnaire including 24 parameters for pain, stiffness and physical function. The values ranging from 0 (minimum) to 240 (maximum) and the lower scores mean a better outcome.
Knee pain evaluation and functional evaluation (The Lysholm Knee Scale)
时间窗: Change from Baseline Lysholm Knee Scale score at 24 weeks.
The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome.
Radiologic evaluation of knee articular cartilage Thickness
时间窗: Change from Baseline articular cartilage Thickness at 24 weeks
The Thickness (millimeter) of knee articular cartilage are measured.
次要结局
未报告次要终点