NCT06109220招募中不适用
Clinical Study on the Safety and Efficacy of Intrarticular Injection of Autologous Adipose-derived Vascular Matrix Components (SVF) in the Treatment of Knee Osteoarthritis (KOA)
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- T2 mapping
研究概览
简要总结
The purpose of this study was to analyze and study the efficacy and safety of autologous adipose-derived vascular matrix components (SVF) in patients with knee osteoarthritis before and after treatment through clinical evaluation, radiation index, and metabolic index comparison between plasma and irrigation solution before and after SVF injection.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The age range is 20-70 years old
- •Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower
- •The physical health status is mainly in the ASA grade Ⅰ, Ⅱ and Ⅲ
- •Subjects had no active tumors, no active inflammation, no treponema pallidum, HIV, hepatitis B virus, or hepatitis C virus
- •The subject shall provide the physical examination report of knee X-ray examination, MRI examination and other items
排除标准
- •Patients with nonunion or displaced fractures around defective cartilage
- •Pregnant or lactating women
- •Autoimmune disease
- •Subjects with diabetes (exceptions are patients whose blood sugar levels remain within the normal range and diabetes has not caused other complications)
- •The patients had severe neurological diseases affecting the evaluation of postoperative results
结局指标
主要结局
T2 mapping
时间窗: 24 months after the first SVF injection into the knee cavity
The degree of change of articular cartilage was observed
次要结局
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(24 months after the first SVF injection into the knee cavity)
研究者
研究点 (1)
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