Treatment of Knee Osteoarthritis With Stromal Vascular Fraction Cells: 10-Years Follow-up
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence of treatment related adverse events
研究概览
简要总结
This is an interventional study to treat knees osteoarthritis (KOA) with adipose-derived stromal vascular fraction cell components in sixteen subjects with either unilateral or bilateral symptomatic Kellgren Lawence Grade 3 KOA by intra-articular injection of knees. Later, subjects were followed for safety out and potential benefits.
详细描述
A prospective, open-label interventional study was conducted to assess safety and evidence of clinical response to administration of intra-articular SVF in 16 patients with symptomatic, radiographic Kellgren Lawence grade 3 KOA. Approximately 55.5 million SVF cells were administered via intra-articular injection into each of the 29 knees; asymptomatic knees remained untreated. Subjects were followed for safety out to six months. Potential benefit was measured using the Knee Injury Osteoarthritis Outcome Scores (KOOS) at baseline (pre-treatment), at 3- and 6-months post-treatment, and then subsequently at 10 years.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiologically documented Kellgren Lawence grade 3 (moderate) KOA;
- •Knee pain rated greater than 4/10 on the linear pain scale;
- •Previous treatment history with anti-inflammatory medications or corticosteroid injections
排除标准
- •Corticosteroid injection within 3 months prior to SVF treatment
- •Taking anticoagulants prior to SVF treatment
研究组 & 干预措施
SVF cells treatment
Intra-articular injection of SVF cells in the injured knee.
干预措施: autologous adipose tissue-derived stromal vascular fraction cells (Biological)
结局指标
主要结局
Incidence of treatment related adverse events
时间窗: 6 months follow-up post intervention
Documentation of adverse events
Osteoarthritis outcome score (KOOS)
时间窗: Up to 10 years follow-up post SVF treatment
Changes in KOOS scores
次要结局
未报告次要终点