Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells(ALLO-ASC):A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks
研究概览
简要总结
Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be administrated to the patients with lateral epicondylitis by ultrasonographic guided injection.
详细描述
Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. First the investigators will administrate 1 million cells/ml (Group 1 for 6 participants). After monitoring the safety of injection for 2 weeks (the investigators will use WHO recommendations for grading of acute and subacute toxic effects), the investigators decide to increase the quantity as 10 million cells/ml (Group 2 for participants).
The investigators will compare the efficacy difference as quantity increase. For efficacy measurement, VAS/modified Mayo clinic performance index for elbow/lesion measurement by ultrasound will be used at 6 and 12 weeks after injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed as lateral epicondylitis (tennis elbow)
- •recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
- •symptom duration is over 6 months
- •defect in common extensor tendon can be observed under ultrasound
- •patient that can understand the clinical trials
排除标准
- •patient that underwent other injection treatment within 6 weeks
- •some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
- •patient that enrolled other clinical trials within 30 days
- •history of drug/alcohol addiction, habitual smoker
结局指标
主要结局
Change From Baseline in Visual Analog Scale (VAS) at 6 and 12 Weeks
时间窗: Baseline, 6 weeks, 12 weeks after intervention
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be), higher scores meaning worse outcome.
次要结局
- Modified Mayo Clinic Performance Index for the Elbow(Baseline, 6 weeks, 12 weeks after the intervention)
- Defect Area of Tendon by Ultrasonography in Long Axis(Baseline, 6 weeks, and 12 weeks after the intervention)
- Defect Area of Tendon by Ultrasonography in Short Axis(Baseline, 6 weeks, and 12 weeks after the intervention)
研究者
Sun Gun Chung
Professor
Seoul National University Hospital