Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells: Phase II Double-Blind Placebo-Controlled Randomized Clinical Trials.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change of Pain During Activity From Baseline to 3 Months After Intervention
研究概览
简要总结
Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with supraspinatus partial thickness tear 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. Double blind Randomized placebo controlled study will be done with following 3 groups. Each group will have 8 people, so, the total patients will be 24 people.
- Stem cell treatment group : stem cell 0.5cc (Total: 10 million cells) + Fibrin glue 0.5cc + range of motion exercise
- Active control (fibrin glue) group : Normal saline 0.5cc + Fibrin glue 0.5cc + range of motion exercise
- Control (normal saline) group : Normal saline 0.5cc + Normal saline 0.5cc + range of motion exercise
The investigators will compare the efficacy difference with VAS(visual analog scale, primary outcome), ASES(American Shoulder and Elbow Surgeons) Score, UCLA(University of California, Los Angles) Shoulder Score, DASH(The Disabilities of the Arm, Shoulder and Hand) Score and change of tear size compared to the baseline image assessed by MRI. These measurement will be done at 6 and 12 weeks after injections and long-term follow-up will be also planned to 6 months, 12months and 24 months except for the evaluation of the tear size which will be done at baseline, 3 months and 24 months after the intervention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 rotator cuff tear (supraspinatus partial thickness tear)
- •recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
- •symptom duration is over 3 months
- •supraspinatus partial thickness tear proven ultrasonography and magnetic resonance image(MRI)
- •patient that can understand the clinical trials
排除标准
- •patient that underwent other injection treatment within 6 weeks
- •some associated diseases (adhesive capsulitis, full thickness supraspinatus tear,. arthritis of related joint to the target lesion, muscle weakness or atrophy, innervated by suprascapular nerve, paralysis of related joint to target lesion, proximal humeral fracture, infectious disease, bilateral rotator cuff tear, generalized pain syndrome, radiculopathy, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue and contraindication to MRI
- •patient that enrolled other clinical trials within 30 days
- •history of drug/alcohol addiction, habitual smoker, operation, allergic reaction to fibrin glue, local anesthetics and bovine-derived proteins and severe medical disease.
结局指标
主要结局
Change of Pain During Activity From Baseline to 3 Months After Intervention
时间窗: Baseline and 3 months after intervention
Pain during activity will be evaluated by visual analog scale (active pain VAS). The active pain visual analog scale change from baseline to 3 months after intervention is the primary outcome. Visual analog scale is scored 0 to 10, higher scored meaning worse outcome. Negative values in change of pain during activity indicate improvement in pain.
次要结局
- Pain During Activity(Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention)
- American Shoulder and Elbow Surgeons (ASES) Shoulder Score(Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention)
- University of California, Los Angeles(UCLA) Shoulder Score(Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention)
- Tear Size at 3 Months After Injection(baseline and 3 months after intervention)
- Pain During Rest(Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention)
- Disability of Arm, Shoulder and Hand (DASH) Score(Baseline, 6 weeks, 12 weeks, 6, 12, 24 months after intervention)
- Tear Size at 12 Months After Injection(baseline and12 months after intervention)
研究者
Sun Gun Chung
Professor
Seoul National University Hospital