Treatment of Intractable Common Extensor Tendon Injury Using Allogeneic Adipose-derived Mesenchymal Stem Cells (Allo-ASC): a Phase II Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of pain visual analogue scale (VAS) during activity
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of intra-tendon injection of allogeneic adipose-derived mesenchymal stem cells (Allo-ASC) in intractable common extensor tendinosis patients in comparison with a control treatment.
详细描述
A phase II randomized placebo controlled trial will be done with following 3 groups. Each group will have 10 participants, so, the total patients will be 30 people.
- High concentration of Allo-ASC group: stem cell 0.5cc (Total: 10 million cells) + Fibrin glue 0.5cc
- Low concentration of Allo-ASC group: stem cell 0.5cc (Total: 1 million cells) + Fibrin glue 0.5cc
- Placebo Comparator (Fibrin) group: Normal saline 0.5cc + Fibrin glue 0.5cc The investigators will compare the efficacy difference with visual analogue scale (VAS) during activity (primary outcome), VAS at rest, Mayo elbow performance index (MEPI), grip strength, ultrasonographic assessment at baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months after injection. Shear wave elastography (SWE) and magnetic resonance image (MRI) will be done at baseline, 12 weeks, 12 months and 24 months after injection
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed as lateral epicondylosis (tennis elbow)
- •symptom duration is over 12 months
- •pain visual analogue scale (VAS) during activity ≥ 5
- •recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
- •common extensor tendon injury can be observed under ultrasound (hypoechoic lesion) and MRI (hyperintensity or discontinuity)
- •patient that can understand the clinical trials
排除标准
- •patient that underwent other injection such as steroid injection or prolotherapy within 6 weeks
- •patients with following conditions (such as arthritis related to the target lesion, synovitis related to the target lesion, paralysis related to the target lesion, entrapment of related nerve to the target lesion, radiculopathy related to the target lesion, infectious disease, generalized pain syndrome, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or Fibrin Glue, contraindication to MRI)
- •patient that enrolled other clinical trials within 30 days
- •current pregnancy or breast-feeding, planning for pregnancy
- •history of drug/alcohol addiction, habitual smoker
- •operation history of affected elbow
- •previous clinical trial involving stem cell administration
- •other severe medical illness or bleeding tendency
- •size of intramural calcification over 2.0 mm under ultrasound evaluation
研究组 & 干预措施
High concentration of Allo-ASC group
High concentration of Allo-ASC 0.5cc (Total: 10 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
干预措施: High concentration of Allo-ASC (Biological)
High concentration of Allo-ASC group
High concentration of Allo-ASC 0.5cc (Total: 10 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
干预措施: Fibrin glue (Drug)
Low concentration of Allo-ASC group
Low concentration of Allo-ASC 0.5cc (Total: 1 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
干预措施: Low concentration of Allo-ASC (Biological)
Low concentration of Allo-ASC group
Low concentration of Allo-ASC 0.5cc (Total: 1 million cells) & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
干预措施: Fibrin glue (Drug)
Placebo Comparator (Fibrin) group
Normal saline 0.5cc & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
干预措施: Fibrin glue (Drug)
Placebo Comparator (Fibrin) group
Normal saline 0.5cc & Fibrin glue 0.5cc by ultrasonographic guided intra-tendon injection
干预措施: Normal saline (Drug)
结局指标
主要结局
Change of pain visual analogue scale (VAS) during activity
时间窗: baseline and 12 weeks
Self reported pain intensity during activity will be evaluated by visual analogue scale (0 = no pain, 10 = pain as bad as can be).
次要结局
- Change of Mayo elbow performance index (MEPI)(baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months)
- Ultrasonographic assessment(baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months)
- Shear wave elastography(baseline, 12 weeks and 24 months)
- Magnetic resonance image (MRI) assessment(baseline, 12 weeks and 24 months)
- Change of pain visual analogue scale (VAS) during activity(baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months)
- Change of pain visual analogue scale (VAS) at rest(baseline, 6 weeks, 12 weeks, 6 months, 12 months and 24 months)
研究者
Sun Gun Chung
Professor
Seoul National University Hospital