Autologous Adipose-derived Mesenchymal Stem Cells in the Treatment of Tendon Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks
研究概览
简要总结
This study was a single-center, randomized, single-blind clinical trial. We plan to include 100 patients who met exclusion criteria of rotator cuff and lateral epicondylosis (tennis elbow) respectively by MRT or ultrasonography. The patients will be randomly divided into two groups. Adipose mesenchymal stem cells will be isolated from adipose tissue, cultured and then transplanted back to the tendon injury site by multiple point injection. 1*10^6 cells as an unit. Patients in the experiment group will be injected into an unit of adipose mesenchymal stem cells (1*10^6/10kg) while the control group received the same dose compound betamethasone injection. Follow up visit for all patients will occur at 1，3，6 and 12 months after the first injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.
详细描述
All injection will be done under ultrasound guidance.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 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 or lateral epicondylitis (tennis elbow);
- •symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid;
- •patient that can understand the clinical trials and signed the informed consent.
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 3 months
- •history of drug/alcohol addiction, habitual smoker
研究组 & 干预措施
Autologous adipose-derived MSCs
The dose of adipose-derived mesenchymal stem cells was related to body weight, and 1 × 10 ^ 6 cells were a unit. One unit of adipose-derived mesenchymal stem cells was injected every 10 kg of body weight and injected once a week for three times.
干预措施: Autologous adipose-derived MSCs (Biological)
Compound betamethasone
1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume with the cell suspension (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) ), once a week for three times.
干预措施: Compound betamethasone (Drug)
结局指标
主要结局
Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks
时间窗: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Pain on activity will be evaluated by VAS
次要结局
- Change from baseline in Constant-Murley Score(CMS) at 3, 6 and 12 weeks,(Baseline, 3 weeks, 6 weeks, 12 weeks after intervention)
- American Shoulder and Elbow Surgeons (ASES) Shoulder Score(Baseline, 3 weeks, 6 weeks, 12 weeks after intervention)
- The Disabilities of the Arm, Shoulder and Hand(DASH) Score(Baseline, 3 weeks, 6 weeks, 12 weeks after intervention)
- Adverse events(From baseline through study completion, an average of 1 year)