NCT02544802已完成1 期
Treatment of Primary Osteoarthritis of the Knee Joint With Autologous Mesenchymal Stem Cells
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees.
研究概览
简要总结
The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray.
- •Subject's pain score is 8-13 points (Lequesne's index).
- •Ages between 50-70 years.
- •Signed informed consent from the subject.
- •Female subjects should be post-menopausal women
排除标准
- •Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV.
- •Subject not suitable for liposuction surgery.
- •Subject with hypersensitivity/allergy to anesthetic.
- •Subject's creatinine values higher than 1.6mg/dl.
- •Subject with body mass index, BMI over
- •Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
- •Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
- •Subject enrolled in any other cell therapy studies within the past 30 days.
- •Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
- •Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
- •Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.
研究组 & 干预措施
ADMSCs
Experimental
Three intra-articular injections of ADMSCs at the dose of 8~10x10^6 cells/injection
干预措施: Adipose-Derived Mesenchymal Stem Cells (Drug)
结局指标
主要结局
Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees.
时间窗: 12 months
次要结局
- Clinical imaging assessment of knee X-ray(12 months)
- Clinical assessment of Short Form 36 questionnaire (SF-36)(12 months)
- Clinical imaging assessment of MRI of the knee(12 months)
- Clinical assessment of visual analogue scale (VAS)(12 months)
- Clinical assessment of Hospital for Special Surgery (HSS) Knee Score(12 months)
- Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC)(12 months)
研究者
研究点 (1)
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