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【ChiCTR-IOR-15006942】比較膝關節内注射間充質幹細胞及透明質酸用於治療膝關節炎的效用

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基本信息

登记号

ChiCTR-IOR-15006942

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2015-08-20

临床申请受理号

靶点

适应症

Degenerative osteoarthritis of the knee

试验通俗题目

比較膝關節内注射間充質幹細胞及透明質酸用於治療膝關節炎的效用

试验专业题目

比較膝關節内注射間充質幹細胞及透明質酸用於治療膝關節炎的效用

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

联系人通讯地址

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临床试验信息

试验目的

比較膝關節内注射間充質幹細胞及透明質酸用於治療膝關節炎的效用

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Randomized

盲法

试验项目经费来源

The Chinese University of Hong Kong

试验范围

目标入组人数

实际入组人数

第一例入组时间

1990-01-01

试验终止时间

1990-01-01

是否属于一致性

入选标准

Patients must comply with all the following criteria in order to be included in the study 1. Male and female subjects aged between 18 and < 65; 2. All patients must provide their written consent; 3. All patients must be affected by primary osteoarthritis of the knee (according to ACR - American College of Rheumatology - classification); In case a patient shows a bilateral OA, it will be included and treated for both knees; 4. All patients must have pain symptoms since at least 2 months; 5. All patients must experience, during the inclusion visit (T0), a pain level higher than or equal to 5.0 cm on a VAS scale of 10 cm; 6.All patients should have at least 8 years of school education; 7.Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 and 3.；

排除标准

The presence of one or more of the following criteria will exclude the patient from the study: 1. Patients with previous cases of alcoholism or drug abuse; 2. Pregnancy and breast-feeding; 3. Presence of serious pathologies; 4. Hypersensitivity towards hyaluronic acid; 5. Intra-articular infiltrations of hyaluronic acid or steroids that are in the process of being administered or that have been interrupted since less than 3 months; 6. Steroid-based systemic therapy in progress or interrupted since less than 1 month and/or anti-clotting drugs; 7. History of fractures and/or severe traumas of the knee bone; 8. Significant hematologic diseases; 9. Non-consenting patients who have not provided the written Informed Consent; 10. Mechanical instability, ligamentous laxity/deficiency and gross deformity; 11. Isolated meniscal tear without evident of osteoarthritis.；

研究者信息

研究负责人姓名

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试验机构

Prof. Kevin HO Ki Wai

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

联系人通讯地址

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