【ChiCTR1900025907】干细胞和低强度脉冲超声联合治疗膝骨关节炎

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基本信息

登记号

ChiCTR1900025907

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

2019-09-14

临床申请受理号

靶点

适应症

骨关节炎

试验通俗题目

干细胞和低强度脉冲超声联合治疗膝骨关节炎

试验专业题目

Human adipose-derived Mesenchymal stem cells, low intensity pulsed ultrasound or their combination for the treatment of knee osteoarthritis

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

430030

联系人通讯地址

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临床试验信息

试验目的

To investigate the potential of low intensity pulsed ultrasound in enhancing the regeneration process of the osteoarthritic knee joint.

试验分类

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试验类型

半随机对照

试验分期

Ⅲ期

随机化

Participants will be randomly allocated to either an Intraarticular stem cells injection with LIPUS, Intraarticular stem cells injection with shame LIPUS, or Normal saline with LIPUS in a ratio of 1:1:1, Patients’ allocation will be according to a random generated number using a computerized randomization Table

盲法

试验项目经费来源

国家自然科学基金

试验范围

目标入组人数

实际入组人数

第一例入组时间

2019-11-01

试验终止时间

2022-09-01

是否属于一致性

入选标准

1. Males or females aged 18 Years to 70 Years old; 2. Radiological diagnosis of osteoarthritis using the American College of Rheumatology criteria; 3. Radiological grading of Grade II–III osteoarthritis (OA) of the knee as determined by a qualified radiologist using the Kellgren and Lawrence system; 4. Medial or lateral compartment OA as determined above; 5. Less than 5 degrees varus or valgus knee deformity as measured by the long mechanical axis of the knee on x-ray; 6. A minimum pain score of equal or greater than 5/10 on a visual analogue scale (VAS).；

排除标准

1. Previous meniscectomy/significant partial meniscectomy or other knee related surgery within the last 12 months; 2. Previous intra-articular injectable therapies within the last 6 months: (1) The patients who have meniscus injury of knee joint need the surgical repair; (2) The patients who have the severe coagulation disorders, cardiopulmonary failure and so on; (3) The women who are pregnant or nursing; (4) There are electronic implants such as pacemakers in the body; (5) The patients who are infected the HIV, the virus of hepatitis or syphilis or Bleeding disorders; (6) The patients with severe cognitive impairment who cannot follow instructions to complete the treatment; (7) History of cancer; (8) Immunodeficiency patients; (9) History of systemic illness or significant organ impairment/failure (i.e., renal failure); (10) The patients who have congenital or acquired knee malformation; (11) Patients or researchers who are participating in other clinical trials believe that other reasons are not appropriate for clinical trials.；

研究者信息

研究负责人姓名

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试验机构

华中科技大学同济医学院附属同济医院

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

430030

联系人通讯地址