ChiCTR2100047124 版本V1.0 版本创建时间2022/01/01 20:33:12 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100047124 

最近更新日期：

Date of Last Refreshed on：

 2021-06-08 03:32:21 

注册时间：

Date of Registration：

 2021-06-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

comparing the effects of stem cells, and rehabilitation therapy for the treatment of knee osteoarthritis

Public title：

comparing the effects of stem cells, and rehabilitation therapy for the treatment of knee osteoarthritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

comparing the effects of Human adipose-derived Mesenchymal stem cells, and rehabilitation therapy for the treatment of knee osteoarthritis

Scientific title：

comparing the effects of Human adipose-derived Mesenchymal stem cells, and rehabilitation therapy for the treatment of knee osteoarthritis

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Mohammad Nasb 

研究负责人：

成宏 

Applicant：

Mohammad Nasb 

Study leader：

Cheng Hong 

申请注册联系人电话：

Applicant telephone：

 15527771485

研究负责人电话：

Study leader's
telephone：

+86 15500023752

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 mmn87@yahoo.com

研究负责人电子邮件：

Study leader's E-mail：

 1518975384@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

湖北省武汉市解放大道1095号

研究负责人通讯地址：

湖北省武汉市解放大道1095号

Applicant address：

China,Hubei,Wuhan , Wuchang

Study leader's address：

1095 Jiefang Ave, Qiaokou Qu, Wuhan, China.

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

 430030

申请人所在单位：

华中科技大学同济医学院附属同济医院

Applicant's institution：

Department of Rehabilitation Medicine and Physical Therapy, Tongji Hospital, Huazhong University of Science and Technology, Jiefang Ave, Qiaokou Qu, Wuhan 430030, PR China.

研究负责人所在单位：

华中科技大学同济医学院附属同济医院

Affiliation of the Leader：

Department of Rehabilitation Medicine and Physical Therapy, Tongji Hospital, Huazhong University of Science and Technology

是否获伦理委员会批准：

否

Approved by ethic committee：

No

伦理委员会批件文号：

Approved No. of ethic committee：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Damascus University

Primary sponsor：

Damascus University

研究实施负责（组长）单位地址：

叙利亚Damascus University

Primary sponsor's address：

Damascus University, Damascus, Syria

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北

市(区县)：

武汉

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

华中科技大学同济医学院同济医院

具体地址：

硚口区解放大道1095号

Institution
hospital：

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address：

1095 Jiefang Avenue, Qiaokou District

国家：

叙利亚

省(直辖市)：

大马士革

市(区县)：

Country：

Syria

Province：

Damascus

City：

单位(医院)：

大马士革大学

具体地址：

叙利亚大马士革大马士革大学

Institution
hospital：

Damascus University

Address：

Damascus University, Damascus, Syria

经费或物资来源：

Damascus University research funding

Source(s) of funding：

Damascus University research funding

研究疾病：

Osteoarthritis  

Target disease：

Osteoarthritis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

comparing the effects of stem cells, and rehabilitation therapy for the treatment of knee osteoarthritis  

Objectives of Study：

comparing the effects of stem cells, and rehabilitation therapy for the treatment of knee osteoarthritis

药物成份或治疗方案详述：

Lipogems stem cells preparation protocol 

Description for medicine or protocol of treatment in detail：

Lipogems stem cells preparation protocol 

纳入标准：

1. Males and females aged 18 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;
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 4/10 on a visual analogue scale (VAS).

Inclusion criteria

1. Males and females aged 18 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;
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 4/10 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;
3. The patients who have meniscus injury of knee joint need surgical repair;
4. The patients who have severe coagulation disorders or cardiopulmonary conditions;
5. The women who are pregnant or nursing;
6. There are electronic implants such as pacemakers in the body;
7. The patients who are infected the HIV, the virus of hepatitis or syphilis or Bleeding disorders;
8. The patients with severe cognitive impairment who cannot follow instructions to complete the treatment;
9. History of cancer;
10. Immunodeficiency patients;
11. History of systemic illness or significant organ impairment/failure (i.e., renal failure);
12. The patients who have congenital or acquired knee malformation.

Exclusion criteria：

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;
3. The patients who have meniscus injury of knee joint need surgical repair;
4. The patients who have severe coagulation disorders or cardiopulmonary conditions;
5. The women who are pregnant or nursing;
6. There are electronic implants such as pacemakers in the body;
7. The patients who are infected the HIV, the virus of hepatitis or syphilis or Bleeding disorders;
8. The patients with severe cognitive impairment who cannot follow instructions to complete the treatment;
9. History of cancer;
10. Immunodeficiency patients;
11. History of systemic illness or significant organ impairment/failure (i.e., renal failure);
12. The patients who have congenital or acquired knee malformation.

研究实施时间：

Study execute time：

从 From 2021-07-01 00:00:00至 To 2021-07-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-07-01 00:00:00 至 To 2021-09-01 00:00:00

干预措施：

Interventions：

组别：

1组

样本量：

 35

Group：

1 group

Sample size：

干预措施：

单次关节内注射HADMSCs

干预措施代码：

Intervention：

Single intra-articular injection of HADMSCs

Intervention code：

组别：

2组

样本量：

 35

Group：

2 group

Sample size：

干预措施：

每天进行康复治疗，每周5天，持续8周

干预措施代码：

Intervention：

Rehabilitation therapy daily, five days a week, for up to 8 weeks

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 叙利亚

省(直辖市)：

 大马士革 

市(区县)：

  

Country：

Syria

Province：

Damascus

City：

单位(医院)：

 大马士革大学 

单位级别：

  

Institution
hospital：

Damascus University

Level of the institution：

测量指标：

Outcomes：

指标中文名：

国际膝关节功能评分

指标类型：

主要指标

Outcome：

International Knee Function Score

Type：

Primary indicator

测量时间点：

测量方法：

调查

Measure time point of outcome：

Measure method：

survey

指标中文名：

视觉模拟评分

指标类型：

次要指标

Outcome：

Visual Analogue Scale (VAS)

Type：

Secondary indicator

测量时间点：

测量方法：

调查

Measure time point of outcome：

Measure method：

survey

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

脂肪组织

组织：

脂肪组织

Sample Name：

Adipose tissue

Tissue：

Adipose tissue

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Participants will be randomly allocated to one of the 2 groups in a ratio of 1:1. Patients’ allocations will be according to a randomly generated number using a computerized randomization table (http://www.randomization.com). This table of randomization numbers will be provided only to specified personnel at the st

Randomization Procedure (please state who generates the random number sequence and by what method)：

Participants will be randomly allocated to one of the 2 groups in a ratio of 1:1. Patients’ allocations will be according to a randomly generated number using a computerized randomization table (http://www.randomization.com). This table of randomization numbers will be provided only to specified personnel at the st

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding both participants and healthcare professionals is not feasible in this type of intervention. However, in order to minimize bias, the outcome evaluation will be standardized and done by well-trained investigators. Furthermore, the investigators and evaluators will be blinded to the group/treatment assignment. After completing the study, the statistician will present un-blinded data to the investigators.

Blinding：

Blinding both participants and healthcare professionals is not feasible in this type of intervention. However, in order to minimize bias, the outcome evaluation will be standardized and done by well-trained investigators. Furthermore, the investigators and evaluators will be blinded to the group/treatment assignment. After completing the study, the statistician will present un-blinded data to the investigators.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

The result will be published in a scientific journal

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The result will be published in a scientific journal

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

collected date logged on each patient's CRF

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

collected date logged on each patient's CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-06-08 03:32:21