今天是:2018-12-14 星期五

人脐带间充质干细胞静脉输注治疗难治性弥漫性结缔组织病的疗效及安全性
下载XML文档

注册号:

Registration number:

ChiCTR-OPB-15005956 

最近更新日期:

Date of Last Refreshed on:

2015-02-09 

注册时间:

Date of Registration:

2015-02-09 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

人脐带间充质干细胞静脉输注治疗难治性弥漫性结缔组织病的疗效及安全性 

Public title:

Effective and safety of human umbilical cord derived mesenchymal stem cells (HU - MSCs) infusion treatment of refractory connective tissue diseases 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

人脐带间充质干细胞静脉输注治疗难治性弥漫性结缔组织病的疗效及安全性 

Scientific title:

Effective and safety of human umbilical cord derived mesenchymal stem cells (HU - MSCs) infusion treatment of refractory connective tissue diseases 

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:

钟兵 

研究负责人:

王勇 

Applicant:

Bing Zhong 

Study leader:

Yong Wang 

申请注册联系人电话:

Applicant telephone:

+86 18203063388 

研究负责人电话:

Study leader's telephone:

+86 18983007129 

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:

dune_zhong@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wangyongjhy@126.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:

第三军医大学西南医院风湿免疫科 

研究负责人通讯地址:

第三军医大学西南医院风湿免疫科 

Applicant address:

Department of Rheumatology, Southwest Hospital, Third Military Medical University, Chongqing 

Study leader's address:

Department of Rheumatology, Southwest Hospital, Third Military Medical University, Chongqing 

申请注册联系人邮政编码:

Applicant postcode:

400038 

研究负责人邮政编码:

Study leader's postcode:

400038 

申请人所在单位:

第三军医大学西南医院风湿免疫科 

Applicant's institution:

Department of Rheumatology, Southwest Hospital, Third Military Medical University, Chongqing 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2014年(技)006 

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:

中国人民解放军第三军医大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Third Military Medical University, PLA 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-09-23 

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:

第三军医大学西南医院 

Primary sponsor:

Southwest Hospital, Third Military Medical University 

研究实施负责(组长)单位地址:

重庆市沙坪坝区高滩岩正街29号 

Primary sponsor's address:

No.29 Gaotanyan street, Shapingba direction, Chongqing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

重庆

Country:

China

Province:

ChongQing

City:

ChongQing

单位(医院):

第三军医大学西南医院

具体地址:

重庆市沙坪坝区高滩岩正街29号

Institution
hospital:

Southwest Hospital, Third Military Medical University

Address:

No.29 Gaotanyan street, Shapingba direction, Chongqing

经费或物资来源:

第三军医大学西南医院临床科研基金 

Source(s) of funding:

Clinical research fund of Southwest Hospital, Third Military Medical University 

研究疾病:

弥漫性结缔组织病 

Target disease:

connective tissue diseases 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

II期临床试验 

Study phase:

II (Phase II study) 

研究目的:

评估间充质干细胞治疗难治性结缔组织病的疗效及安全性。 

Objectives of Study:

The puopose of this study was to determine the long-term Effective and safety of mesenchymal stem cell treatment for refractory connective tissue diseases. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

自身前-后对照研究 

Study design:

Before-After control 

纳入标准:

1)自愿作为受试对象,患者签署知情同意书,且能按时随访; 2)年龄16至70岁之间,性别不限;3)符合美国风湿病学会对于类风湿关节炎、系统性红斑狼疮、皮肌炎、多发性肌炎、系统性硬化症、原发性干燥综合征、系统性血管炎等一系列弥漫性结缔组织病分类标准;4)常规治疗方案无效。 

Inclusion criteria

1. Patient has signed informed consent for mesenchymal stem cell treatment and is willing to return for follow-up visits; 2. Age range 18 to 70 years,gender unlimited; 3. Patients with connective tissue diseases, such as rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis/polymyositis, systemic sclerosis, primary sj?gren syndrome or systemic vasculitis; 4. patients were inadequate response for the conventional therapy. 

排除标准:

1)年龄<18岁或>70岁者;2) 妊娠或哺乳期妇女,过敏体质者;3)有严重心、脑、肝、肾、血液、内分泌系统疾病者;4)有意识障碍或精神异常者;5)重度活动性临床感染者;6)已知的HIV感染者或药物成瘾者;7)3个月内参加过其他药物临床实验者;8)因其他原因,研究者认为不宜纳入者。 

Exclusion criteria:

Patients were excluded from this study for any of the following reasons: age <18 years or >70 years; pregnant or lactating, if applicable; known to be allergic to any test medication; serious concomitant cardiac, cerebral, hepatic, renal, hematological or endocrine disorders; impaired consciousness or psychiatric disorders; complicating severely active infection; HIV carrier; drug addiction; participation in any other clinical studies within the previous three months; or other reasons at the discretion of investigators. 

研究实施时间:

Study execute time:

From2014-12-01To 2018-12-31 

干预措施:

Interventions:

组别:

脐带间充质干细胞治疗组

样本量:

30

Group:

HU-MSCs treatment group

Sample size:

干预措施:

脐带间充质干细胞静脉输注

干预措施代码:

Intervention:

HU-MSCs intravenous infusion

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

重庆 

Country:

China 

Province:

Chongqing 

City:

ChongQing 

单位(医院):

第三军医大学西南医院 

单位级别:

三级甲等医院 

Institution
hospital:

Southwest Hospital, Third Military Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血沉

指标类型:

主要指标 

Outcome:

ESR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

主要指标 

Outcome:

CRP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

T细胞亚群计数

指标类型:

主要指标 

Outcome:

T cell subgroup count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫球蛋白

指标类型:

主要指标 

Outcome:

IgG IgM IgA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

DAS28评分

指标类型:

主要指标 

Outcome:

DAS28 score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SLEDAI评分

指标类型:

附加指标 

Outcome:

SLEDAI score

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

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

None

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-02-09
返回列表