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Comparative analysis on the curative effect between umbilical cord mesenchymal stem cell transplantation and anti-diabetic treatment
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注册号:

Registration number:

ChiCTR-TRC-12002868 

最近更新日期:

Date of Last Refreshed on:

2015-12-29 

注册时间:

Date of Registration:

2012-12-23 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

脐带间充质干细胞移植与常规抗糖尿病治疗对2型糖尿病的疗效对比分析 

Public title:

Comparative analysis on the curative effect between umbilical cord mesenchymal stem cell transplantation and anti-diabetic treatment 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脐带间充质干细胞移植与常规抗糖尿病治疗对2型糖尿病的疗效对比分析 

Scientific title:

Comparative analysis on the curative effect between umbilical cord mesenchymal stem cell transplantation and anti-diabetic treatment 

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:

刘学彬 

研究负责人:

安沂华 

Applicant:

Xuebin Liu 

Study leader:

Yihua an 

申请注册联系人电话:

Applicant telephone:

+86 010-57976849 

研究负责人电话:

Study leader's telephone:

+86 010-57976848 

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:

liuxb912@163.com 

研究负责人电子邮件:

Study leader's E-mail:

riveran@163.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:

北京海淀区永定路69号 细胞移植科 

研究负责人通讯地址:

北京海淀区永定路69号 细胞移植科 

Applicant address:

Department of Cell transplantation, 69 Yongding Road, Haidian District, Beijing 

Study leader's address:

Department of Cell transplantation, 69 Yongding Road, Haidian District, Beijing 

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:

 

申请人所在单位:

武警总医院 

Applicant's institution:

General Hospital of Chinese People's Armed Police Forces 

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:

09132011 

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:

武警总医院伦理委员会 

Name of the ethic committee:

Ethics committee of General Hospital of Chinese People's Armed Police Forces 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-10-10 

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:

武警总医院 

Primary sponsor:

General Hospital of Chinese People's Armed Police Forces 

研究实施负责(组长)单位地址:

北京海淀区永定路69号 

Primary sponsor's address:

69 Yongding Road, Haidian District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

武警总医院

具体地址:

北京海淀区永定路69号

Institution
hospital:

Armed Police General Hospital

Address:

69 Yongding Road, Haidian District, Beijing

经费或物资来源:

院内课题 

Source(s) of funding:

Armed Police General Hospital Funding 

研究疾病:

2型糖尿病 

Target disease:

Type 2 Diabetes 

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:

II期临床试验 

Study phase:

研究目的:

观察脐带间充质干细胞移植治疗与常规抗糖尿病治疗对2型糖尿病的疗效对比分析 

Objectives of Study:

Comparative analysis on the curative effect between umbilical cord mesenchymal stem cell transplantation and anti-diabetic treatment 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1、年龄在18-70岁,2型糖尿病患者,男女不限; 2、目前现有的抗糖尿病治疗(包括药物和胰岛素)血糖控制不佳已经三个月,无急性并发症倾向; 3、2型糖尿病诊断明确 4、空腹血糖≥7.0 mmol/L ,糖化血红蛋白≥7% 5、心肝肾等脏器功能正常,能耐受介入等手术。 

Inclusion criteria

The inclusion criteria included the following: the patients were between the ages of 18 and 70 years, male or female; they had poor glycemic control with recent anti-diabetic therapies, including drugs and/or insulin injection for at least three months; they had a negative result in testing for the glutamic acid decarboxylase antibody; they had not been pregnant or nursing; they had a fasting blood glucose (FBG) level >=7.0 mmol/L and HbA1c>=7%; and they had a good organic sufficiency, including heart, liver, kidney and lung, to receive interventional therapy. 

排除标准:

1、有急慢性感染;2、有过肿瘤的;3、免疫性疾病;4、妊娠糖尿病;5、心、肝、肾功能不全;6、出血性疾病、凝血异常、造影剂过敏或正在应用抗凝药物;7、其他内分泌及代谢性疾病。 

Exclusion criteria:

acute or chronic infections; any malignancies; hematological diseases or coagulopathy; known immunosuppressive disease (e.g., acquired immunodeficiency); acute or chronic pancreatitis; and a history of thoracic or abdominal aorta diseases 

研究实施时间:

Study execute time:

From2011-06-01To 2013-05-01 

干预措施:

Interventions:

组别:

脐带间充质干细胞移植组

样本量:

30

Group:

A

Sample size:

干预措施:

脐带间充质干细胞移植

干预措施代码:

Intervention:

umbilical cord mesenchymal stem cell transplantation

Intervention code:

组别:

常规抗糖尿病治疗组

样本量:

30

Group:

B

Sample size:

干预措施:

抗糖尿病药物或胰岛素治疗

干预措施代码:

Intervention:

anti-diabetic drugs or insulin injection

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

武警总医院 

单位级别:

三级甲等医院 

Institution
hospital:

General Hospital of Chinese People's Armed Police Forces  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

糖化血红蛋白

指标类型:

主要指标 

Outcome:

Glycated hemoglobin

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肽

指标类型:

主要指标 

Outcome:

C-peptide

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

Glycemia

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

beta细胞功能

指标类型:

主要指标 

Outcome:

Beta-cell function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素和抗糖尿病药物用量

指标类型:

次要指标 

Outcome:

Insulin requirement and oral hypoglycemic drugs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫细胞检测

指标类型:

次要指标 

Outcome:

Immunologic cells tests

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清炎症因子(IL-1β, IL-6, IL-10 and TNF-α)

指标类型:

次要指标 

Outcome:

Inflammatory cytokines (IL-1 beta, IL-6, IL-10 and TNF)

Type:

Secondary 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:

外周血

组织:

静脉血

Sample Name:

blood

Tissue:

venous blood

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:

结束

Completed

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):

随机数值表

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

Random numerical tables

盲法:

NA

Blinding:

NA

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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:

 2012-12-23
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