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Umbilical cord mesenchymal stem cell transplantation for treatment of type 1 diabetes
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注册号:

Registration number:

ChiCTR-TNC-10000986 

最近更新日期:

Date of Last Refreshed on:

2015-06-17 

注册时间:

Date of Registration:

2010-08-03 

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治疗1型糖尿病 

Public title:

Umbilical cord mesenchymal stem cell transplantation for treatment of type 1 diabetes 

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治疗1型糖尿病 

Scientific title:

Umbilical cord mesenchymal stem cell transplantation for treatment of type 1 diabetes 

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:

郑培 

研究负责人:

安沂华 

Applicant:

Pei Zheng 

Study leader:

Yihua An 

申请注册联系人电话:

Applicant telephone:

+86 010 88276849 

研究负责人电话:

Study leader's telephone:

+86 010 88276849 

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:

zhengpei126@126.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 神经干细胞移植科 

研究负责人通讯地址:

北京海淀区永定路69号 神经干细胞移植科 

Applicant address:

Neural stem cell transplantation Division, 69 Yongding Road, Haidian District, Beijing 

Study leader's address:

Neural stem cell transplantation Division, 69 Yongding Road, Haidian District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100039 

研究负责人邮政编码:

Study leader's postcode:

100039 

申请人所在单位:

武警总医院 

Applicant's institution:

Armed Police General Hospital 

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:

2010507 

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:

Armed Police General Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2010-05-06 

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:

Armed Police General Hospital 

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):

Country:

China

Province:

Beijing

City:

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:

NA 

Source(s) of funding:

NA 

研究疾病:

1型糖尿病 

Target disease:

type 1 diabetes 

研究疾病代码:

E10 

Target disease code:

E10 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

观察分析脐带间充质干细胞移植治疗1型糖尿病的疗效 

Objectives of Study:

To analyze the effect of umbilical cord mesenchymal stem cell transplantation in type 2 diabetes patient 

药物成份或治疗方案详述:

①年龄在5-70岁,初发的1型和2型糖尿病患者;②对目前治疗的血糖控制情况不满意,无急性并发症倾向;③心、肝、肾功能较好,能耐受血管内介入治疗手术者。 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

①年龄在5-70岁,初发的1型和2型糖尿病患者;②对目前治疗的血糖控制情况不满意,无急性并发症倾向;③心、肝、肾功能较好,能耐受血管内介入治疗手术者。 

Inclusion criteria

1. primary type1 diabetes aged 5-70 years; 2. the current treatment are not satisfied and no acute complications tendency; 3. be able to tolerate intravascular intervention surgery. 

排除标准:

①恶性肿瘤;②严重心脏病或高血压;③急、慢性肾功能不全或肝功能衰竭;④严重哮喘或其他严重呼吸功能不全;⑤出血性疾病、凝血异常、造影剂过敏或正在应用抗凝药物;⑥先天性或获得性免疫缺陷疾病;⑦其他内分泌及代谢性疾病。 

Exclusion criteria:

1. cancer; 2. serious heart disease or hypertension; 3. acute and chronic renal insufficiency or liver failure; 4. severe asthma or other severe respiratory insufficiency; 5. hemorrhagic disease, coagulopathy, contrast agent allergy or are being applied anticoagulant drugs; 6. congenital or acquired immunodeficiency diseases; 7. other endocrine and metabolic diseases. 

研究实施时间:

Study execute time:

From2010-05-01To 2011-05-01 

干预措施:

Interventions:

组别:

治疗组

样本量:

20

Group:

treatment

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:

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 

Institution
hospital:

Armed Police General Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

胰岛功能

指标类型:

主要指标 

Outcome:

Islet 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:

血糖

指标类型:

主要指标 

Outcome:

Blood sugar

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 5 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):

NA

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

NA

盲法:

研究对象 否

Blinding:

object: not

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):

武警总医院

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

Armed Police General Hospital

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:

武警总医院

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

Armed Police General Hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-08-03
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