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脐带间充质干细胞移植治疗糖尿病周围神经病变
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注册号:

Registration number:

ChiCTR-OIN-17010524 

最近更新日期:

Date of Last Refreshed on:

2017-01-26 

注册时间:

Date of Registration:

2017-01-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脐带间充质干细胞移植治疗糖尿病周围神经病变 

Public title:

Human umbilical cord mesenchymal stem cell transplantation on diabetic peripheral neuropathy 

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糖尿病周围神经病变的疗效分析 

Scientific title:

Study of effect of human umbilical cord mesenchymal stem cell transplantation on diabetic peripheral neuropathy 

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:

Zheng Pei 

Study leader:

An yihua 

申请注册联系人电话:

Applicant telephone:

+86 15001359498 

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:

zhengyisheng126@126.com 

研究负责人电子邮件:

Study leader's E-mail:

riveran@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:

北京市海淀区永定路69号 

研究负责人通讯地址:

北京市海淀区永定路69号 

Applicant address:

69 Yongding Road, Haidian District, Beiing 

Study leader's address:

69 Yongding Road, Haidian District, Beiing 

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:

中国人民武装警察部队总医院 

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:

12062015 

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:

中国人民武装警察部队总医院医学伦理委员会 

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:

2015-12-06 

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:

中国人民武装警察部队总医院 

Primary sponsor:

General Hospital of Chinese People's Armed Police Forces 

研究实施负责(组长)单位地址:

北京市海淀区永定路69号 

Primary sponsor's address:

69 Yongding Road, Haidian District, Beiing 

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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民武装警察部队总医院

具体地址:

北京市海淀区永定路69号

Institution
hospital:

General Hospital of Chinese people's Armed Police Forces

Address:

69 Yongding Road, Haidian District, Beiing

经费或物资来源:

自筹经费 

Source(s) of funding:

self-prepare 

研究疾病:

糖尿病周围神经病变 

Target disease:

Diabetic Peripheral Neuropathy 

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:

分析脐带间充质干细胞移植对糖尿病周围神经病变的疗效 

Objectives of Study:

To analyze the effect of human umbilical cord mesenchymal stem cell transplantation on diabetic peripheral neuropathy 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

①有明确的糖尿病史。②有四肢末端感觉异常和(或)感觉障碍,膝、跟腱反射减弱或消失;TCSS评分≥6分。神经电生理检查异常。④入选后接受治疗期间和随访的半年内不能应用其它治疗神经病变药物。 

Inclusion criteria

1. Have a clear history of diabetes; 2. sensory dysfunction, knee, Achilles tendon reflexes weaken or disappear TCSS≥6 neurophysiological abnormalities; 3. No other neuropathic drugs can be administered within six months after enrollment and during follow-up. 

排除标准:

排除标准:①近3个月内应用过其它治疗神经病变药物的患者。②有严重下肢溃疡或坏疽,不适合行下肢介入手术者。③恶性肿瘤。④严重的心肝肾疾病。⑤患有可导致周围神经病变的其他疾病。⑥感染未完全控制。 

Exclusion criteria:

1. Nearly 3 months of application of other drugs in patients with neuropathy; 2. Severe leg ulcers or gangrene, not suitable for line lower limb intervention; 3. cancer; 4. Severe heart, liver and kidney disease; 5. Suffering from peripheral neuropathy can lead to other diseases; 6. Infection not fully controlled. 

研究实施时间:

Study execute time:

From2016-03-01To 2017-12-06 

干预措施:

Interventions:

组别:

治疗组

样本量:

40

Group:

case

Sample size:

干预措施:

脐带间充质干细胞

干预措施代码:

Intervention:

hereditary cerebellar ataxia

Intervention code:

组别:

对照组

样本量:

12

Group:

control

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional therapy

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 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民武装警察部队总医院 

单位级别:

三级甲等 

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:

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:

HbA1C levels

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

多伦多临床评分系统

指标类型:

主要指标 

Outcome:

Toronto clinical scoring system

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经电生理

指标类型:

主要指标 

Outcome:

electrophysiological examination

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:

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 30 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):

非随机对照研究

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

non-random study

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):

研究结束后6月按需公开原始数据

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

aw data can be shared within 6 months after the trail complete

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:

原始的数据记录及病例记录表,纸质版由实验负责人保存;电子版采用EXCEL及SPSS格式进行保存

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

All of the original data records and case records, the paper version materials was preserved by experimental operator, and the electronic version records was saved by using EXCEL and SPSS software.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-01-26
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