Today is 2018-11-15

Comparing of effect of umbilical cord mesenchymal stem sell therapy on motor function of twin cerebral palsy
download

注册号:

Registration number:

ChiCTR-ONC-12003124 

最近更新日期:

Date of Last Refreshed on:

2016-01-27 

注册时间:

Date of Registration:

2013-03-21 

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对双胞胎脑瘫患儿运动功能影响的对比分析 

Public title:

Comparing of effect of umbilical cord mesenchymal stem sell therapy on motor function of twin cerebral palsy 

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对双胞胎脑瘫患儿运动功能影响的对比分析 

Scientific title:

Comparing of effect of umbilical cord mesenchymal stem sell therapy on motor function of twin cerebral palsy 

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:

王晓东 

研究负责人:

安沂华 

Applicant:

Xiaodong Wang 

Study leader:

Yihua An 

申请注册联系人电话:

Applicant telephone:

+86 010-57976867 

研究负责人电话:

Study leader's telephone:

+86 010-57976867 

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:

xdwang2000@163.com 

研究负责人电子邮件:

Study leader's E-mail:

doctoran2010@hotmail.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, Beijing, China 

Study leader's address:

69 Yongding Road, Haidian District, Beijing, 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:

 

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:

0109212012 

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 

Name of the ethic committee:

General Hospital of Chinese People’s Armed Police Forces 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-09-30 

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, Beijing, China 

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, Beijing, China

经费或物资来源:

无 

Source(s) of funding:

no 

研究疾病:

脑性瘫痪 

Target disease:

cerebal palsy 

研究疾病代码:

G80.901 

Target disease code:

G80.901 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

IV期临床试验 

Study phase:

IV (Phase IV study) 

研究目的:

分析和总结脐带间充质干细胞移植治疗双胎脑瘫患儿的疗效及其影响因素 

Objectives of Study:

To analyze and conclude efficacy of twin cerebral palsy children undergoing umbilical cord mesenchymal stem cells transplantation and the related factors. 

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、1-18岁确诊的小儿脑瘫患者; 2、双胎均罹患脑瘫疾病;3、家属自愿接受干细胞移植并配合随访; 3、签署知情同意书。 

Inclusion criteria

1. Patients with cerebral palsy and aged 1-18 years old; 2. Twins were suffering from cerebral palsy; 3. Parents were able to accept voluntarily stem cell transplantation for their children and followed-up; 4. They signed consent form. 

排除标准:

1、严重过敏性体质,恶性肿瘤及血液系统疾病; 2、血清学检查肝炎、艾滋病、梅毒阳性患者; 3、遗传代谢病。 

Exclusion criteria:

1. severe of allergic constitution, malignant tumor/ hematological disorders; 2. positive serological tests such as AIDS, hepatitis B,C, syphilis etc.; 3. hereditary metabolic diseases of nervous system. 

研究实施时间:

Study execute time:

From2012-10-01To 2013-12-31 

干预措施:

Interventions:

组别:

干细胞移植组

样本量:

20

Group:

stem cell transplantation group

Sample size:

干预措施:

干细胞移植

干预措施代码:

Intervention:

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):

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:

脑瘫粗大运动评价量表

指标类型:

主要指标 

Outcome:

Gross Motor Function Measure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

精细运动功能评估量表

指标类型:

主要指标 

Outcome:

Fine Motor Funetion Measure

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:

no

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 1 years
最大 Max age 18 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):

no

盲法:

Blinding:

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):

中国人民武装警察部队总医院

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

General Hospital of Chinese People’s Armed Police Forces

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:

中国人民武装警察部队总医院

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

General Hospital of Chinese People’s Armed Police Forces

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-03-21
return list