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Study of effect of Umbilical cord Mesenchymal Stem Cell of Children with spinal muscular atrophy
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注册号:

Registration number:

ChiCTR-ONC-11001420 

最近更新日期:

Date of Last Refreshed on:

2015-07-12 

注册时间:

Date of Registration:

2011-07-11 

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脊肌萎缩症的疗效分析 

Public title:

Study of effect of Umbilical cord Mesenchymal Stem Cell of Children with spinal muscular atrophy 

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脊肌萎缩症的疗效分析 

Scientific title:

Study of effect of Umbilical cord Mesenchymal Stem Cell of Children with spinal muscular atrophy 

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, 滑蓉蓉 

研究负责人:

安沂华 

Applicant:

Xiaodong Wang, Rongrong Hua 

Study leader:

Yihua An 

申请注册联系人电话:

Applicant telephone:

+86 13641015688 

研究负责人电话:

Study leader's telephone:

+86 10 57976848 

申请注册联系人传真 :

Applicant Fax:

+86 13641015688 

研究负责人传真:

Study leader's fax:

+86 10 57976848 

申请注册联系人电子邮件:

Applicant E-mail:

xdwang2000@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

doctoran@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

xdwang2000@gmail.com 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

doctoran@hotmail.com 

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 

Study leader's address:

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:

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:

07112011 

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:

2011-07-01 

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 

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):

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, Beijing

经费或物资来源:

中国人民武装警察部队总医院 

Source(s) of funding:

General Hospital of Chinese people's Armed Police Forces 

研究疾病:

脊肌萎缩症 

Target disease:

spinal muscular atrophy 

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:

研究目的:

探讨脐带间充质干细胞移植对脊肌萎缩症患儿运动功能的影响 

Objectives of Study:

To study the effect of Umbilical cord mesenchymal stem cell on motor function of Children with spinal muscular atrophy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

To study the effect of Umbilical cord mesenchymal stem cell on motor function of Children with spinal muscular atrophy. 

Inclusion criteria

1. Signed informed consent document; 2. Patients with spinal muscular atrophy were aged between 1 months to 18 years old; 3. Their parents accepted voluntarily stem cell transplantation for their children and followed-up. 

排除标准:

(1)高度过敏体质或者有严重过敏史者; (2)血清学检查如艾滋病、乙肝、梅毒阳性者等;(3)肿瘤或造血系统疾病病史。 

Exclusion criteria:

1. Have a history of severe allergic; 2. Serological tests such as AIDS, hepatitis B, syphilis, etc; 3. Tumor or Hematological diseases. 

研究实施时间:

Study execute time:

From2011-07-01To 2013-06-01 

干预措施:

Interventions:

组别:

干细胞移植治疗

样本量:

10

Group:

stem cell transplantataion

Sample size:

干预措施:

干细胞移植治疗

干预措施代码:

Intervention:

stem cell transplantataion

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:

三甲 

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:

步态分析

指标类型:

主要指标 

Outcome:

gait analysi

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

GMFM

指标类型:

次要指标 

Outcome:

GMFM

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

GMFM

指标类型:

次要指标 

Outcome:

GMFM

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

GMFM

指标类型:

次要指标 

Outcome:

Electromyography

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

GMFM

指标类型:

次要指标 

Outcome:

Electromyograph

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:

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 7 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):

方便选择

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

convenience enrollment

盲法:

试验者:不盲; 受试者:不盲; 功能测评者:盲。

Blinding:

Doctor:no Patient:no Evaluator: blind

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 peoples 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:

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:

 2011-07-11
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