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Effect of Bone Marrow Mesenchymal Stem Cell transplantation in Children with Spinal cord injury without fracture.
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注册号:

Registration number:

ChiCTR-TCH-11001421 

最近更新日期:

Date of Last Refreshed on:

2015-07-12 

注册时间:

Date of Registration:

2011-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

骨髓间充质干细胞移植治疗无骨折脊髓损伤儿童的疗效分析 

Public title:

Effect of Bone Marrow Mesenchymal Stem Cell transplantation in Children with Spinal cord injury without fracture. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

骨髓间充质干细胞移植治疗无骨折脊髓损伤儿童的疗效分析 

Scientific title:

Effect of Bone Marrow Mesenchymal Stem Cell transplantation in Children with Spinal cord injury without fracture. 

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 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:

doctoran2000@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):

doctoran2000@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:

07012011 

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:

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

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:

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:

Chinese people's Armed Police Forces 

研究疾病:

无骨折脊髓损伤 

Target disease:

Spinal cord injury without fracture 

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:

分析骨髓间充质干细胞移植治疗无骨折脊髓损伤儿童的疗效及其影响因素 

Objectives of Study:

To analyze the effect of Bone Marrow Mesenchymal Stem Cell transplantation in Children with Spinal cord injury without fracture. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1.临床表现为脊髓损伤 2.影像学检查无脊椎骨折 

Inclusion criteria

1. The clinical manifestations of spinal cord injury; 2. Without vertebrate fractures on imageology 

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)遗传代谢病;(4)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. Hereditary metabolic diseases of nervous system; 4. Tumor or Hematological diseases. 

研究实施时间:

Study execute time:

From2011-08-01To 2012-12-30 

干预措施:

Interventions:

组别:

无骨折脊髓损伤患者治疗组

样本量:

10

Group:

A

Sample size:

干预措施:

骨髓间充质干细胞移植治疗

干预措施代码:

Intervention:

Stem cell transplantation

Intervention code:

组别:

有骨折脊髓损伤患者治疗组

样本量:

10

Group:

B

Sample size:

干预措施:

骨髓间充质干细胞移植治疗

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:

电生理检查

指标类型:

主要指标 

Outcome:

FIM score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

FIM评分

指标类型:

次要指标 

Outcome:

Electrophysiology

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 2 years
最大 Max age 17 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:

研究人员及患者 否 功能测评者: 盲

Blinding:

Doctor and patients were not blind. Eveluator was blnd

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 peoples 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:

 2011-07-12
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