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The safety and efficacy of umbilical cord mesenchymal stem cell transplantation through femoral artery interventional procedure in spinal cord injury patients
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注册号:

Registration number:

ChiCTR-ONC-12002005 

最近更新日期:

Date of Last Refreshed on:

2015-08-04 

注册时间:

Date of Registration:

2012-03-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脐带间充质干细胞介入移植治疗脊髓损伤的安全性和有效性 

Public title:

The safety and efficacy of umbilical cord mesenchymal stem cell transplantation through femoral artery interventional procedure in spinal cord injury patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脐带间充质干细胞股动脉介入移植治疗脊髓损伤的安全性和有效性 

Scientific title:

The safety and efficacy of umbilical cord mesenchymal stem cell transplantation through femoral artery interventional procedure in spinal cord injury patients 

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:

安沂华 

研究负责人:

安沂华 

Applicant:

Yihua An 

Study leader:

Yihua An 

申请注册联系人电话:

Applicant telephone:

+86 10 57976848 

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 10 57976848 

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:

riveran@163.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:

北京市海淀区永定路69号武警总医院 

研究负责人通讯地址:

北京市海淀区永定路69号武警总医院 

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:

0103122012 

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:

2012-03-12 

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号武警总医院 

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号武警总医院

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:

脊髓损伤 

Target disease:

Spinal cord injury 

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:

描述和分析脐带间充质干细胞股动脉介入移植治疗脊髓损伤的安全性和有效性以及相关影响因素。 

Objectives of Study:

To analyze the safety and efficacy of umbilical cord mesenchymal stem cell transplantation through femoral artery interventional procedure in spinal cord injury patients and other effect 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:

单臂 

Study design:

Single arm 

纳入标准:

1、 脊髓损伤后遗症男性患者,受伤节段在T10—L1。 2、 ASIA美国脊髓损伤协会(2000)评定标准确诊为完全性损伤。 3、 受伤一年以上 

Inclusion criteria

1. the sequelae of spinal cord injury male patients, the injured segment T10-L1; 2. the assessment standards of the American Spinal Injury Association, ASIA (2000) confirmed the complete injury; 3. injured in one year or more. 

排除标准:

排除脊髓空洞形成、局部脊髓受压迫、脊髓栓系、双侧肾盂积水、双侧输尿管积水、泌尿系统结石、高敏体质、肝肾功异常患者。 

Exclusion criteria:

Excluding syringomyelia formation of local spinal cord compression, tethered cord, bilateral hydronephrosis, bilateral hydroureter, urinary stones, the constitution of high sensitivity, liver and kidney function in patients with abnormal. 

研究实施时间:

Study execute time:

From2012-04-01To 2013-12-13 

干预措施:

Interventions:

组别:

1

样本量:

20

Group:

1

Sample size:

干预措施:

股动脉介入干细胞移植

干预措施代码:

Intervention:

umbilical cord mesenchymal stem cell transplantation through femoral artery interventional procedure

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:

尿动力学检查

指标类型:

主要指标 

Outcome:

urodynamic test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

电生理:肢体运动和感觉诱发电位

指标类型:

主要指标 

Outcome:

Electrophysiology: movement and somatosensory evoked potentials

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 18 years
最大 Max age 65 years

性别:

男性

Gender:

Male

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:

所有人员均无盲法。

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 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:

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:

 2012-03-13
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