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Clinical observation on the therapeutic effect of bone marrow mesenchymal stem cell on patients with spinal cord injury
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注册号:

Registration number:

ChiCTR-ONRC-12002478 

最近更新日期:

Date of Last Refreshed on:

2015-09-05 

注册时间:

Date of Registration:

2012-09-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

骨髓间充质细胞移植治疗完全性陈旧性颈髓损伤临床疗效观察 

Public title:

Clinical observation on the therapeutic effect of bone marrow mesenchymal stem cell on patients with spinal cord injury 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

骨髓间充质细胞移植治疗完全性陈旧性颈髓损伤临床疗效观察 

Scientific title:

Clinical observation on the therapeutic effect of bone marrow mesenchymal stem cell on patients with spinal cord injury 

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:

代广辉 

研究负责人:

代广辉 

Applicant:

Dai Guanghui 

Study leader:

Dai Guanghui 

申请注册联系人电话:

Applicant telephone:

+86 10 57976849 

研究负责人电话:

Study leader's telephone:

+86 10 57976849 

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:

daig74@126.com 

研究负责人电子邮件:

Study leader's E-mail:

daig74@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, 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:

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:

06132008 

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:

北京军区总医院伦理委员会 

Name of the ethic committee:

Ethics committee of Beijing Command General Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2009-07-01 

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:

北京军区总医院 

Primary sponsor:

Beijing Command General Hospital 

研究实施负责(组长)单位地址:

北京市东城区南门仓5号 

Primary sponsor's address:

5 Nanmenchang, Dongcheng District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

NA 

Source(s) of funding:

NA 

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:

探讨自体骨髓间充质干细胞(BMMSC)移植治疗完全性陈旧性颈髓损伤的临床疗效 

Objectives of Study:

To explore the therapeutic effect of bome marrow mesenchymal stem cell on old complete injury of cervical spinal cord 

药物成份或治疗方案详述:

NA 

Description for medicine or protocol of treatment in detail:

NA 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

⑴完全性陈旧性颈髓损伤,损伤后/术后病程一年以上; ⑵损伤部位为颈髓4-6; ⑶年龄20-60岁,男女不限。 

Inclusion criteria

1. Clear diagnosis of old complete injury of cervical spinal cord and the duration of patients is more than one year; 2. the damage location is C4-6; 3. The age is from 20 to 60. Male and female both are allowed. 

排除标准:

⑴不完全性脊髓损伤;⑵神经功能仍有恢复趋势;⑶损伤部位存在粘连情况,需要外科手术干预;⑷损伤部位存在明显压迫性病变需要外科手术干预;⑸不明原因神经功能进行性减退;⑹合并脊髓空洞、脊髓或硬脊膜血管畸形等需要外科干预性疾病;⑺拟手术部位有炎症或皮肤破溃;⑻伴出血倾向或凝血功能障碍;⑼全身情况差或全身其它脏器功能障碍不能耐受手术。 

Exclusion criteria:

The following circumstances were also excluded: 1. patients with incomplete SCI; 2. patients who still showed recovery trends in terms of nerve function; 3. patients with adhesions at the injury site that required surgical intervention; 4. patients with significant compressive lesions at the injury site that required surgical intervention; 5. patients with progressive loss of nerve function for unknown reasons; 6. patients with associated syringomyelia, spinal cord or epidural vascular malformations who required surgical intervention; 7. inflammation or skin ulceration at the surgical site; 8. patients with a bleeding tendency or coagulation defects; 9. patients in poor general condition who could not tolerate surgery. 

研究实施时间:

Study execute time:

From2008-01-21To 2010-12-01 

干预措施:

Interventions:

组别:

A

样本量:

20

Group:

A

Sample size:

干预措施:

手术切开治疗

干预措施代码:

Intervention:

open surgical transplantation

Intervention code:

组别:

B

样本量:

20

Group:

B

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

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):

北京军区总医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Command General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

武警总医院 

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:

AIS分级

指标类型:

主要指标 

Outcome:

AIS grading scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ASIA 评分

指标类型:

主要指标 

Outcome:

ASIA 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:

膀胱残余尿

指标类型:

次要指标 

Outcome:

bladder residual urine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌电图

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:

椎旁躯体感觉诱发电位

指标类型:

次要指标 

Outcome:

paravetebral somatosensory evoked potential

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 22 years
最大 Max age 54 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):

NA

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

NA

盲法:

NA

Blinding:

NA

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):

北京军区总医院

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

Beijing Command General Hospital

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:

北京军区总医院

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

Beijing Command General Hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-09-01
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