Today is 2019-10-22

Efficacy and safety of local stem cell transplantation for sequelae of spinal cord injury
download

注册号:

Registration number:

ChiCTR-TNRC-12002477 

最近更新日期:

Date of Last Refreshed on:

2015-09-05 

注册时间:

Date of Registration:

2014-09-21 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

局部干细胞移植治疗脊髓损伤的有效性和安全性 

Public title:

Efficacy and safety of local stem cell transplantation for sequelae of spinal cord injury 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

局部干细胞移植治疗脊髓损伤的有效性和安全性 

Scientific title:

Efficacy and safety of local stem cell transplantation for sequelae of 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:

安沂华 

Applicant:

Guanghui Dai 

Study leader:

Yihua An 

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 10-57976848 

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:

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 

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:

01132011 

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:

2011-01-03 

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, China

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:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

I期+II期 

Study phase:

1-2 

研究目的:

比较开放性手术探查加脊髓损伤局部干细胞移植(简称开放性手术移植)和CT引导下脊髓损伤局部穿刺干细胞移植(简称CT引导下移植)两种移植方案的临床疗效及优缺点,探讨后一种方式在临床应用的可能性。 

Objectives of Study:

This study compared the clinical efficacies, advantages and disadvantages of two transplantation approaches for treating spinal cord injury: open surgical exploration combined with local stem cell transplantation (referred to as open surgical transplantation) and local stem cell transplantation by CT-guided puncture (referred to as CT-guided transplantation). 

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:

明确诊断脊髓损伤,病程大于1年。 

Inclusion criteria

Clear diagnosis of spinal cord injury and the duration of patients is more than one year. 

排除标准:

A组(切开治疗组):行开放性手术移植,需除外以下禁忌症:⑴手术部位有炎症或皮肤破溃者;⑵有出血倾向或伴有凝血功能障碍者;⑶全身情况差不能耐受手术者;⑷全身其它脏器功能障碍不能耐受手术者。为了尽量避免其它能影响神经功能康复的因素对干细胞移植疗效评估的影响,A组需要排除以下情况:⑴不完全性脊髓损伤者;⑵神经功能仍有恢复趋势者;⑶损伤部位存在粘连情况,需要外科手术干预者;⑷损伤部位存在明显压迫性病变,需要外科手术干预者;⑸神经功能进行性减退,原因不明者;⑹合并脊髓空洞,需要外科手术干预者;⑺合并脊髓或硬脊膜血管畸形,需要外科手术干预者。排除上述情况后,对患者行静脉复合麻醉,俯卧位,后正中入路完全暴露脊髓损伤部位,并向近端及远端各延长一个椎体,咬除棘突及椎板直至显露正常脊髓,显微镜下后正中切开硬脊膜,将预制好的细胞悬液分别注入临近损伤部位的两侧正常脊髓内(正常与异常脊髓组织交界处),严密缝合硬脊膜并常规关闭切口。术后患者平卧位,卧硬板床,固定保护手术部位,轴位翻身,保持三周。三周后进行康复锻炼。 B组(干细胞移植组):行CT引导下移植,需除外以下禁忌症:⑴不完全性脊髓损伤者;⑵神经功能仍有恢复趋势者;⑶损伤部位存在粘连情况,需要外科手术干预者;⑷损伤部位存在明显压迫性病变,需要外科手术干预者;⑸神经功能进行性减退,原因不明者;⑹合并脊髓空洞,需要外科手术干预者;⑺合并脊髓或硬脊膜血管畸形,需要外科手术干预者;⑻不能俯卧位或俯卧位坚持时间少于30分钟者。 

Exclusion criteria:

For Group A patients, the exclusion criteria included the following: (1) inflammation or skin ulceration at the surgical site; (2) patients with a bleeding tendency or coagulation defects; (3) patients in poor general condition who could not tolerate surgery and (4) patients with systemic organ dysfunction who could not tolerate surgery. To minimize the influence of other factors that could also affect neurological rehabilitation during the assessment of the efficacy of SC transplantation, the following circumstances were also excluded from Group A: (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 who required surgical intervention and (7) patients with associated spinal cord or epidural vascular malformations that required surgical intervention. For Group B patients, the exclusion criteria included the following: (1) patients with incomplete spinal cord injuries; (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 that required surgical intervention; (7) patients with associated spinal cord or epidural vascular malformations that required surgical intervention and (8) patients who could not be in the prone position or who could not remain in the prone position for more than 30 minutes. 

研究实施时间:

Study execute time:

From2011-02-01To 2012-02-09 

干预措施:

Interventions:

组别:

A

样本量:

9

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:

9

Group:

B

Sample size:

干预措施:

CT引导干细胞移植

干预措施代码:

Intervention:

local stem cell transplantation by CT-guided punct

Intervention code:

组别:

C

样本量:

9

Group:

C

Sample size:

干预措施:

康复

干预措施代码:

Intervention:

Rehabilitation therapy

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:

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:

运动诱发电位

指标类型:

次要指标 

Outcome:

ME

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 24 years
最大 Max age 52 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):

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:

 2014-09-21
return list