今天是:2019-07-21 星期日

修饰人脐血来源的内皮祖细胞外泌体的功能促进糖尿病血管损伤后内皮化及其机制的研究
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注册号:

Registration number:

ChiCTR1900021527 

最近更新日期:

Date of Last Refreshed on:

2019-02-25 

注册时间:

Date of Registration:

2019-02-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

修饰人脐血来源的内皮祖细胞外泌体的功能促进糖尿病血管损伤后内皮化及其机制的研究 

Public title:

Modify the exosomes derived from endothelial progenitor cells to promote vascular repair and accelerates reendothelialization in diabetic rats by enhancing endothelial function 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

修饰人脐血来源的内皮祖细胞外泌体的功能促进糖尿病血管损伤后内皮化及其机制的研究 

Scientific title:

Modify the exosomes derived from endothelial progenitor cells to promote vascular repair and accelerates reendothelialization in diabetic rats by enhancing endothelial function 

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:

赵俊功 

研究负责人:

赵俊功 

Applicant:

Zhao Jungong 

Study leader:

Zhao Jungong 

申请注册联系人电话:

Applicant telephone:

+86 18930177655 

研究负责人电话:

Study leader's telephone:

+86 18930177655 

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:

zhaojungong@sjtu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhaojungong@sjtu.edu.cn 

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:

上海市徐汇区宜山路600号 

研究负责人通讯地址:

上海市徐汇区宜山路600号 

Applicant address:

600 Yishan Road, Xuhui District, Shanghai, China 

Study leader's address:

600 Yishan Road, Xuhui District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海市第六人民医院 

Applicant's institution:

Shanghai 6th People's Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

上海市第六人民医院 

Primary sponsor:

Shanghai 6th People's Hospital 

研究实施负责(组长)单位地址:

徐汇区宜山路800号 

Primary sponsor's address:

600 Yishan Road, Xuhui District, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

上海

Country:

China

Province:

Shanghai

City:

Shanghai

单位(医院):

上海市第六人民医院

具体地址:

徐汇区宜山路800号

Institution
hospital:

Shanghai 6th People's Hospital

Address:

600 Yishan Road, Xuhui District, Shanghai, China

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

Natural Science Foundation of China 

研究疾病:

糖尿病 

Target disease:

Diabetes 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

因内皮化延迟,药物洗脱球囊治疗膝下动脉病变面临挑战。干细胞移植虽然可以促进内皮化,但具有栓塞血管、致瘤及致畸风险。我们的前期研究表明,人脐血来源的内皮祖细胞的外泌体可以促进内皮细胞的迁徙、增殖而加速内皮化。要促进糖尿病血管内皮化还须克服内皮祖细胞数目少、内皮细胞MicroRNA-126含量低而增殖功能障碍的缺点。我们设想通过体外构建高表达CXCR4和MicroRNA-126的外泌体,经静脉注射后定向聚集至血管损伤局部,形成调控SDF-1α/CXCR4轴正反馈回路来实现。本研究应用慢病毒转染脐血来源内皮祖细胞形成的高表达CXCR4和MicroRNA-126的外泌体,通过检测内皮细胞的迁徙和增殖、内皮祖细胞的动员、糖尿病大鼠颈动脉损伤后内皮化的程度,以及血管内皮细胞、外周血以及骨髓的SDF-1α的变化,明确修饰后的外泌体可趋向性聚集至血管损伤局部、促进糖尿病大鼠血管损伤后内皮化的价值和机理。 

Objectives of Study:

Patients with critical limb ischemia are at risk for restenosis and complications arising from infrapopliteal arterial revascularization with drug-eluting device. Endothelial progenitor cells (EPCs) transplantation can reduce restenosis by promoting re-endothelialization but it is challenged by microvascular thrombus and potential inducing neoplasm. Our previous study indicated that exosomes derived from EPCs accelerated re-endothelialization by enhancing endothelial function. In order to promote diabetic endothelia cell repair, we should solve the problems of less circulating EPCs and the impaired regenerative capacity of endothelial cells. We hypothesized that exosomes with over- expression of both CXCR4 and mircroRNA-126 could accelerate re-endothelialization by enhancing the migration and proliferation of endothelial cells and mobilization of EPCs as well. In this study, lentiviral vectors with over expressing mircroRNA-126 and CXCR4 were transfected to human umbilical cord blood endothelial progenitor cells, and their exosoms with over- expression of both CXCR4 and mircroRNA-126 were extracted,purifed and obtained. Subsequently, the effects of exosomes on vascular endothelial cells (including migration and proliferation) both under normal glucose and high glucose were investigated in vitro after the exosomes treatment. In addition, induction of the endothelial injury was performed in the diabetic rats carotid artery, and the pro-re-endothelialization as well as number of EPCs derived from peripheral blood after exosomes treatment were measured. Finally, SDF-1αlevel in the supernatant EPC cultures, blood and vascular injury areas were assessed to find out whether exosoms with overexpression of both CXCR4 and mircroRNA-126 can promote re-endothelialization by establishing an self-amplifying feedback loop of the SDF-1α/CXCR4 axis. 

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:

来我院就诊的产妇常规签署《临床标本知情同意书》,上述签署《临床标本知情同意书》的患者均入组。 

Inclusion criteria

Puerperant agreed to sign Informed Consent of Clinical Specimens 

排除标准:

No 

Exclusion criteria:

No 

研究实施时间:

Study execute time:

From2019-03-01To 2020-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

50

Group:

Case series

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

上海 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海市第六人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shanghai 6th People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

N/A

指标类型:

主要指标 

Outcome:

N/A

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:

标本中文名:

脐带血

组织:

Sample Name:

Cord blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 40 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/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):

https://www.ncbi.nlm.nih.gov/

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

https://www.ncbi.nlm.nih.gov/

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:

N/A

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

N/A

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-02-25
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