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A study for the key technology of mesenchymal stem cells exosomes atomization in the treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030261 

最近更新日期:

Date of Last Refreshed on:

2020-02-26 

注册时间:

Date of Registration:

2020-02-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

间充质干细胞外泌体雾化吸入治疗新型冠状病毒肺炎(COVID-19)的关键技术研究 

Public title:

A study for the key technology of mesenchymal stem cells exosomes atomization in the treatment of novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

间充质干细胞外泌体雾化吸入治疗新型冠状病毒肺炎(COVID-19)的关键技术研究 

Scientific title:

A study for the key technology of mesenchymal stem cells exosomes atomization in the treatment of novel coronavirus pneumonia (COVID-19) 

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:

陈义钢 

研究负责人:

储美萍 

Applicant:

Yigang Chen 

Study leader:

Meiping Chu 

申请注册联系人电话:

Applicant telephone:

+86 13506187399 

研究负责人电话:

Study leader's telephone:

+86 15052103816 

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:

imyigang@126.com 

研究负责人电子邮件:

Study leader's E-mail:

chump1981@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:

无锡市中山路68号 

研究负责人通讯地址:

无锡市广瑞路1215号 

Applicant address:

68 Zhongshan Road, Wuxi, Jiangsu, China 

Study leader's address:

1215 Guangrui Road, Wuxi, Jiangsu, 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:

无锡市第二人民医院 

Applicant's institution:

Wuxi Second People's Hospital 

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:

2020-003-1 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

无锡市第五人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Wuxi Fifth People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-13 

伦理委员会联系人:

陈务兵 

Contact Name of the ethic committee:

Wubing Chen 

伦理委员会联系地址:

无锡市广瑞路1215号 

Contact Address of the ethic committee:

1215 Guangrui Road, Wuxi, Jiangsu, China 

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:

无锡市第五人民医院 

Primary sponsor:

Wuxi Fifth People's Hospital 

研究实施负责(组长)单位地址:

无锡市广瑞路1215号 

Primary sponsor's address:

1215 Guangrui Road, Wuxi, Jiangsu, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

无锡市新型冠状病毒感染应急防治科技专项目 

Source(s) of funding:

Wuxi novel coronavirus infection emergency control technology special project 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

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:

探索性研究/预试验 

Study phase:

研究目的:

利用干细胞外泌体的抑制炎症因子,和增强机体免疫力的作用,通过雾化入肺直接接触病灶的方式,促进新冠病毒肺炎患者早日康复,减少并发症。 

Objectives of Study:

Using the effect of stem cell exosomes to inhibiting inflammatory factors and enhancing the immunity of the body, and by atomizing into the lung to contact the focus directly, we can promote the early recovery of patients with new coronavirus pneumonia and reduce complications. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

符合《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》中关于湖北省以外疑似病例的诊断标准:结合下述流行病学史和临床表现综合分析:流行病学史 (1)发病前 14 天内有武汉市及周边地区,或其他有病例报告社区的旅行史或居住史; (2)发病前 14 天内与新型冠状病毒感染者(核酸检测阳性者)有接触史; (3)发病前 14 天内曾接触过来自武汉市及周边地区,或来自有病例报告社区的发热或有呼吸道症状的患者; (4)聚集性发病;临床表现: 1)发热和/或呼吸道症状; 2)具有上述肺炎影像学特征; 3)发病早期白细胞总数正常或降低,或淋巴细胞计数减少。 有流行病学史中的任何一条,且符合临床表现中任意 2 条。无明确流行病学史的,符合临床表现中的 3 条。  

Inclusion criteria

Patients meet the diagnostic criteria "Diagnosis and treatment of novel coronavirus pneumonia (trial version fifth)"for suspected cases outside Hubei Province: combined with the following epidemiological and clinical manifestations: epidemiological history 1. Patients with travel or residence history in Wuhan and surrounding areas or other communities with case reports within 14 days before the onset of the disease; 2. Patients with a novel coronavirus infection (positive for nucleic acid detection) within 14 days before onset;, 3. Patients with fever or respiratory symptoms from Wuhan and surrounding areas or from the community with case report had been contacted within 14 days before the onset of the disease; 4. Clustering disease; clinical manifestations: (1) fever and / or respiratory symptoms; (2) having the above-mentioned imaging characteristics of pneumonia; (3) normal or reduced leukocyte count or lymphocyte count in the early stage of the disease. There is any one in the epidemiological history, and it is consistent with any two in the clinical manifestations. If there is no clear epidemiological history, it is in line with 3 of the clinical manifestations. 

排除标准:

(1) 年龄<18岁或>65岁; (2)合并严重心、脑、肺、肾功能障碍、内分泌疾病和造血系统严重疾病或其他严重疾病及精神病患者; (3) 妊娠及哺乳期妇女。 

Exclusion criteria:

(1) Age < 18 or > 65; (2) Patients with severe heart, brain, lung, kidney dysfunction, endocrine disease, hematopoiesis system disease or other serious diseases and psychosis; (3) Pregnant and lactating women. 

研究实施时间:

Study execute time:

From2020-02-28To 2020-05-31 

征募观察对象时间:

Recruiting time:

From2020-03-01To 2020-04-30 

干预措施:

Interventions:

组别:

外泌体组

样本量:

13

Group:

Exocrine group

Sample size:

干预措施:

外泌体雾化吸入

干预措施代码:

Intervention:

Aerosol inhalation of exosomes

Intervention code:

组别:

对照组

样本量:

13

Group:

Control group

Sample size:

干预措施:

Blank

干预措施代码:

Intervention:

Blank

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

无锡市第五人民医院 

单位级别:

三乙医院 

Institution
hospital:

Wuxi Fifth People's Hospital  

Level of the institution:

Tertiary B Hospital 

测量指标:

Outcomes:

指标中文名:

肺部CT

指标类型:

主要指标 

Outcome:

Lung CT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咽试子核酸检测

指标类型:

次要指标 

Outcome:

Nucleic acid detection of pharyngeal test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规中白细胞和淋巴细胞

指标类型:

次要指标 

Outcome:

Leukocytes and lymphocytes in blood routine

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:

标本中文名:

口咽部分泌物

组织:

Sample Name:

Partial secretion of oropharynx

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

血液

组织:

Sample Name:

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 years
最大 Max age 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):

随机信封法

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

Random envelope method

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

中国临床试验注册中心

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

China clinical trial registry

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:

病例记录表,由研究团队成员周鹏管理

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

Case record form, managed by research team member Zhou Peng

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-26
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