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脐带间充质干细胞治疗重型和危重型新型冠状病毒肺炎(COVID-19)的开放性临床观察研究
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注册号:

Registration number:

ChiCTR2000030866 

最近更新日期:

Date of Last Refreshed on:

2020-03-18 

注册时间:

Date of Registration:

2020-03-16 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

脐带间充质干细胞治疗重型和危重型新型冠状病毒肺炎(COVID-19)的开放性临床观察研究 

Public title:

Open-label, observational study of human umbilical cord derived mesenchymal stem cells in the treatment of severe and critical patients with novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脐带间充质干细胞治疗重型和危重型新型冠状病毒肺炎的开放性临床观察研究 

Scientific title:

Open-label, observational study of human umbilical cord derived mesenchymal stem cells in the treatment of severe and critical COVID-1 

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:

欧阳琦 

研究负责人:

谢元林 

Applicant:

Ouyang Qi 

Study leader:

Xie yuanlin 

申请注册联系人电话:

Applicant telephone:

+86 18508405717 

研究负责人电话:

Study leader's telephone:

+86 13975137399 

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:

5138096@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1286779459@qq.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:

中国湖南省长沙市岳麓区麓云路8号 

研究负责人通讯地址:

中国湖南省长沙市开福区营盘路311号 

Applicant address:

8 Luyun Road, Yuelu District, Changsha, Hu'nan, China 

Study leader's address:

311 Yingpan Road, Kaifu District, Changsha, Hu'nan, 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:

湖南光琇高新生命科技有限公司 

Applicant's institution:

Hunan GuangXiu-Gaoxin Life Science Co., Ltd. 

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:

2020022701 

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:

长沙市第一医院干细胞临床研究伦理委员会 

Name of the ethic committee:

Stem cell clinical research ethics committee of the First Hospital of Changsha 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-29 

伦理委员会联系人:

杨玲 

Contact Name of the ethic committee:

Yang Lin 

伦理委员会联系地址:

湖南省长沙市开福区营盘路311号 

Contact Address of the ethic committee:

311 Yingpan Road, Kaifu District, Changsha, Hu'nan, 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:

长沙市第一医院 

Primary sponsor:

The First Hospital of Changsha 

研究实施负责(组长)单位地址:

湖南省长沙市开福区营盘路311号 

Primary sponsor's address:

311 Yingpan Road, Kaifu District, Changsha, Hu'nan, 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):

湖南省

市(区县):

长沙

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

湖南光琇高新生命科技有限公司

具体地址:

中国湖南省长沙市岳麓区麓云路8号

Institution
hospital:

Hunan GuangXiu-Gaoxin Life Science Co., Ltd.

Address:

8 Luyun Road, Yuelu District

国家:

中国

省(直辖市):

湖南省

市(区县):

长沙市

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

长沙市第一医院

具体地址:

湖南省长沙市开福区营盘路311号

Institution
hospital:

The First Hospital of Changsha

Address:

311 Yingpan Road, Kaifu District

经费或物资来源:

湖南省科技厅抗击新冠肺炎疫情应急项目 

Source(s) of funding:

Emergency Projects for COVID-19 set up by Science and Technology Department of Hunan Province  

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:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

(1)评估脐带间充质干细胞治疗新型冠状病毒肺炎重型/危重型患者的临床安全性和有效性。 (2)降低重型患者向危重型患者的转化率,增加危重型患者向重型患者的转化率,提高治愈率 

Objectives of Study:

(1) Evaluate the clinical safety and effectiveness of umbilical cord mesenchymal stem cells in the treatment of severe and critical COVID-19 patients; (2) Reduce the conversion rate of severe patients to critical patients, increase the conversion rate of critical patients to severe patients, and improve the cure rate. 

药物成份或治疗方案详述:

第0天、3天、6天静脉输注1×10^6个间充质干细胞/kg/次,共3次 

Description for medicine or protocol of treatment in detail:

Intravenous infusion of 1×10^6 UCMSCs/kg/time on day 0, 3, 6 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1.确诊为新型冠状病毒肺炎重型/危重型患者;或病毒核酸检测转阴,但仍具有以下重型/危重型表现的患者: 根据国家卫生健康委员会颁布的《新型冠状病毒肺炎诊疗方案(试行第六版)》,符合下列任何一条确诊为重型肺炎: 1)出现气促,RR≥30次/分; 2)静息状态下,指氧饱和度≤93%;3)动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg(1mmHg=0.133kPa)。 符合下列任何一条确诊为危重型肺炎: 1)出现呼吸衰竭,且需要机械通气; 2)出现休克; 3)合并其他器官功能衰竭需ICU监护治疗; 2.患者(或委托代理人)知情同意、自愿参加并签署知情同意书。 

Inclusion criteria

1. Patients diagnosed as severe or critical COVID-19; or patients who have turned negative for viral nucleic acid detection but still have the following severe or critical manifestations: According to the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Version 6)" promulgated by the National Health Commission, any of the following is confirmed to be diagnosed as severe COVID-19: 1) shortness of breath, RR >=30 times / minute; 2) in a resting state , Oxygen saturation<=93%; 3) arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <=300mmHg (1mmHg = 0.133kPa). The diagnosis of critical COVID-19 is consistent with any of the following: 1) respiratory failure occurs and requires mechanical ventilation; 2) shock occurs; 3) combined organ failure requires ICU monitoring and treatment; 2. Informed consent, voluntary participation and signing of informed consent by patients (or entrusted agents). 

排除标准:

(1)既往有肺栓塞病史; (2)人类免疫缺陷病毒(HIV)感染患者; (3)恶性肿瘤患者:经过完全治疗的子宫颈原位癌、皮肤非转移性鳞状或基底细胞癌患者除外; (4)妊娠期和哺乳期妇女; (5)临床医师认为其他不适宜应用的情形。 

Exclusion criteria:

(1) Past medical history of pulmonary embolism; (2) Patients infected with human immunodeficiency virus (HIV); (3) Patients with malignant tumors: Patients with cervical carcinoma in situ, skin non metastatic squamous or basal cell carcinoma after complete treatment are excluded; (4) pregnant and lactating women; (5) Other situations that the clinician considers unsuitable. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2020-02-01To 2020-12-31 

干预措施:

Interventions:

组别:

MSC组

样本量:

30

Group:

MSC group

Sample size:

干预措施:

常规治疗基础上,静脉输注间充质干细胞

干预措施代码:

Intervention:

Intravenous infusion of MSC based on conventional treatments

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China 

Province:

Hu’nan 

City:

Changsha 

单位(医院):

长沙市第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Hospital of Changsha  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

氧合指数(动脉血氧分压(PaO2)/氧浓度(FiO2))

指标类型:

主要指标 

Outcome:

Oxygenation index (arterial oxygen partial pressure (PaO2) / oxygen concentration (FiO2))

Type:

Primary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天、随机/出院后14天、随机/出院后28天、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

0 hour, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days, random /14 days after discharge, random /28 days after discharge, 3 months, 6 months, 12 months

Measure method:

指标中文名:

重型向危重型患者的转化率

指标类型:

主要指标 

Outcome:

Conversion rate from serious to critical patients

Type:

Primary indicator 

测量时间点:

28天

测量方法:

Measure time point of outcome:

day 28

Measure method:

指标中文名:

危重型向重型患者的转化率及转化时间

指标类型:

主要指标 

Outcome:

Conversion rate and conversion time from critical to serious patients

Type:

Primary indicator 

测量时间点:

28天

测量方法:

Measure time point of outcome:

day 28

Measure method:

指标中文名:

重型和危重型患者的病死率

指标类型:

主要指标 

Outcome:

Mortality in serious and critical patients

Type:

Primary indicator 

测量时间点:

28天

测量方法:

Measure time point of outcome:

day 28

Measure method:

指标中文名:

肺部低剂量螺旋CT(特殊情况下由研究者根据受试者实际情况决定是否采用其他影像学检查)

指标类型:

次要指标 

Outcome:

Low-dose spiral CT of the lung (in special cases, the investigator decides whether to use other imaging tests based on the actual situation of the patient)

Type:

Secondary indicator 

测量时间点:

基线、3天、6天、10天、14天、28天随机/出院后14天、随机/出院后28天、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

baseline, 3 days, 6 days, 10 days, 14 days, 28 days, random /14 days after discharge, random /28 days after discharge, 3 months, 6 months, 12 months

Measure method:

指标中文名:

峰流速仪

指标类型:

次要指标 

Outcome:

Peak flow meter

Type:

Secondary indicator 

测量时间点:

随机/出院后14天、随机/出院后28天、3个月、6个月、12个月

测量方法:

Measure time point of outcome:

random /14 days after discharge, random /28 days after discharge, 3 months, 6 months, 12 months

Measure method:

指标中文名:

新型冠状病毒核酸检测

指标类型:

次要指标 

Outcome:

COVID-19 nucleic acid detection

Type:

Secondary indicator 

测量时间点:

基线、3、6、10、14、28天

测量方法:

Measure time point of outcome:

baseline, 3, 6, 10, 14, 28 days

Measure method:

指标中文名:

外周血淋巴细胞亚群(总T细胞、CD4+T细胞、CD8+ T细胞、B细胞、NK细胞等)

指标类型:

次要指标 

Outcome:

Peripheral blood lymphocyte subsets (total T cells, CD4 + T cells, CD8 + T cells, B cells, NK cells, etc.)

Type:

Secondary indicator 

测量时间点:

0、3、6、10、14、28天

测量方法:

Measure time point of outcome:

0, 3, 6, 10, 14, 28 days

Measure method:

指标中文名:

细胞因子检测(IL-1β,IL-2, IL-6,IL-10 和 TNFα等)

指标类型:

次要指标 

Outcome:

Cytokine detection (IL-1beta, IL-2, IL-6, IL-10, TNFalpha, etc.)

Type:

Secondary indicator 

测量时间点:

0小时、6小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 6 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

序贯性器官衰竭评估(SOFA)

指标类型:

次要指标 

Outcome:

Sequential organ failure assessment

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

APACHE II评分

指标类型:

次要指标 

Outcome:

APACHE II score

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

急性肺损伤评分

指标类型:

次要指标 

Outcome:

Acute lung injury score

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

Blood routine

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天、6个月、12个月

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days、6 months、12 months

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标 

Outcome:

C-reactive protein

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

肝肾功能

指标类型:

次要指标 

Outcome:

liver and kidney function

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

肿瘤标志物12项

指标类型:

副作用指标 

Outcome:

12 tumor markers

Type:

Adverse events 

测量时间点:

基线、6个月、12个月

测量方法:

Measure time point of outcome:

baseline, 6 months, 12 months

Measure method:

指标中文名:

电解质

指标类型:

次要指标 

Outcome:

electrolyte

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

心肌酶

指标类型:

次要指标 

Outcome:

myocardial enzymes

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

降钙素原

指标类型:

次要指标 

Outcome:

procalcitonin

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

凝血功能

指标类型:

次要指标 

Outcome:

coagulation function

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

D-二聚体

指标类型:

次要指标 

Outcome:

D-dimer

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

动脉血气分析

指标类型:

次要指标 

Outcome:

arterial blood gas analysis

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

指标中文名:

呼吸功能支持类型及参数

指标类型:

次要指标 

Outcome:

Respiratory function support types and parameters

Type:

Secondary indicator 

测量时间点:

0小时、24小时、3天、6天、10天、14天、28天

测量方法:

Measure time point of outcome:

0 hours, 24 hours, 3 days, 6 days, 10 days, 14 days, 28 days

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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:

标本中文名:

咽拭子

组织:

Sample Name:

Throat swab

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 85 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):

不适用

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

Not applicable

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):

是否共享原始数据:

IPD sharing

否No

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):

相关网站和文章

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

Related websites and articles

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:

将由接受过培训的工作人员采集所有数据。然后将数据填写在设计的病例报告表(CRF)中,定期由项目组成员录入电子数据库中。研究者负责确保录入采集数据的完整、准确与及时记录。然后由项目组对病历中的数据进行审查。按照适用的标准和数据清理程序进行临床数据管理,以确保数据的完整性。

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

All data will be collected by trained staff. The data will be filled in a case report form (CRF), which is regularly entered by the project team members into an electronic database . The investigator is responsible for ensuring that the data entered is complete, accurate, and timely. The project team then reviews the data in the medical records. Manage clinical data in accordance with applicable standards and data cleaning procedures to ensure data integrity.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-03-16
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