今天是:2020-05-29 星期五

宫血干细胞治疗新型冠状病毒肺炎(COVID-19)急性肺损伤(肺炎)的临床研究
下载XML文档

注册号:

Registration number:

ChiCTR2000029606 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

宫血干细胞治疗新型冠状病毒肺炎(COVID-19)急性肺损伤(肺炎)的临床研究 

Public title:

Clinical Study for Human Menstrual Blood-Derived Stem Cells in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

宫血干细胞治疗新型冠状病毒肺炎(COVID-19)急性肺损伤(肺炎)的临床研究 

Scientific title:

Clinical Study for Human Menstrual Blood-derived Stem Cells in the Treatment of Acute 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:

项春生 

研究负责人:

李兰娟 /徐小微/项春生 

Applicant:

Charlie Xiang 

Study leader:

Lanjuan Li /Xiaowei Xu/Charile Xiang 

申请注册联系人电话:

Applicant telephone:

+86 13906507155 

研究负责人电话:

Study leader's telephone:

+86 0571-87236426 

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:

cxiang@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

ljli@zju.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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

310003 

申请人所在单位:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital, College of Medicine, Zhejiang University 

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]GXB伦审001号 

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:

浙江大学医学院附属第一医院干细胞伦理委员会 

Name of the ethic committee:

Ethics Committee on Stem Cell of the First Affiliated Hospital of Zhejiang University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-24 

伦理委员会联系人:

陈作兵 

Contact Name of the ethic committee:

Zuobing Chen 

伦理委员会联系地址:

浙江省杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0571-87236560 

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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital, College of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

庆春路79号

Institution
hospital:

The First Affiliated Hospital, College of Medicine, Zhejiang University

Address:

79 Qingchun Road

经费或物资来源:

浙江省科技厅应急项目“新型冠状病毒感染的肺炎防治技术研究” 

Source(s) of funding:

Emergency Project of Science Technology Department of Zhejiang Province “Research on Pneumonia Prevention and Treatment Technology of 2019-nCoV Infection 

研究疾病:

新型冠状病毒(COVID-19)导致急性肺损伤后的肺炎 

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:

评估宫血干细胞和人工肝治疗2019-nCoV肺炎的有效性,宫血干细胞治疗2019-nCoV肺炎的安全性,探索治疗2019-nCoV肺炎的标准治疗方案,建立有效性和安全性评估体系,为2019-nCoV肺炎防治开创新的有效方法,提高治疗有效率和病人生存率,降低病死率。 

Objectives of Study:

Evaluate the efficacy and safety of Human Menstrual Blood-derived Stem Cells(Mensc) and artificial liver in the treatment of Acute lung Injury (Pneumonia) caused by novel coronavirus pneumonia (NCP), and explore the standard treatment in the treatment of novel coronavirus pneumonia (NCP), establish the effectiveness and safety evaluation system, and create new and effective methods for the novel coronavirus pneumonia (NCP) prevention and treatment, improve the treatment efficiency and patient survival rate, reduce mortality. 

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:

1. 确诊为2019-nCoV肺炎患者: 1)诊断标准依据:《关于印发新型冠状病毒感染的肺炎诊疗方案(试行第四版)的通知》(国卫办医函C2020377号); 2019-nCoV肺炎诊断: (1)流行病学史:A.发病前14天内有武汉地区或其他有本地病例持续传播地区的旅行史或居住史;B.发病前14天内曾接触过来自武汉市或其他有本地病例持续传播地区的发热或有呼吸道症状的患者;C.有聚集性发病或与新型冠状病毒感染者有流行病学关联。 (2)临床表现:A.发热;B.具有肺炎影像学特征:早期呈现多发小斑片影及间质改变,以肺外带明显,进而发展为双肺多发磨玻璃影、浸润影,严重者可出现肺实变,胸腔积液少见;C.发病早期白细胞总数正常或降低,或淋巴细胞计数减少。 (3)有流行病学史中的任何一条,符合临床表现中任意2条为疑似病例,具备以下病原学证据之一者为确诊病例:A.呼吸道标本或血液标本实时荧光RT-PCR检测新型冠状病毒核酸阳性;B.呼吸道标本或血液标本病毒基因测序,与已知的新型冠状病毒高度同源。 (4)符合下列任何一条为重型:A.呼吸窘迫,RR>30次/分;B.静息状态下,指氧饱和度<93%;C.动脉血氧分压(PaO2)/吸氧浓度(FiO2)≦300mmHg(lmmHg=0.133kPa; (5) 符合下列任何一条为危重型: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. 患者或法定授权人同意参加本研究并签署知情同意书。 

Inclusion criteria

1. Diagnosed as novel coronavirus pneumonia (NCP) Patient: 1) Basis of diagnostic criteria: "Notice on Printing and Distributing Pneumonia Diagnosis and Treatment Plan for New Coronavirus Infection (Trial Implementation Fourth Edition)" (National Health Office Medical Letter C2020377) 2019-nCoV diagnosis of pneumonia: (1) Epidemiological history: A. Travel history or residence history in Wuhan area or other areas with continuous local case transmission within 14 days before onset; B. Contact history within 14 days before onset Patients with fever or respiratory symptoms from Wuhan City or other areas where local case transmission is ongoing; C. Aggregative onset or epidemiological association with new coronavirus infection. (2) Clinical manifestations: A. fever; B. imaging characteristics of pneumonia: multiple small patchy shadows and interstitial changes in the early stage, which are obvious in the extrapulmonary zone, and then develop into multiple ground glass infiltrates and infiltrates, which are severe Patients may have pulmonary consolidation, and pleural effusion is rare; C. The total number of white blood cells is normal or reduced in the early stage of onset, or the lymphocyte count is reduced. (3) Any one of the epidemiological history meets any two of the clinical manifestations as suspected cases, and those who have one of the following pathogenic evidence are confirmed cases: A. A new type of real-time fluorescence RT-PCR test for respiratory specimens or blood specimen Coronavirus-positive nucleic acid; B. Sequencing of viral genes in respiratory specimens or blood specimens, highly homologous to known new coronaviruses. (4) It is severe if it meets any of the following: A. Respiratory distress, RR > 30 beats / min; B. In resting state, means oxygen saturation < 93%; C. Arterial partial pressure of oxygen (PaO2) / oxygen Concentration (FiO2) <= 300mmHg (lmmHg = 0.133kPa). (5) It is critical if it meets 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. The patient or legal donor agrees to participate in the study and signs an informed consent form. 

排除标准:

1. 妊娠期和哺乳期妇女; 2. 存在影响本疗效判断的合并症,如恶性肿瘤或长期免疫抑制剂者; 3. 研究者认为患者存在不适合入组的其他情况; 4. 二甲基亚砜(DMSO)、右旋糖酐40或人血白蛋白过敏者; 5. 人工肝治疗禁忌征。 

Exclusion criteria:

1. Pregnant or lactating women; 2. There are comorbidities that affect the judgment of the efficacy, such as those with malignant tumors or long-term immunosuppressants; 3. The investigator believes that the patient has other conditions that are not suitable for enrollment; 4. Allergic to dimethyl sulfoxide (DMSO), dextran 40 or human albumin; 5. Contraindicated signs of artificial liver therapy 

研究实施时间:

Study execute time:

From2020-01-15To 2022-12-31 

干预措施:

Interventions:

组别:

试验组A

样本量:

18

Group:

experimental group A

Sample size:

干预措施:

常规治疗+静脉输注宫血干细胞制剂

干预措施代码:

Intervention:

Conventional treatment followed by Intravenous infusion of Human Menstrual Blood-derived Stem Cells preparations

Intervention code:

组别:

对照组A

样本量:

15

Group:

control gorup A

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

组别:

试验组B1

样本量:

10

Group:

Experimental Group B1

Sample size:

干预措施:

人工肝治疗+常规治疗

干预措施代码:

Intervention:

Artificial liver therapy+conventional treatment

Intervention code:

组别:

试验组B2

样本量:

10

Group:

Experimental Group B2

Sample size:

干预措施:

人工肝治疗+静脉输注宫血干细胞制剂+常规治疗

干预措施代码:

Intervention:

Artificial liver therapy followed by Intravenous infusion of Human Menstrual Blood-derived Stem Cells preparations+conventional treatment

Intervention code:

组别:

对照组B

样本量:

10

Group:

Control Gorup A

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

杭州市 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital, College of Medicine, Zhejiang University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

患者的病死率

指标类型:

主要指标 

Outcome:

Mortality in patients

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者的好转率

指标类型:

次要指标 

Outcome:

Improvement rate in patients

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

休克的发生率

指标类型:

次要指标 

Outcome:

Incidence of shock

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

多脏器功能衰竭的发生率

指标类型:

次要指标 

Outcome:

Incidence of multiple organ failure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院天数,住ICU天数

指标类型:

次要指标 

Outcome:

Days in hospital, days in ICU

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无创通气模式和参数

指标类型:

次要指标 

Outcome:

Non-invasive ventilation modes and parameters

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

气管插管辅助通气模式和参数

指标类型:

次要指标 

Outcome:

Intubation-assisted ventilation modes and parameters

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体外膜肺氧合模式和参数

指标类型:

次要指标 

Outcome:

Extracorporeal membrane oxygenation patterns and parameters

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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 1 years
最大 Max age 99 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):

本次试验采用中央随机方式为受试者分派随机号和配发相应研究药物。

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

In this trial, subjects were assigned a random number and a corresponding study drug using a central random method.

盲法:

开放

Blinding:

open label

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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 staff trained. The data is then filled in a designed 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.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-07
返回列表