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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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25 February 2020 |
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Main ID: |
ChiCTR2000030138 |
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Date of registration:
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2020-02-24 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Trial for Human Mesenchymal Stem Cells in the Treatment of Severe Novel Coronavirus Pneumonia (COVID-19)
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Scientific title:
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Clinical Trial for Human Mesenchymal Stem Cells in the Treatment of Severe Novel Coronavirus Pneumonia (COVID-19) |
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Date of first enrolment:
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2020-02-24 |
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Target sample size:
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Experimental group:30;Control group:30; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=50004 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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2
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Countries of recruitment
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China
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Contacts
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Name:
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Jian Bo and Chuanzhu Li
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Address:
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28 Fuxing Road, Haidian Distract, Beijing, China
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Telephone:
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+86 13801257802 |
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Email:
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boj301@sina.com |
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Affiliation:
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Chinese PLA General Hospital |
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Name:
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Jian Bo
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Address:
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28 Fuxing Road, Haidian Distract, Beijing, China
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Telephone:
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+86 13801257802 |
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Email:
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boj301@sina.com |
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Affiliation:
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Chinese PLA General Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Subjects who met all of the following conditions entered the trial:
1. Male or female patients aged 16 to 75 years;
2. willing to sign informed consent;
3. Based on the criteria for suspected cases of COVID-19 infection, sputum, throat swabs, lower respiratory tract secretions and other specimens were tested for positive COVID-19 nucleic acid by real-time fluorescent RT-PCR; or viral gene sequencing was performed with known COVID- 19 highly homologous;
4. The imaging findings are consistent with pneumonia.
Exclusion criteria: Subjects who meet one of the following conditions will not be eligible for the trial:
1. pregnant or lactating women;
2. Malignant tumors, patients with other severe systemic diseases and mental illness;
3. Those who have recently participated in other clinical trials;
4. There is evidence of drug addiction within one year before joining the trial;
5. Unable or unwilling to provide informed consent or comply with test requirements;
6. Combined with HIV, tuberculosis, influenza virus, adenovirus and other respiratory infections.
Age minimum:
16
Age maximum:
75
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Novel Coronavirus Pneumonia (COVID-19)
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Intervention(s)
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Experimental group:Intravenous injection of human umbilical cord mesenchymal stem cells (UC-MSC);Control group:Routine treatment + placebo;
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Primary Outcome(s)
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Clinical index;
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Source(s) of Monetary Support
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Chinese PLA General Hospital
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Ethics review
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Status: Not approved
Approval date: 26/08/2013
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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