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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: |
ChiCTR2000030088 |
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Date of registration:
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2020-02-22 |
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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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Umbilical cord Wharton's Jelly derived mesenchymal stem cells in the treatment of severe novel coronavirus pneumonia (COVID-19)
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Scientific title:
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Umbilical cord Wharton's Jelly derived 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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2020-03-01 |
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Target sample size:
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Experimental group:20;Control group:20; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=49902 |
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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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0
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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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Lianru Gao
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Address:
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6 Fucheng Road, Haidian District, Beijing, China
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Telephone:
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+86 18600310121 |
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Email:
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lianru666@163.com |
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Affiliation:
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The Sixth Medical Center of PLA General Hospital |
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Name:
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Ningkun Zhang
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Address:
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6 Fucheng Road, Haidian District, Beijing, China
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Telephone:
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+86 13011864761 |
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Email:
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zhangningkun2004@163.com |
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Affiliation:
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The Sixth Medical Center of PLA General Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) age 18-80 years old, regardless of gender: 2) the diagnosis criteria of severe nCoV pneumonia in line with the 6th edition of China's new coronavirus pneumonia diagnosis scheme: a.B. Real-time fluorescence rt-pcr of respiratory tract specimens or blood samples was used to detect positive nCoV nucleic acid;3) critical cases of nCoV pneumonia: meet one of the following criteria: a. respiratory failure and mechanical ventilation required;B. shock;C. Combined with other organ failure, intensive care unit is required;4) patients with poor treatment response: that is, the above critically ill patients have undergone active modern medicine to fight against shock, correct acidosis, improve multi-organ function rescue and ECMO assisted breathing, and have not been improved by circulation assisted treatment and hormone application;5) those who signed the informed consent and agreed to participate in the initial clinical trial were selected.
Exclusion criteria: No
Age minimum:
18
Age maximum:
80
Gender:
Both
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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:Iv injection of Wharton's Jelly mesenchymal stem cells (1×10^6/kg), cell suspension volume: 40ml;Control group:Iv 40ml saline;
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Primary Outcome(s)
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The nucleic acid of the novel coronavirus is negative;CT scan of ground glass shadow disappeared;
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Source(s) of Monetary Support
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Funding for emergency research projects
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Ethics review
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Status: Approved
Approval date: 30/08/2018
Contact:
Wei Zhang
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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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