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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: |
ChiCTR2000030020 |
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Date of registration:
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2020-02-20 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The clinical application and basic research related to mesenchymal stem cells to treat novel coronavirus pneumonia (COVID-19)
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Scientific title:
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The clinical application and basic research related to mesenchymal stem cells to treat novel coronavirus pneumonia (COVID-19) |
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Date of first enrolment:
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2020-02-06 |
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Target sample size:
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Case series:20; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=49812 |
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Study type:
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Interventional study |
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Study design:
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Sequential
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Phase:
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N/A
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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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Liu Sha
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Address:
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35 Jiefang Avenue, Zhengxiang District, Hengyang, Hu'nan, China
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Telephone:
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+86 13544425400 |
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Email:
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liushadf@163.com |
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Affiliation:
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Second Hospital of University of South China, Hengyang |
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Name:
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Luo Zhigang
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Address:
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35 Jiefang Avenue, Zhengxiang District, Hengyang, Hu'nan, China
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Telephone:
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+86 13907342350 |
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Email:
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706885399@qq.com |
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Affiliation:
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Second Hospital of University of South China, Hengyang |
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Key inclusion & exclusion criteria
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Inclusion criteria: (1) Age 18-70 years
(2) Clinical symptoms, signs, and lung CT suggest changes in lung inflammation. Patients diagnosed with new type of coronavirus pneumonia combined with more than one nucleic acid test
(3) Clinical symptoms, signs, and lung CT suggest lung inflammation changes. Combined with more than one respiratory or blood specimen virus gene sequencing, it is highly homologous to known new coronaviruses.
(4) Negative nucleic acid or viral gene test, but New Crown Pneumonia expert group discusses cases with high suspicion of New Crown Pneumonia
(5) Voluntarily sign the informed consent and agree to comply with the requirements of the test protocol
(6) Patients can communicate in words or words. Sign informed consent
(7) The patient agrees and has the ability to complete auxiliary tests related to the trial
Exclusion criteria: (1) Subject has a history of tumor
(2) Female patients of childbearing age during pregnancy, lactation or recent birth planning
(3) Highly allergic constitution or history of severe allergies
(4) Coagulation disorders such as hemophilia
(5) Those with positive serological tests such as AIDS, syphilis, etc.
(6) Patients who have participated in or are participating in other drug trials within one month
(7) Patients who the investigator refused to participate in this clinical trial
(8) There is a large area of pulmonary vascular embolism and severe pulmonary hypertension
Age minimum:
18
Age maximum:
70
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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Case series:mesenchymal stem cells therapy;
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Primary Outcome(s)
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Coronavirus nucleic acid markers negative rate;Symptoms improved after 4 treatments;Inflammation (CT of the chest);
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Secondary Outcome(s)
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Trough and peak of pulmonary function FEV1;Lymphocyte subpopulation changes;
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Source(s) of Monetary Support
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The clinical research project Stem cell preparation costs by Hunan source product support cell biotechnology Ltd., the clinical part of the cost comes from the special research funds.
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Ethics review
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Status: Approved
Approval date: 03/02/2020
Contact:
Xiao Junhui
+86 0734 8899354
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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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