Cancelled by the investigator Clinical study of mesenchymal stem cells in treating severe novel coronavirus pneumonia (COVID-19)

• Register: ChiCTR
• Last refreshed on: 23 March 2020
• Main ID: ChiCTR2000030224
• Date of registration: 2020-02-26
• Prospective Registration: Yes
• Primary sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Public title: Cancelled by the investigator Clinical study of mesenchymal stem cells in treating severe novel coronavirus pneumonia (COVID-19)
• Scientific title: Clinical study of mesenchymal stem cells in treating severe novel coronavirus pneumonia (COVID-19)
• Date of first enrolment: 2020-02-26
• Target sample size: 1 the critical group :8;2 the severe group:8;3 the control group of the critical group:8;4 the control group of the severe group:8;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=49968
• Study type: Interventional study
• Study design: Parallel
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Chengyun Liu
• Affiliation: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

• Name: Chengyun Liu
• Affiliation: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Key inclusion & exclusion criteria

Inclusion criteria: 1. Female patients aged >=18 years who were of childbearing years were excluded from pregnancy and agreed to use non-drug contraceptive measures during the study period;
2. SARS-CoV-2 nucleic acid test positive;
3. Lung CT examination showed evaluable lesions;
4. Meet the diagnostic criteria for severe or critical illness in the diagnosis and treatment program for new coronavirus pneumonia (trial version 6);
5. Subjects voluntarily participate in the study and sign the informed consent.
Exclusion criteria: 1. Allergy to drugs and excipients used in this study;
2. Pregnant and lactating women and women of child-bearing years did not agree to use contraception during the experiment;
3.Have malignant tumor or hypercoagulant state;
4. Suffer from mental illness and can't cooperate well;
5. Those who have participated in or are participating in clinical trials of other drugs during the course of the disease;
6. Other conditions considered inappropriate for inclusion by the researcher.

Age minimum: 18
Age maximum: 100
Gender: Both

Health Condition(s) or Problem(s) studied

Novel Coronavirus Pneumonia (COVID-19)

Intervention(s)

1 the critical group :injecting Mesenchymal stem cells;2 the severe group:injecting Mesenchymal stem cells;3 the control group of the critical group:injecting normal saline;4 the control group of the severe group:injecting normal saline;

Primary Outcome(s)

SP02;lesions of lung CT;temperature;Blood routine;Inflammatory biomarkers;

Secondary Outcome(s)

hepatic and renal function;

Source(s) of Monetary Support

other

Ethics review

Status: Approved
Approval date: 20/02/2020
Contact:

Lei Zhong