Cancelled by the investigator Umbilical cord mesenchymal stem cells (hucMSCs) in the treatment of high risk novel coronavirus pneumonia (COVID-19) patients

• Register: ChiCTR
• Last refreshed on: 20 April 2020
• Main ID: ChiCTR2000030300
• Date of registration: 2020-02-28
• Prospective Registration: No
• Primary sponsor: Nanjing Second Hospital
• Public title: Cancelled by the investigator Umbilical cord mesenchymal stem cells (hucMSCs) in the treatment of high risk novel coronavirus pneumonia (COVID-19) patients
• Scientific title: Umbilical cord mesenchymal stem cells for the treatment of patients at high risk of novel coronavirus pneumonia (COVID-19): a single-center, prospective, open clinical study
• Date of first enrolment: 2020-02-20
• Target sample size: Case series:9;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=50022
• Study type: Interventional study
• Study design: Non randomized control
• Phase: 1

Countries of recruitment

China

Contacts

• Name: Yongxiang Yi
• Affiliation: Nanjing Second Hospital

• Name: Yongxiang Yi
• Affiliation: Nanjing Second Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. Upon the judgment of the researcher, the subject or his legal representative can understand and comply with the requirements of the program, and voluntarily sign the informed consent;
2. According to the new type of coronavirus pneumonia diagnosis and treatment scheme (trial version 5) diagnostic criteria, accord with standard of new coronavirus pneumonia confirmed cases, clinical diagnostic criteria for classification to heavy (pneumonia severity index (PSI) III - V level, or arterial blood oxygen partial pressure (PaO2 / oxygen concentration (FiO2) (P/F) 300 mmHg) or less;
3. Aged 18 to 75 years male or female.
Exclusion criteria: 1. The subject has a history of substance abuse (defined as the use of any illicit drug) or alcohol abuse within the first year of screening;
2. The subject suffers from active psychosis, which the researcher believes may interfere with their compliance with the study process;
3. Subjects are unable to participate in all study visits or follow study procedures;
4. The subject is a staff member of the research center or a member of his or her immediate family or relatives (such as spouse, parents, children, siblings) performing the study or the subject is compelled to agree to participate in the study;
5. Female subjects during lactation, or female subjects with positive results of serum pregnancy test during screening, or female subjects with positive results of urine pregnancy test before drug administration;
6. Have participated in other clinical research projects;
7. Subjects have hypersensitivity reactions or allergic reactions to the stem cell preparation or its components;
8. The subject suffers from any unstable or uncontrolled cardiovascular, lung, liver, kidney, gastrointestinal, urogenital, hematology, coagulation, immunology, endocrine/metabolic or other medical conditions that the investigator considers to interfere with the outcome of the study or endanger the subject's safety;
9. The subject has a history of malignant tumor;
10. Subjects have a history of severe neurological disorders, including stroke, multiple sclerosis, brain tumors, or neurodegenerative diseases.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

Novel Coronavirus Pneumonia (COVID-19)

Intervention(s)

Case series:mesenchymal stem cells therapy;

Primary Outcome(s)

Time to disease recovery;Exacerbation (transfer to RICU) time;

Source(s) of Monetary Support

At his own expense

Ethics review

Status: Approved
Approval date: 19/02/2020
Contact:

Zheng qin, Chen yuling, shao yan, liu lei, zhao hong, han guorong, tao Chen, wang jian, wei qiang, zhang shaofeng, hu liang