Status:
UNKNOWN
Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Wuhan Hamilton Bio-technology Co., Ltd, China.
Conditions:
2019 Novel Coronavirus Pneumonia
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The novel coronavirus pneumonia is a kind of new emerging respiratory infectious disease, characterized by fever, dry cough, and chest tightness, and caused by the infection of the 2019 novel coronavi...
Detailed Description
Since December 2019, Wuhan has successively found multiple cases of patients with pneumonia infected by a novel coronavirus. With the spread of the epidemic, other cases in China and abroad have also ...
Eligibility Criteria
Inclusion
- CT image is characteristic of viral pneumonia;
- 2019-ncov infection (positive nucleic acid test) is confirmed by pathogenic test;
- In compliance with the 2019-nCoV infection severe pneumonia diagnosis standard (according to the novel coronavirus infection pneumonia diagnosis and treatment program (Trial Implementation Version 5) issued by the National Health and Medical Commission, and WHO 2019 new coronavirus guidelines standards). It is severe if it meets any of the following: (A) Increased breathing rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; (B) When inhaling, means oxygen saturation ≤93%; (C) Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa);
- 18 years old ≤ age ≤ 65 years old, regardless of gender;
- The patient or legal donor agrees to participate in the study and signs the informed consent.
Exclusion
- Patients with severe allergies or allergies to stem cell preparations and their components;
- Patients with serious basic diseases that affect survival, including: blood diseases, cachexia, active bleeding, severe malnutrition, etc .;
- Patients with pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia;
- Continuous use of immunosuppressive agents or organ transplants in the past 6 months;
- In vitro life support (ECMO, ECCO2R, RRT);
- Expected deaths within 48 hours, uncontrolled infections;
- Patients with malignant blood-borne diseases such as HIV or syphilis;
- Patient with pregnancy, are planning to become pregnant or breastfeeding;
- Patients with poor compliance and unable to complete the full study;
- The investigator determines that there may be increased risk of the subject or other conditions that interfere with the clinical trial and the judgment of the results (such as excessive stress, sensitivity or cognitive impairment, etc.);
- There are other situations that the researchers think are not suitable to participate in this clinical study.
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04273646
Start Date
April 20 2020
End Date
February 15 2022
Last Update
April 14 2020
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000