Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-02-15
• Target enrollment: 0
• Participant gender: All

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 coronavirus (2019-nCoV). In severe cases, there will be rapid respiratory system failure. The novel coronavirus pneumonia is extremely contagious and the disease progresses rapidly. It has become a urgent and serious public health event that threatens human life and health globally. Among them, severe pneumonia caused by novel coronavirus is characterized by extensive acute inflammation of the lungs and the patient is critically ill. At present, there is no effective treatment in clinical practice.Most of them should receive supportive care to help relieve symptoms. For severe cases, treatment should include care to support vital organ functions. This clinical trial is to inspect the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for severe pneumonia patients infected with 2019-nCoV.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Collaborator: Wuhan Hamilton Bio-technology Co., Ltd, China.

Criteria

Inclusion Criteria:

1. CT image is characteristic of viral pneumonia;

2. 2019-ncov infection (positive nucleic acid test) is confirmed by pathogenic test;

3. 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);

4. 18 years old ≤ age ≤ 65 years old, regardless of gender;

5. The patient or legal donor agrees to participate in the study and signs the informed consent.

Exclusion Criteria:

1. Patients with severe allergies or allergies to stem cell preparations and their components;

2. Patients with serious basic diseases that affect survival, including: blood diseases, cachexia, active bleeding, severe malnutrition, etc .;

3. Patients with pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia;

4. Continuous use of immunosuppressive agents or organ transplants in the past 6 months;

5. In vitro life support (ECMO, ECCO2R, RRT);

6. Expected deaths within 48 hours, uncontrolled infections;

7. Patients with malignant blood-borne diseases such as HIV or syphilis;

8. Patient with pregnancy, are planning to become pregnant or breastfeeding;

9. Patients with poor compliance and unable to complete the full study;

10. 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.);

11. There are other situations that the researchers think are not suitable to participate in this clinical study.