COVID-19 Clinical Trial
Official title:
Human Umbilical Cord Mesenchymal Stem Cells Treatment for Pneumonia Patients Infected by 2019 Novel Coronavirus
Verified date | March 2020 |
Source | Puren Hospital Affiliated to Wuhan University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The 2019 novel coronavirus pneumonia outbroken in Wuhan, China, which spread quickly to 26 countries worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, there is no effective treatment in clinical practice. The present clinical trial is to explore the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for novel coronavirus pneumonia patients.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 25, 2020 |
Est. primary completion date | February 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Male or female, 18 years old = age = 75years old; 2. CT image is characteristic of 2019 novel coronavirus pneumonia; 3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR); 4. In compliance with the 2019-nCoV pneumonia diagnosis standard (according to the novel coronavirus infection pneumonia diagnosis and treatment program (Trial Implementation Version 6) issued by the National Health and Medical Commission, and WHO 2019 new coronavirus guidelines standards): (A) increased breathing rate (=30 beats / min), difficulty breathing, cyanosis of the lips; (B) in resting state, means oxygen saturation =93%; (C) partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) =300 mmHg (1mmHg = 0.133kPa); Exclusion Criteria: 1. Patients with severe allergies or allergies to stem cells; 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 |
Country | Name | City | State |
---|---|---|---|
China | Puren Hospital Affiliated to Wuhan University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Puren Hospital Affiliated to Wuhan University of Science and Technology | Wuhan Hamilton Bio-technology Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Size of lesion area by chest imaging | Evaluation of Pneumonia change | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | |
Primary | Blood oxygen saturation | Evaluation of Pneumonia change | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | |
Secondary | Rate of mortality within 28-days | Marker for efficacy of treatment | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | |
Secondary | Sequential organ failure assessment | 0-4 score, the higher the score is, the poor of the prognosis will be. | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | |
Secondary | Side effects in the UC-MSCs treatment group | Number of participants with treatment-related adverse events | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | |
Secondary | Electrocardiogram, the changes of ST-T interval mostly | Markers of the heart function | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | |
Secondary | Concentration of C-reactive protein C-reactive protein, immunoglobulin | Markers of infection | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | |
Secondary | CD4+ and CD8+ T cells count | Marker of Immunology and inflammation | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | |
Secondary | Concentration of the blood cytokine (IL-1ß, IL-6, IL-8,IL-10,TNF-a) | Marker of Immunology and inflammation | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 | |
Secondary | Concentration of the myocardial enzymes | Markers of the heart function | At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 |
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