Status:
UNKNOWN
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells for the Treatment of Severe Viral Pneumonian
Lead Sponsor:
Shanghai East Hospital
Conditions:
Severe Pneumonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this clinical study is to answer the questions: 1. Is the proposed intervention safe? 2. Is the proposed intervention effective in improving the health of subjects with severe viral pn...
Detailed Description
Viral pneumonia is an acute respiratory infectious disease caused by respiratory viruses. It is mainly caused by the invasion of respiratory viruses such as influenza virus and adenovirus into the low...
Eligibility Criteria
Inclusion
- The age is 18-75 years old (inclusive), and the gender is not limited;
- According to the diagnosis standard of viral pneumonia in the influenza diagnosis and treatment plan (2019 version), patients with severe viral pneumonia were diagnosed.
- Diagnostic criteria of viral pneumonia: with clinical manifestations of influenza, with one or more of the following pathogenic test results positive: 1) influenza virus nucleic acid test positive. 2) influenza antigen was positive. 3) the culture of influenza virus was positive. 4) the level of influenza virus specific IgG antibody in the acute and recovery serum was 4 times or more higher. Diagnosis criteria of severe viral pneumonia: the confirmed patients meet any of the following criteria: 1) continuous high fever for more than 3 days, accompanied by severe cough, expectoration, blood sputum, or chest pain; 2) rapid respiratory rate, dyspnea, cyanosis of mouth and lips; 3) mental changes: slow response, drowsiness, agitation, convulsion, etc.; 4) severe vomiting, diarrhea, dehydration; 5) pneumonia; 6 ）7. Other clinical conditions requiring hospitalization
- 20kg / m2 ≤ BMI ≤ 30 kg / m2;
- Volunteer to participate in the clinical study and sign the written informed consent.
Exclusion
- Long term use of immunosuppressive drugs or organ transplantation;
- T lymphocyte abnormality (the use of allogeneic may be considered, according to the clinical opinion), HIV positive;
- High allergic constitution or severe allergic history, especially IL-2 allergic history;
- Pregnant and lactating women;
- Patients with a history of serious autoimmune diseases; those who are allergic to all biological agents in the treatment, such as IL-2;
- Patients with serious complications: Patients with chronic cardiac insufficiency (NYHA cardiac function grade IV), chronic renal insufficiency (CKD stage 4 or above), chronic liver insufficiency (child Pugh score \> 12), and patients with malignant tumors.
- There are other situations that the researcher thinks are not suitable for participating in this clinical study.
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04282928
Start Date
February 1 2020
End Date
March 1 2021
Last Update
February 25 2020
Active Locations (1)
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1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120