This study is an open-label, single-arm study to evaluate the safety and efficacy of Astrostem-V, allogenic adipose tissue derived mesenchymal stem cells (AdMSC), in patients with COVID-19 pneumonia. After each subject completes 12-Weeks visit (Visit 12) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs)
Medical Advancement Center of Arizona
Phoenix, Arizona, United States
RECRUITINGEpic Medical Research
Dallas, Texas, United States
RECRUITINGIncidence of adverse events
Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms.
Time frame: From baseline to Week 12
Abnormalities of physical examination, vital signs, and laboratory test
Number of subjects with treatment related adverse events as assessed by analysis of adverse events including abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination.
Time frame: From baseline to Week 12
SpO2
Change from baseline in SpO2 at every visit
Time frame: From baseline to Week 12
Mortality rate
Check survival status of the subject at Visit 6, 10(Week 4, 8 and Week 12 if follow-up is possible) and record the status on eCRF.
Time frame: Week 4, Week 8, and Week 12
Ventilator treatment status
Check the duration of the ventilator retention, check when the ventilator treatment has been completed after the baseline.
Time frame: From Week 1 to Week 12
Improvement of pneumonia assessed by radiologic examination(Chest X-ray or CT)
Perform chest X-ray every week (W1-W12) after screening, baseline, and W1 followed by 2-week intervals (W1, W2, W4, W6, W8, W12). In addition, CT is measured at week baseline, W4, W8 and W12.
Time frame: From baseline to Week 12
SOFA score (Sequential Organ Failure Assessment)
Check the SOFA score every week (W1-W12) after baseline, and W1 followed by 2-week intervals (W1, W2, W4, W6, W8, W12). Choose the worst of the six physiological measurements and score between 0 and 4 points each and check the total. If the measured value is more than 3 points, it is defined as organ failure.
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Time frame: From baseline to Week 12
2019 nCOV nucleic acid test
The Real-time PCR (RT-PCR) test for COVID-19 is measured at 2-week intervals (W1-W12) from Screening, Baseline to W1, W2, W4, W6, W8 and W12.
Time frame: From baseline to Week 12