The purpose of this study is to demonstrate the safety of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UCMSCs) administered intravenously in patients with acute pulmonary inflammation due to COVID-19 with moderately severe symptoms
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Percent of participants with treatment related Serious Adverse Events (SAE)
Safety of UCMSCs will be reported as the percentage of participants in each treatment group that experienced a treatment related SAEs.
Time frame: 12 months
Change in inflammatory marker levels
Change in serum inflammatory marker levels including Interleukin (IL) IL-6, IL-2, Tumor Necrosis Factor Alpha (TNF-a) and procalcitonin will be evaluated in ng/L.
Time frame: Baseline, Day 30
Change in systemic inflammatory marker levels
Change in serum systemic inflammatory marker levels including D-dimer, high sensitivity C-reactive protein (hsCRP) and ferritin will be evaluated in mg/L.
Time frame: Baseline, Day 30
COVID-19 Viral Load
Assessed using blood samples or nose/throat swabs.
Time frame: Up to 30 Days
Change in SOFA score
Sequential Organ Failure Assessment (SOFA) will be used to assess organ failure including the cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs. SOFA score ranges from 0-24 with the higher score indicating worse outcomes.
Time frame: Baseline, Up to 30 Days
Change in electrolytes levels
Sodium, Potassium, Chloride and Carbon Dioxide (CO2) will be evaluated in mmol/L. Changes from baseline to Day 30 will be compared between groups.
Time frame: Baseline, Up to 30 Days
Change in LDH levels
Serum Lactate Dehydrogenase (LDH) levels assessed in U/L. Changes in LDH from baseline to Day 30 will be compared between groups.
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Time frame: Baseline, Up to 30 Days
Number of subjects discharged from the ICU
ICU monitoring status will be reported as the number of subjects discharged from the ICU within 7 days.
Time frame: Up to 7 Days
Percentage of participants with less requirement for vasoactive agents
Percentage of participants requiring less use of vasoactive agents will be reported.
Time frame: Up to 30 Days
Rate of Mortality
Percentage of participant deaths throughout the study period.
Time frame: Up to 30 Days
Percentage of participants with changes in immune marker expression
The percentage of participants with changes in serum immune marker levels including Cluster of Differentiation (CD) CD 4+ and CD 8+, as evaluated by treating physician will be reported.
Time frame: Up to 30 Days
Percentage of participants with changes in radiologic findings
Percentage of participants with changes in their chest imaging such as ground-glass opacity, local patch shadowing, bilateral patch shadowing and interstitial abnormalities will be reported. Imaging will be assessed by treating physician using chest radiography or chest Computed Tomography (CT).
Time frame: Up to 30 Days
Percentage of participants with less pneumonia symptoms
Percentage of participants showing less pneumonia symptoms will be reported as evaluated by treating physician using chest radiography or chest CT.
Time frame: Up to 30 Days