This is an interventional new drug clinical trial for a Phase 2 randomized, double-blind, and placebo control study using intravenous injection of allogeneic adipose stem cells (Celltex AdMSCs) for subjects with severe COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
Safety of AdMSC injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study based on the rate of all AdMSC-associated adverse events (AEs) in all subjects.
Incidence of treatment-related adverse events and severe adverse events during the study period
Time frame: 6 months
Safety for AdMSCs based upon incidence of all AEs
Grouped by Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: 6 months
Compare the mortality rate
AdMSC treating group vs. control group
Time frame: 6 months
Recognized immune measurements evaluating patients' symptom changes and overall function
To evaluate change of sequential organ failure assessment (SOFA) score as compare to the baseline
Time frame: 6 months
Organ functional tests including blood specific enzymes and proteins
To evaluate the efficacy of allogeneic AdMSCs for COVID-19
Time frame: 6 months
Duration (days) of weaning from mechanical ventilation
Compared to control group
Time frame: 6 months
Duration (days) of ICU monitoring
Compared to control group
Time frame: 6 months
Duration (days) of vasoactive agent's usage
Compared to control group
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Time frame: 6 months
Duration of hospitalization (days)
Compared to control group
Time frame: 6 months
Proportions of SARS-CoV-2 RT-PCR change to negative from respiratory tract specimens (oropharyngeal swabs) using CDC standard method
Compared to control group
Time frame: 6 months
Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method
Compared to control group
Time frame: 6 months
Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive
Compared to control group
Time frame: 6 months