This is a phase 2 multi-center, double-blind, randomized, placebo-control clinical trial with 200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen test negative, no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followed by a pilot study of 5 subjects to demonstrate the safety of proposed three-dose regimen of autologous AdMSCs infusions. The 100 study subjects who have previously banked their AdMSCs with Celltex, will receive three doses of autologous AdMSCs (approximately 200 million cells) intravenous infusion every three days. The 100 subjects in the control group who have previously banked their AdMSCs with Celltex will not receive any Celltex's AdMSC therapy but placebo treatments. All subjects are monitored for safety (adverse events/severe adverse events), COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2 IgM and IgG antibodies tests, blood cytokine and inflammatory (CRP, IL\_6, IL-10, TNFα) tests and disease severity evaluation for 6 months after the last dose of AdMSC infusion for the study group and 6 months after the enrollment for the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
Tolerability and acute safety of AdMSC infusion by assessment of the total number of AEs/SAEs related and non-related with the medication
adverse events and severe adverse events
Time frame: 6 months
The overall proportion of subjects who develop any AEs/SAEs related and non-related with the AdMSC infusions as compared to the control group
adverse events and severe adverse events
Time frame: 6 months
COVID-19 incidence rates in both the study and control groups
efficacy
Time frame: 6 months
The proportion of subjects who are infected by SARS-Cov-2 measured by PCR or other nuclear level-based SARS-Cov-2 virus testing in respiratory tract specimens (oropharyngeal samples) collected by oropharyngeal swab using the CDC standard method.
efficacy
Time frame: 6 months
The proportion of subjects who are infected by SARS-Cov-2 virus develop symptoms including mild, classic, severe and critical sever cases between study group and control group.
efficacy
Time frame: 6 months
Change of proportion of subjects who are infected by SARS-Cov-2 and develop IgM/IgG antibodies against SARS-Cov-2 between study group and control group.
efficacy
Time frame: 6 months
Change of lymphocyte count in white blood cell counts from the baseline
efficacy
Time frame: 6 months
Change of PaO2 arterial blood gases from the baseline
efficacy
Time frame: 6 months
Compare the proportion of subjects who develop severe COVID-19 pneumonia cases for both study and control groups
efficacy
Time frame: 6 months
COVID-19 mortality rates for both study and control groups
efficacy
Time frame: 6 months
Change of C-reactive protein (CRP) (mg/L) from the baseline
efficacy
Time frame: 6 months
Change of D-dimer (mg/L) from the baseline
efficacy
Time frame: 6 months
Change of Procalcitonin (ug)/L from the baseline
efficacy
Time frame: 6 months
Change of pro-type B natriuretic peptide (pro-BNP) (pg/mL) from the baseline
efficacy
Time frame: 6 months
Change of Bilirubin (mg/dL) from the baseline
efficacy
Time frame: 6 months
Change of Creatinine (mg/dL) from the baseline
efficacy
Time frame: 6 months
Change in blood test values for cytokine panels (IL-1β, IL-6, IL-8, IL-10, TNFα) from the baseline
efficacy
Time frame: 6 months
The proportion of subjects from SARS-CoV-2 RT-PCR positive to negativity in respiratory tract specimens (oropharyngeal samples) collected by oropharyngeal swab using the CDC standard method. as compared to control group
efficacy
Time frame: 6 months
Quantifying viral RNA in stool for baseline and final follow-up.
efficacy
Time frame: 6 months
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