About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age above 18 years.
Male or female
Subjects should have banked AdMSCs in Celltex (already passed communicable disease screen tests for HIV, syphilis, Hepatitis B and C during banking stage)
Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
Disqualifiers
Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
Unwillingness or inability to comply with study procedures
Blood test for SARS-Cov-2 antibodies IgM and IgG positive
Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
Trial design
Parallel
Treatments tested in this trial
autologous adipose-derived stem cells
Biological/VaccineCulture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
Treatment groups
Trial outcomes
Primary outcomes
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
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
COVID-19 incidence rates in both the study and control groups
efficacy
Secondary outcomes
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
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
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
Change of lymphocyte count in white blood cell counts from the baseline
efficacy
Locations
Sponsors and contacts
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