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Table 4 List of recorded MSCs-Exos-based clinical studies for inhibiting COVID-19

From: Spotlight on therapeutic efficiency of mesenchymal stem cells in viral infections with a focus on COVID-19

Study Description Study design Primary Outcome Measures Recruitment Status Study identifier
This pilot clinical study will discover the harmlessness and performance of aerosol nasal route administration of the exosomes isolated from allogenic AD-MSCs (MSCs-exosome) in acute COVID-19 patient Clinical Trial. N/A, 30 participants
5 times aerosol nasal route administration of MSCs-Exos (2.0 × 108 nanovesicles/3 ml from 1–5 day)
18–75 Years
Phase I
1. Safety assessment within 28 days next to the primary therapy, containing the frequency of adverse effects and acute negative reaction
2. Performance assessment in 28 days, containing the time to clinical recovery
Completed NCT04276987
Therapy of SARS-CoV-2 Patient, who are at primary phases of pulmonary infection by SARS-CoV-2-particular T cell-isolated Exos (CSTC-Exos) to control infection development Clinical study. N/A, 60 patients. Nasal route administration of CSTC-Exo therapy will be used five times each day (2.0 × 108 nanovesicle / 3 mL; on day 1 to day 5)
18–75 Years
Phase I
1. Harmlessness evaluation: Adverse effect and acute adverse reactions in 28 days
2. Effectiveness evaluation 28 Days
3. The amount of improvement Ventilator-free, in 28 days
Active, not recruiting NCT04389385
To assess the harmlessness and effectiveness of intravenous injection of BM-ExoFlo, against placebo as therapy for regulating ARDS in severe SARS-CoV-2 infected persons A multicenter, placebo-controlled, randomized clinical study. 120 members
Experimental Dosage 1: Normal saline solution 90 mL and ExoFlo 10 mL, 800 × 109 nanovesicle
Practical dosage 2: normal saline solution 85 mL and ExoFlo 15 mL, 1.2 × 1012 Vesicles
18 Years to 85 Years
Phase II
1. All-cause death
2. Median days to improvement
Completed NCT04493242
This trial has been created based on the literature, data about the ongoing tests NCT04276987 (A Pilot Clinical trial on Inhalation of MSC-Exos improving acute SARS-CoV-2 infection), and NCT04384445 (Organicell flow for infected persons by SARS-CoV-2), Patent No 271036826 of 2019. A technique for obtaining miRNA-containing exosomal multipotent MSCs for application in cosmetic and pharmaceutical productions Interventional (Clinical Trial), 30 members, Randomized, 3 groups. All qualified trial members are randomized, double-blinded, to either the 2 therapy or placebo group
Inject twice a day for up to 10 days, aspiration of 3 ml specific solution included 0.5–2 × 1010 nanoparticles (Exos)
18 Years to 65 Years
Phase I
Phase II
1. Safety evaluation, including side effects, will be recorded. Side effects will be checked during all trials
2. Safety evaluations, including side effects during the inhalation routs, will be recorded
Completed NCT04491240