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. 2021 Aug 7;32(2):e2281. doi: 10.1002/rmv.2281

TABLE 2.

Clinical trials performed with mesenchymal stem cell‐derived exosomes on COVID‐19 patients (www.clinicaltrials.gov)

Trial identification Official title Exosome source Administration route Dosage Phase Status Enrolment and allocation (Estimated/Actual)
NCT04276987 A pilot clinical study on aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells in the treatment of severe patients with novel coronavirus pneumonia Allogenic adipose mesenchymal stem cells Inhalation 2.0×108 of nano particle/3ml For the first five days 1 Completed 24
NCT04491240 The protocol of evaluation of safety and efficiency of method of exosome inhalation in SARS‐CoV‐2 associated two‐sided pneumonia MSC Inhalation Exo 1: Twice a day inhalation of 3ml solution containing 0.5‐2×10^10 nanoparticles of type 1 exosome for 10 days Exo 2: Twice a day inhalation of 3mL solution containing 0.5‐2×1010 nanoparticles of type 2 exosome for 10 days Placebo: Twice a day inhalation of 3mL solution free of nanoparticle 1 and 2 Completed 30, randomized
NCT04602442 Safety and efficiency of method of exosome inhalation in COVID‐19 associated pneumonia (COVID‐19EXO2) MSC Inhalation Exo 1: Twice a day inhalation of 3ml solution containing 0.5‐2×10^10 nanoparticles of type 1 exosome for 10 days Exo 2: Twice a day inhalation of 3mL solution containing 0.5‐2×1010 nanoparticles of type 2 exosome for 10 days Placebo: Twice a day inhalation of 3mL solution free of nanoparticle 2 Enrolling by invitation 90, randomized
NCT04798716 Mesenchymal stem cell exosomes for the treatment of COVID‐19 positive patients with acute respiratory distress syndrome and/or novel coronavirus pneumonia MSC Intravenous First cohort: Intervention of ardoxso for five days on an escalating dose 2×109, 4×109, 8×109 mL, with a minimum of 24 h between doses recorded Second cohort: Intervention of ardoxso for five days on an escalating dose 8×109, 4×109, 8×109mL, with a minimum of 24 h between doses recorded Third cohort: Intervention of ardoxso for five days on an escalating dose 8×109, 8×109, 8×109 mL, with a minimum of 24 h between doses recorded Fourth cohort: Randomized control ratio 1:3 25% of patients will receive 3 doses of placebo over five days75% of patients will three doses of 8×109 mL exosome over five days 1 and 2 Not yet recruiting 55, randomized