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× 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× 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× 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×, 4×, 8× mL, with a minimum of 24 h between doses recorded Second cohort: Intervention of ardoxso for five days on an escalating dose 8×, 4×, 8×mL, with a minimum of 24 h between doses recorded Third cohort: Intervention of ardoxso for five days on an escalating dose 8×, 8×, 8× 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× mL exosome over five days | 1 and 2 | Not yet recruiting | 55, randomized |