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. 2020 Nov 12;234:105009. doi: 10.1016/j.chemphyslip.2020.105009

Table 1.

List of registered exosome based clinical trials for treating COVID-19.

location Study identifier Main goal Study design Primary Outcome Measures
China, Shanghai Public Health Clinical Center NCT04276987 explore the safety and efficiency of aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exo) in treatment of severe patients with novel coronavirus pneumonia (NCP) Clinical Trial. N/A, 30 participants 5 times aerosol inhalation of MSCs-Exo (2 × 10 (Xu et al., 2020) nano vesicles/3 mL at Day 1to Day 5). 1.Safety evaluation within 28 days after the first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE)
2.Efficiency evaluation within 28 days, including the time to clinical improvement (TTIC)
Kayseri, Melikgazi, Turkey NCT04389385 Treatment of COVID-19 patients -who are at early stages of pulmonary disease- with COVID-19 Specific T Cell-derived exosomes (CSTC-Exo) to control disease progression. Clinical Trial. N/A, 60 participants. COVID-19 Specific T Cell-derived exosomes (CSTC-Exo). Inhaler CSTC-Exo treatment will be applied daily x 5 times (2.0 × 108 nano vesicle / 3 mL; on day 1 to day 5). 1. Safety Assessment: Adverse reaction (AE) and severe AE (SAE) within 28 days
2. Efficacy Assessment .28 Days
Time to Clinical Recovery (TTCR)
3. The Rate of Recovery Without Mechanical Ventilator, within 28 days
United States, Florida. Landmark Hospital NCT04384445 Investigate safety and potential efficacy of human amniotic fluid (HAF) derived acellular product in subjects suffering from COVID-19 infection with the severe acute respiratory syndrome (SARS). Phase I/II Randomized, 20 participants, Parallel Assignment, two groups of treatment and placebo, each with 10 subjects (n = 20). Randomized and double-blinded. Organicell Flow will be administered intravenously with 1 mL, containing 2−5 × 10^11 particles/mL in addition to the Standard Care 1. Safety will be defined by the incidence of infusion associated with adverse events as assessed by treating physician within 60 Days.
2. Safety will be defined by the incidence of severe adverse events as assessed by treating physician within 60 Days.
China ChiCTR2000030261 Investigate the effect of stem cell exosomes to inhibiting inflammatory factors and enhancing the immunity of the body, and by atomizing into the lung to contact the focus directly in COVID-19 patients Phase 0 clinical, Exocrine group:13; Control group:13; Aerosol inhalation of exosomes Lung CT, Nucleic acid detection of the pharyngeal test, Leukocytes and lymphocytes in blood routine
China ChiCTR2000030484 HUMSCs and Exosomes Treating Patients with Lung Injury following Novel Coronavirus Pneumonia (COVID-19) Phase N/A clinical. Treatment group 30 and control group 30. HUMSCs intravenous infusion, 5 × 10 (Lu et al., 2020) cells / time, once / week, twice / course; Exosomes: intravenous administration, 180 mg/time, 1 time/day, 7 days PaO2/FiO2 or respiratory rate (without oxygen), The number and range of lesions indicated by CT and X-ray of the lung, Time for the cough to become mild or absent. Inflammatory cytokines (CRP / PCT / SAA, etc.)
Samara, Russian Federation, 443,095 NCT04491240 Explore the safety and efficiency of aerosol inhalation of the exosomes in the treatment of severe patients hospitalized with novel coronavirus pneumonia. Clinical Trial, three groups, each with 30 subjects (n = 90). All eligible study subjects are randomized, double-blinded, to either the two treatment groups or placebo group 1. Safety assessment such as adverse events will be registered. Adverse events will be monitored during all trial
2. Safety assessments such as adverse events during the inhalation procedures will be registered.
No Contacts or Locations Provided NCT04493242 Evaluation of the safety and efficacy of intravenous administration of bone marrow-derived extracellular vesicles, ExoFlo, versus placebo as a treatment for moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) in patients with severe COVID-19. Multi-center, placebo-controlled, randomized clinical trial. 60 participants, 1. All-cause mortality
2. Median days to recovery