International Journal of Stem Cells : eISSN 2005-5447

Table. 2.

Table. 2.

Ongoing clinical trials of exosomes derived from MSCs or other cell types for COVID-19 therapy before February 26, 2021

Study ID EVs source Delivery mode EVs dose Study phase;
participant (n)
Outcomes
NCT04602442 N/A Inhalation 0.5-2×1010 exosome/3 ml, twice a day for 10 days II; n=90

Adverse events

TTCR

Blood biochemistry

SpO2 concentration changes

Chest imaging changes

NCT04491240 MSC Inhalation 0.5-2×1010 exosome/3 ml, twice a day for 10 days I & II; n=90

Adverse events

TTCR

Blood gases changes

SpO2 concentration changes

Chest imaging changes

NCT04389385 T cells Inhalation 2×108 exosome/3 ml; daily for 5 days I; n=60

Adverse events

TTCR

Rate of recovery without a mechanical ventilator

NCT04384445 Human amniotic fluid Intravenous infusion 2-5×1011 exosome/1 ml, day 0, day 4, and day 8 I & II; n=20

Adverse events

60-day mortality

Survival rate

Levels of cytokines, D-dimer, CRP

Viral load

Improved organ failure

Chest imaging changes

NCT04493242 Bone marrow Intravenous injection N/A II; n=60

28-day mortality

Median days to recovery

NCT04276987 MSC Inhalation 2×108 exosome/3 ml, daily for 5 days I; n=30

Adverse events

TTCR

Number of patients weaning from mechanical ventilation

Days of ICU monitoring

Days of vasoactive agents’ usage

Days of mechanical ventilation

Number of patients with improved organ failure

28-day mortality

NCT04747574 T-RExTM-293 cells Inhalation 1×109 exosome/2 ml, daily for 5 days I; n=30

Adverse events

Survival at Day 5

SpO2 saturation measurement

Respiratory rate measurement

Proportion of patients with no artificial ventilation

Change in the absolute lymphocyte count from baseline

Change in neutrophil-to-lymphocyte ratio

ISRCTN 33578935 Placental MSC Intravenous infusion 0.2 mg/kg, 15 ml, on day 1 and day 3 II; n=64

Adverse events

PaO2/FiO2 ratio

IRCT20200510047385N1 Condition media of SVF and blood Injection into the patient’s lungs through the trachea 10 ml daily for 3 days II & III; n=60

SOFA score

Lung damage score

Inflammatory status (IL1, IL6)

Oxidative status (TAC)

ChiCTR 2000030261 MSC Inhalation N/A N/A; n=26

Lung CT

Nucleic acid detection of pharyngeal test

Leukocytes and lymphocytes count

ChiCTR 2000030484 N/A Intravenous injection 180 mg/day, for 7 days N/A; n=90

Adverse events

PaO2/FiO2 or respiratory rate (without oxygen)

Frequency of respiratory exacerbation

Physical signs and symptoms

TTCR

The number and range of lesions indicated by CT and X-ray of the lung

Time for the cough to become mild or absent

Time for dyspnea to become mild or no dyspnea

Frequency of oxygen inhalation or noninvasive ventilation

Frequency of mechanical ventilation

Inflammatory cytokines (CRP/PCT/SAA, etc.)

Abbreviations: EVs: Extracellular vesicles, TTCR: Time to clinical recovery, SVF: stromal vascular fractions, CRP: C-reactive protein, PCT: Procalcitonin, SAA: serum amyloid A, HAF: human amniotic fluid, TAC: total antioxidant capacity, SOFA: Sequential Organ Failure Assessment.

International Journal of Stem Cells 2021;14:252-61 https://doi.org/10.15283/ijsc20182
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