Table 2.
Clinical trials using allogeneic umbilical cord-derived mesenchymal stromal cells for COVID-19-related ARDS and cerebral palsy
| Authors | Disease | Phase | Patients number | Age (range) year | Cell number | Frequency, interval | Results | Adverse event | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| COVID-19-related ARDS | ||||||||||||
| Monsel A., et al. [18] (2022) | Moderate to severe COVID-19-related ARDS | 2b | MSC: 21, placebo: 24 | 64 (mean) | 1 × 106 cells/kg | Day 0, day 2 ± 1, day 4 ± 1 | No efficacy of PaO2/FiO2-ratio and mortality | No SAE | ||||
| Dilogo IH., et al. [19] (2021) | Critically ill COVID-19-related ARDS | 2 | MSC: 20, placebo: 20 | < 40:4, 40–60: 8, > 60: 8 | 1 × 106 cells/kg | One dose | Survival rate in UC-MSCs group was 2.5 times higher (P = .047), that in UC-MSCs group with comorbidities, 4.5 times higher. The length of stay in the intensive care unit and ventilator usage were not statistically significant | No AE | ||||
| Gorman EA., et al. [20] (2023) | Moderate to severe COVID-19-related ARDS | 2 | MSC: 30, placebo: 29 | 58.4 (mean) | 4 × 108 cells | One dose | Improvement of pulmonary organ dysfunction: no difference | Safe and well tolerated | ||||
| Lanzoni G., et al. [21] (2021) | Mild to severe COVID-19-related ARDS | 1/2 | MSC: 12, placebo: 12 | 58.6 (mean) | 100 ± 20 × 106 cells | Day 0, day3 | Survival rate at day 28: MSC 91, placebo 42%, P = .015), SAE-free survival (P = .008), time to recovery (P = .03) | No SAE, no difference in AEs | ||||
| Farkhad NF., et al. [22] (2022) | Mild to moderate COVID-19-related ARDS | 1 | MSC:10, control: 10 | 62.0 (mean) | 1 × 106 cells/kg | Day 0, day 2, day 4 | Improvement of patients’ clinical and paraclinical parameters (leukocytosis, lymphopenia, thrombocytopenia, liver enzyme abnormalities) | no SAE | ||||
| Shaz BH., et al. [23] (2023) | COVID-19-related ARDS | 1 | 10 | 39–79 | 1 × 106 cells/kg, maximum dose 108 cells | Once a day for 3 days | Survival on day 28, 7 (70%) | No SAE | ||||
| Neonatal encephalopathy | ||||||||||||
| Cotten CM., et al. [24] (2023) | Moderate to severe hypoxic ischemic encephalopathy, treated with hypothermia | 1, pilot | 6 | 36–41 weeks | 1 or 2 doses of 2 × 106 cells/kg/dose | First dose: during hypothermia, second dose: 2 months later | All babies survived, with average to low-average developmental assessment standard scores between 12 and 17 postnatal months | Well tolerated, low titer anti-HLA antibodies by 1 year of age: 5/6 | ||||
All MSCs were injected intravenously
Day 0 the first administration day
AE adverse event, ARDS acute respiratory distress syndrome, COVID-19 coronavirus infectious disease emerged in 2019