Table 1 Clinical studies of MSC treatment for COVID-19 patients
From: Redressing the interactions between stem cells and immune system in tissue regeneration
Trial ID | Trial design | Indications | MSC source | Dose and routes of MSC administration | Number of patients | Clinical outcomes | Refs |
|---|---|---|---|---|---|---|---|
ChiCTR2000029990 | Phase 1, open-label, single-center, case–control | Moderate/Severe/Critical | Clinical grade MSCs | 1 × 106 cells/kg, i.v | 10 | The pulmonary functions and symptoms were significantly improved after MSC infusion. | 101 |
ChiCTR2000031494 | Phase 1, open-label, randomized, standard treatment–control | Severe/Critical | Umbilical cord | 2 × 106 cells/kg, i.v | 41 | MSC infusion showed improved clinical manifestations. | 102 |
NCT04252118 | Phase 1, open-label, single-center, case–control | Moderate/Severe | Umbilical cord | 3 × 107 cells/dose, i.v | 18 | Intravenous MSC infusion in moderate and severe COVID-19 patients was safe and well-tolerated. | 103 |
NCT04269525 | Phase 2, case–control | Severe/Critical | Umbilical cord | 1 × 108 cells/dose, i.v | 16 | MSC infusion showed improvement in ventilatory, radiological and biological parameters. No MSC infusion related adverse or allergic reactions and no delayed hypersensitivity or secondary infections were reported. | 104 |
NCT04288102 | Phase 2, randomized, double-blind, placebo-control | Severe | Umbilical cord | 4 × 107 cells/dose, i.v | 100 | MSC infusion was safe and exerted improvement in total lung lesion proportion and solid component lesion. There was an increased 6-min walking distance in MSC group. | 105 |
NCT04348461 | Phase 1, prospective nonrandomized open-label cohort | Severe/Critical | Adipose tissue | 1 × 106 cells/kg, i.v | 13 | No MSC infusion-associated adverse events were reported. Improvement in ventilatory, radiological and biological parameters was associated with clinical status. | 106 |
NCT04355728 | Phase 1/2a, randomized, double-blind | ARDS | Umbilical cord | 10 ± 2 × 107 cells/dose, i.v | 24 | MSC infusion was safe. The levels of pro-inflammatory cytokines were significantly decreased, and patient survival and recovery time were improved. | 107 |
IRCT20200217046526N2 | Phase 1 | ARDS | Umbilical cord and placental | 2 × 108 cells/dose, i.v | 11 | MSC infusion in critical illness COVID-19 patients was safe and well-tolerated. MSC group had improved respiratory distress and reduced inflammatory signatures. | 108 |