Table 3 Randomized controlled clinical trials of MSC therapy for COVID-19

Phase 2

Severe COVID-19 induced ARDS (n = 100, 2:1 ratio)

UC-MSCs (VCANBIO)

4 × 10⁷ MSCs × 3 infusions

Improvement in whole lung lesion volume, no difference in SAEs

Shi et al. [117]

NCT04288102)

Phase 1/2a

Mild–moderate and moderate–severe COVID-19 induced ARDS

(n = 24, 1:1)

UC-MSCs + Heparin

1 × 10⁸ MSCs × 2 infusions

No infusion associated AEs or SAEs, inflammatory cytokines decreased, improved patient survival, and time to recovery

Lanzoni et al. [118]

NCT04355728

Phase 1

Critically ill COVID-19 patients

(n = 40, 1:1)

UC-MSCs + standard care

1 × 10⁶ MSC/kg

Improved survival rate, no changes in ICU stay or ventilator use, no AEs reported. IL-6 reduced

Dilogo et al. [119]

NCT04457609

Phase 3

Moderate-to-severe COVID-19 induced ARDS (n = 223, 1:1)

BM-MSCs (Remestemcel-L)

2 × 10⁶ MSC/kg × 2 infusions

30-day all-cause mortality, ventilator-free days, adverse events, 7-day mortality, ARDS resolution

NCT04371393

Ongoing

Phase 1/2

Moderate-to-severe COVID-19 induced ARDS

(n = 120, 1:1)

UC-MSCs (Orbcell-C)

Max tolerated dose established in Phase 1

Oxygenation Index, SAE incidence

NCT03042143

Ongoing