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

From: Mesenchymal stem/stromal cell-based therapies for severe viral pneumonia: therapeutic potential and challenges

Study type/patient cohort Intervention Outcomes measured Reference/trial number
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