Table 1 Clinical studies of MSCs treatment for patients with COVID-19
Reference/Trial ID | Trial design | Indications | Source of MSCs | Dose of MSCs | Route and time of administration | Number of patients | Findings |
|---|---|---|---|---|---|---|---|
ChiCTR2000029606 Tang L, et al.37 | Case report | ARDS | Allogeneic, menstrual blood-derived | 1 × 106 cells/kg, | IV 3 rounds (day 0,1,3) | 2 | Fraction of inspired O2 (FiO2) and partial pressure of oxygen (PO2) improved, well-tolerated. |
ChiCTR2000029990 Leng Z, et al.36 | Phase 1, open label, single center, Case-control | Moderate/Severe/Critical | MSCs | 1 × 106 cells/kg, | IV 1 round | 10 | The pulmonary function and symptoms were significantly improved after MSC transplantation. |
NCT04252118 Meng F, et al.38 | Phase 1, open label, single center, case-control | Moderate/Severe | Umbilical cord | 3 × 107 cells/dose | IV 3 rounds (day 0, 3 and 6). | 18 | Intravenous UC-MSCs infusion in moderate and severe COVID-19 patients is safe and well-tolerated. |
NCT04348461 Sánchez-Guijo F, et al.44 | Phase 1, prospective nonrandomized open-label cohort | Severe/Critical | Adipose-derived | 1 × 106 cells/kg | IV 1, 2 or 3 rounds | 13 | No adverse events were reported. Improvement in ventilatory, radiological and biological parameters was associated with clinical response. |
ChiCTR2000031494 Shu L, et al.46 | Phase 1, open-label, randomized, standard treatment-controlled trial | Severe/Critical | Umbilical cord | 2 × 106 cells/kg | IV 1 round | 41 | MSCs induced the clinical improvement. |
National Medical Products Administration of China Wu J, et al.35 | Phase 1, prospective, nonrandomized, open-label cohort | COVID-19 patients with lung fibrosis | hESC-IMRCs | 3 × 106 cells/kg | IV 1–3 rounds | 27 | Lung fibrosis lesions were decreased. |
IRCT20200217046526N2 Hashermian SR, et al.39 | Phase 1 | ARDS | Umbilical cord and placental | 2 × 108 cells/round | 3 rounds ((day 0, 2 and 4). | 11 | MSCs can improve respiratory distress and reduce inflammatory biomarkers in some critically illness with well tolerance. |
NCT04355728 Giacomo Lanzoni, et al.48 | Double‐blind, randomized, phase 1/2a, trial | ARDS | Umbilical cord | 10 ± 2 × 107 cells/round | IV 2 rounds (day 0 and 3) | 24 | UC‐MSC infusions were safe. Inflammatory cytokines were decreased significantly, and patient survival was improved. |
NCT04288102 Shi L, et al.47 | Phase 2, randomized, double-blind, placebo-controlled trial. | Severe | Umbilical cord | 4 × 107 cells/dose | IV 3 rounds (day 0, 3 and 6). | 100 | UC-MSCs administrations were safe and exerted improvement in whole lung lesion volume compared with the placebo, especially in solid-component lesion. The 6MWD showed an increased distance in patients treated with UC-MSCs. |
Local ethics approval Helene Helene Häberle, et al.45 | Phase 1 | Severe COVID-19 ARDS | Bone marrow-derived mononuclear cells | NA | NA | 23 | MSC infusion was safe. The MSC group had a significantly higher Horovitz score on discharge than the control group. |