Table 1.
Clinical studies of MSCs treatment for patients with COVID-19.
| Clinical trial ID | Study design | Phase | MSCs’ source | Indications | Dose and route of administration | N | General outcomes |
|---|---|---|---|---|---|---|---|
| ChiCTR2000029990[22] | Open label, single center, case-control | Phase 1 | MSCs | Moderate/Severe/Critical | 1 round of 1 × 106 cells/kg, IV | 7 | Markedly ameliorated symptoms and pulmonary dysfunction. |
| NCT04355728[23] | Double‐blind, randomized trial | Phase 1/2a | Umbilical cord | ARDS | 2 rounds of 10 ± 2 × 107 cells/round on days 0 and 3, IV | 24 | Safety for UC-MSCs, significantly reduced proinflammatory cytokines and improved patient prognosis. |
| NCT04288102[24] | Randomized, double-blind, placebo-controlled trial | Phase 2 | Umbilical cord | Severe | 3 rounds of 4 × 107 cells/dose on days 0, 3 and 6, IV | 100 | Safety for UC-MSCs, improved overall lung lesion volume, solid-component lesion. |
| ChiCTR2000031494[25] | Open-label, randomized, standard treatment-controlled trial | Phase 1 | Umbilical cord | Severe/Critical | 1 round of 2 × 106 cells/kg, IV | 41 | Clinical improvement following MSCs delivery |
| NCT04252118[26] | Open label, single center, case-control | Phase 1 | Umbilical cord | Moderate/Severe | 3 rounds of 3 × 107 cells/dose on days 0, 3 and 6, IV | 18 | Safe and well-tolerated intravenous administration of UC-MSCs to patients with moderate and severe COVID-19. |
| IRCT20200217046526N2 [27] |
Phase 1 | Placental and umbilical cord | ARDS | 3 rounds of 2 × 108 cells/round on days 0, 2 and 4, IV | 11 | Relieved respiratory distress and decreased inflammatory biomarkers by MSCs. | |
| NCT04348461[28] | Prospective nonrandomized open-label cohort | Phase 1 | Adipose-derived | Severe/Critical | 1, 2 or 3 rounds of 1 × 106 cells/kg, IV | 13 | No adverse events, amelioration of biological, radiological and ventilatory parameters correlated to clinical response. |
| National Medical Products Administration of China[90] | Case report | Allogenic, UC-MSCs |
Critical | 3 rounds of 5 × 107 cells/dose, IV | 1 | Remission of inflammation symptom, good tolerance, improved patient prognosis. | |
| ChiCTR2000029606[91] | Case report | Allogeneic, menstrual blood-derived | ARDS | 3 rounds of 1 × 106 cells/kg on days 0, 1 and 3, IV | 2 | Improved and well-tolerated partial pressure of oxygen (PO2) and fraction of inspired O2 (FiO2). | |
| National Medical Products Administration of China[92] | Prospective nonrandomized open-label cohort | Phase 1 | hESC-IMRCs | COVID-19 patients with lung fibrosis | 1–3 rounds of 3 × 106 cells/kg, IV | 27 | Reduced pulmonary fibrotic lesions. |
ARDS acute respiratory distress syndrome; hESC-IMRCs human embryonic stem cell-derived immunity and matrix-regulatory cells; IV intravenous injection; MSC mesenchymal stem cell; UC-MSCs umbilical cord mesenchymal stem cells; 6MWD 6-minute walking distance