Table 5.
Primary outcome: safety.
| References | Treatment-related adverse events | Treatment-related serious adverse events |
|---|---|---|
| Meng et al. (18) | Two patients in the MSC group developed fever and transient facial flushing immediately on infusion, which resolved spontaneously within 4 h. Another patient with the moderate disease had a transient fever (38°C) within 2 h that resolved within 24 h | None |
| Häberle et al. (19) | None | None |
| Leng et al. (20) | No acute infusion-related, allergic reaction, delayed hypersensitivity, or secondary infection was detected | None |
| Nesrin et al. (21) | No adverse effects were observed related to infusion or allergic reactions, secondary infection, or life-threatening adverse events in MSC patients | None |
| Xu et al. (22) | 54 AE occurred in 20 of 26 MSC group, and 56 AE occurred in 18 of 18 control group during the whole trial | None |
| Giacomo et al. (23) | No definite or probable TR-AE in both groups. The only reported adverse event in the MSC group occurred in a patient with bradycardia, who experienced aggravating of bradycardia and needed transient vasopressor treatment | None |
| Lei et al. (24) | No MSC-related predefined respiratory or hemodynamic adverse events were observed. The incidence of adverse events during the whole trial was similar between the MSC group (55.38%) and the control group (60%) | None |
| Shu et al. (25) | All MSC group patients had no adverse reactions (such as rash, allergic reaction, and febrile reaction after infusion) | None |
| Gina Marcela Torres et al. (26) | None | None |
| Dynasty (27) | None | None |
AE, adverse event; h, hour; MSC, mesenchymal stem cell; SAE, severe adverse event; TR-AE, treatment-related adverse event.