Safety reports during the trial including AEs and the one SAEs
| Subject | Non-serious AEs (#NCI-CTCAE Grade) | SAE (#) | AEs related to MSCs | Early withdrawal |
| 1 | 3 grade 1 5 grade 2 0 grade ≥3 | 0 | Grade 2 nausea (‘possible’) | |
| 2 | 0 grade 1 2 grade 2 0 grade ≥3 | 0 | ||
| 3 | 2 grade 1 2 grade 2 0 grade ≥3 | 1 | Grade 1 paraesthesias (‘possible’) Grade 1 flushing (‘possible’) | Dropped out after week 8 visit |
| 4 | 0 grade 1 3 grade 2 0 grade ≥3 | 0 | Grade 2 tachycardia (‘possible’) | |
| 5 | 1 grade 1 1 grade 2 0 grade ≥3 | 0 | ||
| 6 | 1 grade 1 1 grade 2 0 grade ≥3 | 0 | ||
| Total | 21 AEs | 1 SAE | 4 AEs possibly treatment related; all resolved without sequela | 1 early withdrawal to pursue other SLE treatments at week 8 |
There were no grade 3 or higher AEs. AEs deemed definitely not related to the investigational product are totalled numerically but not detailed in the table. Attribution of the AEs and SAE is presented in column 3.
AEs, adverse events; MSCs, mesenchymal stromal cells; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; SAE, serious adverse event.