Table 2.
Adverse events up to Day 28
| Phase Ia | Phase Ib | Total, n | |||||
|---|---|---|---|---|---|---|---|
| Cohort I (n = 3) | Cohort II (n = 3) | Cohort III (n = 6) | Cohort IV (n = 3) | Cohort A (n = 3) | Cohort B (n = 6) | ||
| Adverse event | 0 | 1 | 2 | 1 | 3 | 3 | 10 |
| Relationship to MSCs treatment | |||||||
| Definitely related | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Probably related | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Possibly related | 0 | 0 | 1 | 0 | 1 | 2 | 4 |
| Unlikely to be related | 0 | 1 | 1 | 1 | 2 | 1 | 6 |
| Not related | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Severity level | |||||||
| Level 1 | 0 | 0 | 1 | 1 | 0 | 2 | 4 |
| Level 2 | 0 | 1 | 1 | 0 | 2 | 1 | 5 |
| Level 3 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Level 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Level 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse events resulted in death | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Categories | |||||||
| Rash | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
| Fever | 0 | 0 | 0 | 0 | 0 | 2 | 2 |
| Upper respiratory tract infection | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Influenza-like symptoms | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Kidney calculi | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Diarrhea | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Hemorrhoids | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Bleeding gums | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Adverse events outcome | |||||||
| Recovered | 0 | 0 | 0 | 1 | 3 | 0 | 4 |
| Improvement | 0 | 1 | 2 | 0 | 0 | 3 | 6 |
| Persistence | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Aggravation | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sequelae | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 |