Table 3.
Clinical outcomes and adverse events
| Infant 1.1 | Infant 1.2 | Infant 1.3 | Infant 2.1 | Infant 2.2 | Infant 2.3 | |
|---|---|---|---|---|---|---|
| Infusion reaction | No | No | No | No | No | No |
| Infection within 14 days of infusions | No | No | No | No | No | No |
| Need for inhaled nitric oxide | No | No | No | No | No | No |
| Need for extracorporeal membrane oxygenation | No | No | No | No | No | No |
| Length of stay (initial hospitalization) | 9 | 10 | 9 | 9 | 9 | 9 |
| Discharge home on anti-epileptics | No | No | No | No | No | No |
| Discharge home requiring NG-GT feedings | No | No | No | No | No | No |
| Re-hospitalizations, first 2 months | No | No | No | No | No | No |
| Blood-related adverse events | *No | No | No | No | No | No |
| PRA, first test result (age in months) |
Negative (6) | Negative (7) | Negative (6) | Negative (6) | Negative (2) |
Negative (2) |
| PRA, last test result (age in months) |
Positive class II (17) |
Positive class II (14) |
Positive class I and II (15) |
Refused testing | Positive class I & II (7) |
Negative (15) |
The sample obtained from the thawed hCT-MSC aliquot for the first subject’s dose had a positive gram stain and culture for coagulase-negative Staphylococcus, which was assessed to be a contaminant after review by the study team, the site IRB, and the FDA.