Table 2.
Specifications for preclinical construct and finished PeriCord human bioimplant.
| Preclinical construct | PeriCord human bioimplant | |
|---|---|---|
| Active ingredient | ||
| Viable cells | Porcine MSCs | Human WJ-MSCs |
| Density | 0·875 × 106/cm2 | (0·62–0·93) × 106/cm2 |
| Dose | 1·75 × 106 cells | (7–15) × 106 cells |
| Viability | ≥70% | ≥70% |
| Excipient | ||
| Definition | Vehicle | Vehicle |
| Hydrogel PuraMatrix™ | Hydrogel PuraStat™ | |
| Sucrose | Sucrose | |
| Phosphate buffered saline | Plasmalyte®®148 | |
| Vehicle | Decellularised, lyophilised, and irradiated human pericardium | Decellularised, lyophilised, and irradiated human pericardium |
| Vehicle size | 2 cm2 | 12–16 cm2 |
Note: MSCs, mesenchymal stromal cells; WJ-MSCs, Wharton's jelly mesenchymal stromal cells.