Table 2 Investigational Medicinal Product (IMP) specification
Description | Specifications | |
|---|---|---|
Morphology | Cells are fibroblastic and spindle shaped in active growing condition. | |
Cells are intact and round in shape after the trypsin action | ||
Cell count | 180 to 220 million cells per bag | |
Viability | > 85% | |
Cell phenotype | CD 73 > 80% | CD 34 < 5% |
CD105 > 80% | CD 45 < 5% | |
CD 90 > 80% | CD 133 < 5% | |
CD 166 > 80% | CD 14 < 5% | |
CD19 < 5% | ||
HLA-DR < 5% | ||