Table 1 Investigational medicinal product (IMP) specification
S. no | Description | Specifications | |
|---|---|---|---|
1 | Morphology | Cells are fibroblastic and spindle-shaped in active growing conditions Cells are intact and round in shape after trypsin action | |
2. | Cell count | 180 to 220 million cells per bag | |
3. | Viability | ≥85% | |
4. | Cell phenotype | CD 73 >80% CD105 > 80% CD 90 > 80% CD 166 > 80% | CD 34 <5% CD 45 < 5% CD 133 < 5% CD 14 < 5% CD19 < 5% HLA-DR < 5% |
5. | Karyotyping | Normal, 46 XY | |
6. | Mycoplasma PCR ELISA | Not detected | |
7. | Sterility test | Must comply | |
8. | Differentiation assay to adiopocyte, osteocyte, and chondrocyte | Confirmation of differentiation | |