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Table 1 Investigational medicinal product (IMP) specification

From: Efficacy and safety of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (Stempeucel®): preclinical and clinical trial in osteoarthritis of the knee joint

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