Research Article
Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy
Table 1
Purity and viability of CD133+ cells (%) obtained in 8 batches of ATMP-CD133.
| Batch # | % CD133+ | Cell viability | Starting material | Final product (purity) | Starting material | Final product |
| PTC-CD133-052 | 1.87 | 96.2 | 95.83% | 96.03% | PTC-CD133-055 | 3.39 | 81.87 | 96.83% | 97.70% | PTC-CD133-068 | 0.86 | 94.61 | 95.27% | 99.87% | PTC-CD133-085 | 1.18 | 89.80 | 87.67% | 99.91% | PTC-CD133-090 | 0.41 | 81.40 | 96.62% | 99.75% | PTC-CD133-098 | 0.90 | 91.40 | 93.62% | 99.95% | PTC-CD133-109 | 1.21 | 93.64 | 96.28% | 99.97% | PTC-CD133-116 | 0.90 | 81.94 | 96.29% | 99.86% |
| Mean | 1.34 | 88.86 | 94.80% | 99.13% | Standard deviation | 0.93 | 6.21 | 3.06% | 1.47% | Median | 1.04 | 90.60 | 96.06% | 99.87% | Minimum value | 0.41 | 81.40 | 87.67% | 96.03% | Maximum value | 3.39 | 96.2 | 96.83% | 99.97% |
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