Research Article
Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy
Table 6
Summary cell recovery according to processing phase.
| | Batch # | Number of total cells after selection (×106) | Number of cells sampled for all QC test (×106) | Number of frozen cells for QC retesting (×106) | Number of cells shipped for clinical use (×106) |
| | PTC-CD133-052 | 20.63 | 3.55 | 4.5 | 12.58 | | PTC-CD133-055 | 8.16 | 2.18 | 0.54 | 5.44 | | PTC-CD133-068 | 7.98 | 1.35 | 0.79 | 5.84 | | PTC-CD133-085 | 6.92 | 1.84 | 0.58 | 4.5 | | PTC-CD133-090 | 5.16 | 1.62 | 0.69 | 2.85 | | PTC-CD133-098 | 11.22 | 2.62 | 1.12 | 7.48 | | PTC-CD133-109 | 40.14 | 3.73 | 5.58 | 30.84 | | PTC-CD133-116 | 17.82 | 2.77 | 1.62 | 13.43 |
| | Mean | 14.75 | 2.46 | 1.93 | 10.37 | | Standard Deviation | 11.61 | 0.87 | 1.97 | 9.08 | | Median | 9.69 | 2.40 | 0.96 | 6.66 | | Minimum Value | 5.16 | 1.35 | 0.54 | 2.85 | | Maximum Value | 40.14 | 3.73 | 5.58 | 30.84 |
|
|
Number of cells obtained after CliniMACS selection and overnight storage in X-Vivo15.
|
