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Table 1 Acceptance criteria of the automatically generated cell product (CP)

From: GMP-conformant on-site manufacturing of a CD133+ stem cell product for cardiovascular regeneration

Validation no. No. of viable CD133+cells (×106) in 5 ml Cell viability [%] Depletion of non-target cells [−log CP]
1 1.0 97.92 3.86
2 0.28 77.17 2.82
3 0.57 71.42 2.60
4 0.19 87.13 3.46
5 0.12 77.66 3.49
6 0.97 87.53 3.17
Mean 0.52 83.14 3.23
SEM 0.16 3.90 0.19
Acceptance range 0.05–5 × 106 ≥70% ≥2.5 log
  1. Number of viable CD133+ cells and cell viability of the automatically generated CP were analyzed by flow cytometric analysis in accordance with ISHAGE guidelines. Depletion of non-target cells was calculated as the negative logarithm to base 10 of number of total CD133+ cells in CP divided by the number of CD133+ cells in bone marrow. All data are presented as mean ± SEM