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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