Part 1: Cell number, Viability and Safety profile of formulated AstroRx cell product | ||||||||
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Cohort | Patient Number | Cell count (X106) | Cell viability (%) | Safety Profile | ||||
Bacteriology | Mycoplasma | Endotoxin level (EU/ml) | EPCAM (%) | SSEA4 (%) | ||||
A | 1001 | 102 | 93.9 | NC | NC | < 1.0 | 0.0 | 0.0 |
1002 | 90 | 95.5 | NC | NC | < 1.0 | 0.0 | 0.0 | |
1005 | 95 | 92.9 | NC | NC | < 1.0 | 0.0 | 0.0 | |
1008 | 102 | 91.9 | NC | NC | < 1.0 | 0.0 | 0.0 | |
1009 | 98.5 | 94.7 | NC | NC | < 1.0 | 0.0 | 0.0 | |
B | 2010 | 245 | 96.6 | NC | NC | < 1.0 | 0.0 | 0.0 |
2012 | 270 | 97.6 | NC | NC | < 1.0 | 0.0 | 0.0 | |
2015 | 258 | 96.6 | NC | NC | < 1.0 | 0.0 | 0.0 | |
2016 | 261 | 96.4 | NC | NC | < 1.0 | 0.0 | 0.0 | |
2017 | 265 | 95.6 | NC | NC | < 1.0 | 0.0 | 0.0 |
Part 2: Cell characteristics of formulated AstroRx® product | ||||
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Cell characteristics | Cohort (Average ± SEM) | Release Criteria | ||
A | B | |||
Astrocytic identity | CD44 (%) | 99.3 ± 0.2 | 99.8 ± 0.0 | ≥ 85% |
GLAST (%) | 88.8 ± 7.6 | 69.9 ± 1.3 | ≥ 50% | |
GFAP (%) | 97.5 ± 0.9 | 92.2 ± 1.3 | ≥ 70% | |
Potency | TIMP-1 (ng/106) | 38.2 ± 7.7 | 43.9 ± 6.1 | ≥ 5 ng/106 |
MIDKINE (ng/106) | 14.3 ± 1.3 | 19.9 ± 2.0 | ≥ 0.5 ng/106 |