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. Author manuscript; available in PMC: 2011 Aug 1.
Published in final edited form as: Am Heart J. 2010 Aug;160(2):215–223. doi: 10.1016/j.ahj.2010.03.029

Table 4.

Final BMMNC Product Release Criteria Testing

  • 1. Product Release Criteria

Negative Gram stain
Viability: >70% by Trypan Blue exclusion
Target cell dose: 0.8 −1.1 ×10e8
Endotoxin: <5.0EU/kg recipient weight

  • 2. Supplementary Testing by Cell Processing Centers

Aerobic and Anaerobic sterility by blood culture method
CFU-GM colony growth
Immunophenotyping CD34+/CD45+ cells