Skip to main content
. Author manuscript; available in PMC: 2019 Jun 8.
Published in final edited form as: Circ Res. 2018 Apr 27;122(12):1703–1715. doi: 10.1161/CIRCRESAHA.118.312978

Table 5.

Quality Control Tests on Thawed, Washed Cell Product at Center Cell Processing Labs

Assay Test Method Specification
Rapid Sterility* Gram Stain No organisms seen (negative)
Viability* Trypan Blue ≥70%
Endotoxin* EndoSafe PTS ≤ 5EU/kg†
Aerobic, Anaerobic, and Fungal 14 day Bactec/BacT/ALERT assay or equivalent No Growth
Cell Count – CPCs* Manual Minimum 0.8×106 final dose
Maximum 5×106 final dose
Cell Count – MSCs* Manual Minimum 75×106 final dose
Maximum 150×106 final dose
*

Tests done for release criteria specification prior to injection; for cell counts, the product must meet the minimum count for release

†

Based on recipient weight and product volume