Research Article

The Manufacture of GMP-Grade Bone Marrow Stromal Cells with Validated In Vivo Bone-Forming Potential in an Orthopedic Clinical Center in Brazil

Table 4

Purity and safety analysis of the BMSCs.

Anaerobic and aerobic bacteria

BMSC 05ND0.57<0.0057.43
BMSC 06ND0.43<0.0050.04
BMSC 07ND0.33<0.0050.04
BMSC 08ND0.42<0.0050.03
BMSC 09ND1.08<0.0050.04
BMSC 10ND0.82<0.0050.05
BMSC 11ND0.37<0.005ND
BMSC 12ND0.47<0.005ND
BMSC 13ND0.63<0.022ND
BMSC 14ND0.70<0.005ND

ND: not detected. Assessed in the cell supernatant during sample collection, BMSC isolation, and expansion (passages 0 and 2). Assessed in the supernatant from passage 2 BMSCs. Assessed in the supernatant from passage 2 BMSCs washed for 5 cycles with Ringer’s lactate solution containing 0.5% human albumin to reduce the residual level of bovine contaminants.