“A six-month GLP study in baboons was performed using labeled allogeneic baboon ceMSC to evaluate the safety and immunogenicity following IV administration of 5x106 cells/kg on Day 1”
✓ VerifiedFDA pharmacology/toxicology review, p. 3Source ↗
Pivotal GLP studies
GLP rat single-dose IV (x2), 90-day rat repeat-dose IV (13 doses), 6-month baboon single IV; GLP rat pulmonary and pig cardiac safety pharm
“In a GLP repeat dose toxicity study, rats received 2x106 , 10x106 or 20x106 rat ceMSC/kg administered in a 5mL/kg dosing volume by tail vein injection over a two-minute period”
✓ VerifiedFDA pharmacology/toxicology review, p. 3Source ↗