One of the greatest needs in the clinical bone field is a bioactive agent t
o stimulate bone formation. We previously reported that fibroblast growth f
actor-2 (FGF-2) exhibited strong anabolic actions on bone formation in mode
ls of rodents and dogs. Aiming at a clinical application, this study was un
dertaken to clarify the effect of a single local application of recombinant
human FGF-S on fracture healing in nonhuman primates. After a fracture was
created at the midshaft of the right ulna of animals and stabilized with a
n intramedullary nail, gelatin hydrogel alone (n = 10) or gelatin hydrogel
containing 200 mug FGF-2 (n = 10) was injected into the fracture site. Alth
ough 4 of 10 animals treated with the vehicle alone remained in a nonunion
state even after 10 weeks, bone union was complete at 6 weeks in all 10 ani
mals treated with FGF-2. Significant differences in bone mineral content an
d density at the fracture site between the vehicle and FGF-S groups were se
en at 6 weeks and thereafter. FGF-S also in creased the mechanical property
of the fracture site. We conclude that FGF-2 accelerates fracture healing
and prevents nonunion in primates, and therefore propose that it is a poten
t bone anabolic agent for clinical use.