Evaluation of the stability and efficacy of rhGM-CSF as a topical agent in a gel formulation.

OBJECTIVE

It has been reported that recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF), applied as a solution or an emulsion, improves wound healing. In order to confirm these data, the wound-healing efficacy of this growth factor was studied in a murine model.

METHOD

In this double-blind randomised study, murine excisional wounds were treated with either sterilised rhGM-CSF gel (10 micrograms/cm2) or a sterilised placebo gel (control group). rhGM-CSF was applied at dosages of 10 micrograms/cm2/day to wounds until complete closure occurred.

RESULTS

rhGM-CSF stability in gel formulation was excellent during the first week but decreased thereafter. Full wound healing occurred within 9.7 days (mean time) in the intervention group compared with 10 days in the control group. This difference was not statistically significant. Histological evaluation of the healed wounds indicated that there was a similar percentage of neutrophils in the cellular infiltrate in both groups.

CONCLUSION

rhGM-CSF sterile gel had an excellent safety profile and was easy to use, but did not significantly accelerate the healing rate in this model.