Recombinant production of human skin growth factor for effective treatments of hard-to-heal wounds

An estimated population of 400 million people is currently afflicted with Diabetes Mellitus (DM) worldwide. Among DM patients, 15% of them will develop a foot ulcer, which is a major complication of DM, and 15% of the patients with DM foot ulcers will require amputations. Consequently, DM patients account for half of the non-traumatic lower-limb amputations. The cost of diabetic foot care is unbelievably high; for example, an estimated cost of non-operative care of a single foot ulcer could be as high as US$ 7,000. In view of the difficulties and expensive costs of treating DM foot ulcers, in 2003, our team made use of recombinant human Epidermal Growth Factor (EGF), which was produced using our proprietary Escherichia coli excretion system, and conducted a double-blind randomized controlled study to investigate the efficacy of EGF in treating DM ulcers. The results revealed that EGF was highly effective in the treatments, with a high healing efficiency of 95% within a median time of six weeks, in comparison with 42.1% for non-EGF treatment over a period of 12 weeks. Our findings were reported in the June 2003 issue of Diabetes Care, and a PCT patent for the findings was granted in USA, China, Taiwan, Europe and Hong Kong. In this presentation, efficient expression systems, which have been employed to produce EGF and another important skin growth factor, human Basic Fibroblast Growth Factor (bFGF), will be introduced. The important properties of EGF and bFGF required to exert their bio-activities will also be discussed. Both EGF and bFGF may prove to be invaluable means exploited for cost-effective treatments of DM foot ulcers in the future.