Introduction

Since the discovery of epidermal growth factor (EGF) in the early 1960s, extensive research has been devoted to elucidating its mechanisms of action and exploring its potential applications. EGF plays a pivotal role in cell growth, proliferation, and differentiation by binding to the EGF receptor. It stimulates the growth and healing of epithelial tissues. With the advent of recombinant DNA technology, it became possible to produce recombinant human EGF (rhEGF) at an industrial scale, opening up new possibilities for research and clinical applications.

Recombinant Human (EGF) Mechanism of Action

EGF exerts its effects by binding to the EGF receptor (EGFR), a transmembrane glycoprotein that possesses intrinsic tyrosine kinase activity. Binding of EGF to EGFR leads to receptor dimerization and autophosphorylation of tyrosine residues in the cytoplasmic domain of the receptor. This activates several downstream signaling pathways such as Ras-Raf-MAPK, PI3K-Akt, and PLCγ pathways. These pathways regulate a variety of cellular responses like cell proliferation, survival, differentiation, migration, and metabolism. EGF particularly stimulates the proliferation of epithelial cells and enhances epithelial wound healing.

Potential Clinical Applications of Recombinant Human (EGF)

Given its potent mitogenic, motogenic and proliferative effects on epithelial cells, rhEGF holds promise for accelerating wound healing and regeneration in various clinical situations. Some of the potential therapeutic applications are discussed below:

Skin wound healing: Topical application of recombinant human (EGF) has shown to significantly speed up the healing of various skin wounds like pressure ulcers, diabetic ulcers, burns, and surgical wounds in several clinical trials. It stimulates granulation tissue formation, re-epithelialization and tissue remodeling during wound repair.

Gastrointestinal mucosal repair: As rhEGF accelerates the regeneration of gastrointestinal epithelium, it has been used to treat several gastrointestinal disorders associated with mucosal damage like inflammatory bowel disease, radiation enteritis, and necrotizing enterocolitis in newborns. It helps repair damaged mucosa and restore barrier function.

Lung epithelial repair: Preclinical studies indicate that rhEGF may facilitate alveolar epithelial repair and regeneration in acute lung injuries. It could potentially be used to treat acute lung diseases like pneumonia, acute respiratory distress syndrome, and bronchopulmonary dysplasia in very preterm infants.

Corneal wound healing: Topical rhEGF eye drops have shown to speed up corneal wound healing after refractive surgeries like LASIK and help repair defects caused by infection, trauma or burns. It promotes re-epithelialization of the cornea.

Other applications: Ongoing research also explores the potential of rhEGF in treating oral mucositis caused by chemotherapy or radiation therapy, regenerating vaginal epithelium after cancer treatment, repairing bladder mucosa in interstitial cystitis patients and stimulating hair follicle growth.

Commercial Products and Clinical Guidelines

Heberprot-P is a topical formulation of rhEGF developed and approved in Cuba for the treatment of diabetic foot ulcers. It is clinically proven to significantly reduce healing time and improve outcomes. Regranex gel, containing recombinant human PDGF-BB, is approved by the FDA for treating diabetic foot ulcers. However, rhEGF is not yet approved for any clinical uses in other countries. More research is still needed to establish its efficacy and safety for various wound types before firm clinical guidelines can be developed. Standardization of production methods, formulation development and large randomized clinical trials are important future steps.

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