When talking to any scientist involved in the development, creation or application of Heberprot-P, aimed at treating patients with advanced diabetic foot ulcers, they all say one word: unique.
And for good reason; it is the only medicine in the world capable of stimulating faster granulation and re-epithelialization in diabetic foot ulcers, and it reduces the healing time of these lesions, thereby decreasing the number of debridements and the risk of amputation.
Developed by the Center for Genetic Engineering and Biotechnology (CIGB), its effectiveness has been seen for over 20 years and it has been registered by some 26 countries, improving the quality of life of 411, 275 patients treated with Heberprot-P globally.
The product reduces the relative risk of amputation in complex diabetic foot ulcers by more than 50%, provided that three essential premises are met: availability of the therapy, medical personnel trained in its use and political will to implement a program that involves the statistical follow-up of cases treated until lesions finally close, or failing that, amputation occurs.
Heberprot-P is applied three times a week on the relevant lesions. The active pharmaceutical ingredient is recombinant human epidermal growth factor, (FCEhrec) a 53 amino acid peptide, which binds to its cellular receptor to induce anabolic processes, promoting cellular division, differentiation and migration, important elements in the formation of effective granulation tissue. The method of application makes this treatment unique, as it is applied through perilesional and intralesional injections, infiltrating 75 ug of (FCEhrec) to avoid its degradation due to the bacterial biofilm and the action of proteases released in the cellular environment of the ulcer.
Work has already been done on new formulations to obtain superior results, as well as developing other applications.
The medicine is in microspheres or nanovesicles, protected from the proteases that exist in the damaged region and, therefore, the molecule lasts longer in the place where it acts and fewer applications are required.
It was in 1994 when the Cuban scientist Jorge Berlanga, a member of the healing group of the biomedical research area of the CIGB, developed a mouse model to study the use of epidermal growth factor in managing neuropathy, one of the complications of diabetes.
Research up to 2001 was devoted to demonstrating the efficacy and biosafety of the new therapy in animals, comparing the advantages of injecting epidermal growth factor over applying it topically to wounds.
Between 2001 and 2005, clinical trials II and III began and concluded in different national health system centers. By 2007, the medication was included in the basic list of medications for the management of DFUs. From that day to this, its widespread use within the country has become a norm, although the time has come for it to be considered not just an alternative in managing diabetic foot ulcers, but the therapeutic indication for managing this type of lesion
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