Efeito de uma biomembrana de proteínas do látex de Calotropis procera (AIT.) R. BR na cicatrização: Estudos pré-clínico e clínico piloto

Abstract

Leprosy is an infectious disease of chronic evolution, its etiologic agent being Mycobacterium leprae, which shows affinity for cells of the peripheral nervous system and can cause primary deformities by compromising sensitive, motor and autonomic fibers, causing a decrease or absence of sensitivity, paralysis and amyotrophy. Secondary to this nervous damage can be calosities, fissures and plantar ulcers. There are several effective treatments for the treatment of plantar ulcers, but of extreme difficulty of acquisition due to the high cost. In this way, this work has as objective a search for a new therapeutical tool accessible for the treatment of plantar ulcers, conducting a pre-clinical study in vitro and clinical pilot. The biomembrane BioMem cplp is a biotechnological product consisting of the obtained isolated fraction of Calotropis latex procera has shown potential healing by stimulating the inflammatory phase of wound healing by stimulating the release of pro-inflammatory cytokines resulting in a remarkable improvement in the subsequent stages of the healing process. In vitro studies showed that CpLP is safe in the murine fibroblast (L929) line at concentrations below 3.12 μg / mL and concentrations of 0.78 and 1.56 μg / mL were able to increase cell viability. CpLP also induced the proliferation and migration of fibroblasts at concentrations of 0.78 and 1.56 μg / mL. For the pilot clinical study, 9 patients with 12 plantar ulcers resulting from leprosy were selected, which consisted of two groups: conventional treatment (Silver Sulfadiazine) and treatment with BioMem CpLP 10%. Patients treated with the biomembrane did not present hypersensitivity to the biomembrane by the patch test and had beneficial results in the treatment of plantar ulcer in the parameters of reduction of the area as well as reduction of necrosis and increase of reepithelialization. There was a significant increase in the contraction of the ulcer treated with the biomembrane after 60 days compared to the beginning of the treatment. Regarding the clinical evaluation of plantar ulcers, BioMem CpLP 10% was able to debride the devitalized tissue in 85.7% of the patients and presented an increase in cicatricial tissue formation in almost 86% of the ulcers while in ulcers treated with Sulfadiazine de the increase was 60%. The results presented support for the development of a clinical study that evaluates an effective and low cost therapeutic option available for patients with plantar ulcers.