Estudo da segurança de aplicação tópica de membranas de nanocelulose bacteriana modificadas com Poli-L-Lisina-Colesterol: teste clínico fase I

Abstract

The present study proposal aimed to analyze the safety of topical application of a new biomaterial for the treatment of skin lesions, composed of bacterial nanocellulose (NCB) membranes incorporated with the polymer Poly-L-Lysine-Cholesterol (PLC), here referred to as NCB-PLC. The NCB-PLC device features a novel modification on the NCB surface using the adsorption of the newly synthesized PLC polymer to enhance the adhesion and proliferation efficiency of epithelial cells, essential characteristics in the use of biomaterials in tissue engineering, especially for the treatment of extensive skin lesions. This biomaterial has already been characterized and its in vitro biocompatibility tested in epithelial cells. It was possible to observe the absence of toxicity, as well as good cellular adaptation, as evidenced by increased proliferation and adhesion of cells cultured on its surface. Preclinical in vivo trials (efficacy) were also previously conducted using an experimental skin excision model in C57BI/6 mice. The results indicated satisfactory wound healing action of the membrane under study, demonstrating its potential for wound treatment applications. In this regard, for clinical characterization and future availability of the NCB-PLC biomaterial in the market, the present research developed a safety test for its topical application, involving the analysis of a Phase I clinical study in human participants with intact skin who volunteered for the research. The study commenced after approval by the Ethics and Human Research Committee, and demographic data were collected through a form. Subsequently, material collection for hematology, biochemical tests, and urinalysis was performed before and 30 days after the initiation of NCB and NCBPLC membrane applications, which were applied three times a week on intact skin for one month. The statistical analysis results of adverse effects variables related to membrane application and laboratory tests suggest the potential for topical application of the membrane due to the absence of inflammatory response associated with its use. Therefore, it is necessary to proceed with the development of the study by conducting Phase II clinical trials.