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Development and validation of medical devices, biological compounds and cell therapies

Introduction

Several lines of research are active in the laboratory, aimed at the characterization and evaluation of the clinical potential of: medical devices such as visco-supplementation products; biological compounds such as platelet rich plasma (PRP), bone marrow concentrate and adipose tissue concentrate; cells isolated from various sources, alone or in combination with biomaterials supplied externally or made by the laboratory itself by 3D printing. Primary monolayer cultures are obtained from different types of human and animal tissue (mononuclear cells, mesenchymal cells of different derivation such as bone marrow, adipose tissue, bone tissue etc., chondrocytes, osteoblasts, synoviocytes, tenocytes, ligament cells) and subsequently characterized from a proliferative, phenotypic and functional point of view, both in basal conditions and inducing differentiation in chondrogenesis, osteogenesis, etc.. Cellular and/or tissue cultures are prepared even under experimental conditions different from those shown: in tri-dimension, in pellets, under regulated oxygen tension conditions and under controlled mechanical stimulations through the use of a bioreactor. The preclinical optimization of the constructs can be performed both in static and dynamic systems (e.g. Flexercell and Bioreactors). Structural and morphological evaluations are also performed through histological analysis and evaluations in optical microscopy and image analysis. These activities are aimed at the evaluation of tissues engineered for transplantation for the regeneration of osteo-cartilaginous tissues, the definition of molecular mechanisms underlying some joint diseases and the performance of preclinical tests for the validation of molecules with potential therapeutic relevance.

 

Figure 1: Preparation of a cell culture; characterization; monolayer or 3D culture under static or dynamic (bioreactor) conditions; functional assays.

 

Figure 2: Characterization of biological compounds (PRP, PRF, APS) and their activity on cell cultures (chondrocytes, synoviocytes, mesenchymal cells)