Evaluation of nanocomposite (carbon-graphene) associated with mesenchymal stem cells for reconstruction of maxillofacial bone defects

Abstract

The cleft lip and palate (CLP) is the most common congenital craniofacial malformation seen at birth. In order to eliminate the morbidity of the bone donor region, improve the quality of life of patients with CLP and reduce the cost involved in treating these patients, several bone tissue bioengineering strategies have been developed. In Brazil, our research group, through the development of Tissue Bioengineering project for patients with craniofacial malformations (PROADI-SUS (25000.009809/2018-65) used stem cells from deciduos teeth pulp associated with a biomaterial, in clinical studies, to reconstruct the alveolar bone of patients with CLP and we were successful using this bone tissue bioengineering strategy to close the alveolar bone cleft (clinicaltrial.gov: NCT01932164 and NCT03766217; Tanikawa et al, 2020). However, the biomaterial used in this project has a slow reabsorption and for patients with CLP it would be ideal to use a biomaterial that can be reabsorbed more quickly and preferably at a lower cost. Therefore, the aim of the this study is to carry out the translational medicine phase to test the effectiveness of the use of genuinely Brazilian biomaterials, with low cost, fast reabsorption, projecting a future use of it in bone tissue bioengineering for the treatment of patients with CLP. The potential of alveolar bone formation will be evaluated using carbon / graphene biomaterials (scaffolds) alone and also associated with mesenchymal stem cells from the pulp of human deciduos teeth. This study will be carried out in medium-sized animals, mini pigs, with the approximate weight of a children with CLP at the age of alveolar bone graft. The costs to produce carbon biomaterial with and without graphene will be compared and a cost-effectiveness analysis will be carried out. As an outcome of this project, it is expected to find an ideal material for the treatment of the CLP patients by tissue bioengineering that has faster reabsorption and lower cost compared to the imported biomaterial (Bio-Oss Collagen®, Geistlich) that has been used for bioengineering of alveolar bone tissue of patients with CLP in Brazil (PROADI-SUS Project 25000.009809/2018-65 triennium 2018-2020). To achieve our goals we will combine the expertise of the POLI-USP materials engineering team in the development of carbon / graphene biomaterials with the expertise of the Sírio-Libanês Hospital team over stem cells procedures in order to develop a new tissue bioengineering strategy for a future use in clinical studies. In addition, we will count on the collaboration of researchers from CNPEM and the University of California Los Angeles to analyze the tissue bioengineering strategies and the new created bone. (AU)