Development of biofunctional materials for application in regenerative medicine, tissue engineering and advanced therapy of bone defects

• Grant number: 18/18890-6
• Support type: Research Grants - Innovative Research in Small Business - PIPE
• Duration: December 01, 2019 - November 30, 2021
• Field of knowledge: Interdisciplinary Subjects
• Principal Investigator: Daniel Navarro da Rocha
• Grantee: Daniel Navarro da Rocha
• Company: R-Crio Criogenia S/A
• CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: Campinas
• Co-Principal Investigators: Jheison Lopes dos Santos
• Assoc. researchers: André Antonio Pelegrine ; Angela Maria Moraes ; Camila Cristine Lopes ; Carla Cristina Gomes Pinheiro ; Cecília Buzatto Westin ; Daniela Franco Bueno ; Rubens Lincoln Santana Blazutti Marçal
• Associated research grant: 17/08198-5 - Development of composites membranes for guided bone regeneration (GBR), AP.PIPE

Abstract

Guided bone regeneration technique is an important clinical strategy to regenerate bone tissue through the use of occlusive membranes, which preserve the bone graft at the site and prevent the bone defect from being invaded by fast growth tissues (fibrous or epithelial) [1,2]. During bone tissue regeneration, membranes must maintain its structural integrity to support bone formation and maturation. This approach is mainly used in regeneration of major bone defects in maxillofacial, periodontal and orthopedic surgeries. In PIPE - PHASE 1 project, the incorporation of a bioactive component (calcium phosphate) into the polymer membrane had the objective to improve the biological response without loss of its mechanical properties, proven through in vitro tests, and cited in interviews such as a greater need of medical professionals. As a continuity of work, in PIPE - PHASE 2, the increase in quantity and quality of bone defects regeneration will be investigated through preclinical tests on critical-sized calvarial bone defects in Wistar rats and bilateral alveolar defects in mini pigs. In addition to composite membranes, R-Crio Criogenia aims to develop synthetic porous scaffolds associated with mesenchymal stem cells (MSC) and/or extracellular vesicles (EV), comparing to commercial porous scaffolds - the control group. Preclinical and clinical studies indicates that the immunomodulatory and differentiation capacity of MSC may influence the bone regeneration process and the quality of the new bone formed. In addition, as in other cells, MSC releases vesicles with bioactive charges into the extracellular medium that act as mediators in intercellular communication, disseminate biological information and contribute to paracrine factors. It is essential, for future clinical research (humans), to prove the safety and efficacy of biomaterials associated with MSC and EV, through preclinical studies in small (Wistar rats) and medium-sized (mini pigs) animal models. For the proper registration and commercial development of the tissue engineering product/process, clinical studies phase 1 and phase 2 will be carried out, together with ANVISA, during PIPE - PHASE 3. (AU)