Cell therapy process otimization for wound healing treatment in patients: biodressing development and evaluation of therapeutic potential of keratinocytes, fibroblasts and mesenchymal cells in chronic ulcers and severe burns

• Grant number: 16/16013-2
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: March 01, 2017
• End date: February 29, 2020
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Carolina Caliári Oliveira
• Grantee: Carolina Caliári Oliveira
• Company: In Situ Terapia Celular Ltda
• Associated researchers: Maria Beatriz Puzzi ; Paula Tavares Colpas
• Associated research grant: 15/01067-7 - Regenerative medicine using either keratinocytes and fibroblasts or melanocytes to cellular therapy in wound healing from distinct etiologies and vitiligo, AP.PIPE
• Associated research grant(s): 25/03004-4 - "Production of clinical batches of the 3D Biocurativo Mesencure¿ in compliance with ANVISA regulations for the evaluation of its safety and efficacy profile in patients with pressure injuries (PI).", AP.PIPE; 21/03817-4 - Safety and efficacy evaluation of 3D biodressing containing mesenchymal cells in patients with complex wounds, AP.PIPE
• Associated scholarship(s): 18/14651-7 - Cell therapy for wounds: biodressing development and therapeutic potential of mesenchymal cells for wound healing in chronic wounds and burns, BP.TT; 18/09550-7 - Cell therapy for wounds: biodressing development and therapeutic potential of mesenchymal cells for wound healing in chronic wounds and burns, BP.TT; 17/05419-0 - Cell therapy process otimization for wound healing treatment in pacients: biodressing development and evaluation of therapeutic potential of keratinocytes, fibroblasts and mesenchymal cells in chronic ulcers and severe burns, BP.PIPE

Abstract

The skin is the largest human organ and has important functions like protection, thermal regulation and prevention of body dehydration. Thus, the loss of skin integrity could be responsible for several complications. Currently, the increase in life expectancy in humans has been associated with an increase in the incidence of chronic wounds, commonly associated with venous and arterial insufficiency and neuropathies; it may also be associated with diabetes. Chronic and severe wounds such as those caused by extensive burns are challenging specialists to deal with, leading to long treatment time and high costs for health systems. Burns are the five most commons accidents in Brazil, in national health system are treated 2300 burns of month. Therapeutic alternatives are already available for the treatment of extensive burn wounds and chronic wounds, however, there is a therapeutic hiatus represented by patients in which these conventional therapies are not effective. In this sense, in recent years, cell therapy has demonstrated to be promising. In pre-clinical and clinical studies, therapy using autologous skin cells such as keratynocites and fibroblasts or mesenchymal cells have already shown good results by speeding the wound and burns treatment. Therefore, the objective of the present project is the optimization of cell therapy process, development of biodressing with cells and to assess the therapeutic potential of the the co-administration of queratinocytes and fibroblasts or mesenchymal cells in patients with chronic wounds from distinct etiologies and burns. The results of this research project could provide new insights to wound healing therapies in patients with chronic ulcers and burns. (AU)