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Abstract Introduction: Type 1 Diabetes mellitus (T1DM) is an autoimmune disorder which arises from the destruction of insulin-producing pancreatic β-cells. Currently, Brazil’s advanced therapy medicinal products (ATMP), developed for clinical research and therapeutic purposes, take place in the so-called Cellular Technology Centers (CTC), according to the Resolution nº. 9/2011 of the Collegiate Board of Directors (RDC), enacted by the National Health Surveillance Agency (Anvisa). Objective: This study was conducted with the main objective of describing and discussing the development of ATMP for T1DM treatment. Method: A qualitative research, narrative review and critical discussion of the literature were under taken. Results: ATMP promote new therapeutic approaches for Diabetes, holding great potential to restore the patients’ endogenous insulin secretion, improving their life quality, overcoming the chronic complications of Diabetes and reducing the socioeconomic burden. Nowadays, ATMP in T1DM comprise: a) cell therapy; b) gene therapy products; c) tissue engineering and d) ATMPassociated to biopharmaceutical products. Conclusions: Further research should contribute to stimulate public and private organizations to effectively act towards reducing the impact of Diabetes on individuals and the society as a whole. It is essential that Brazilian legislation closely follows the biotechnological developments, supporting the scientific progress and benefiting T1DM patients with modern and cutting-edge therapies. Author Biography Mari Cleide Sogayar, Chemistry Institute, Biochemistry Department, University of São Paulo Mari Cleide Sogayar - Productivity fellowship/research award (CNPq ? Level 1A ) 1968: BS in Biological Sciences (University of São Paulo Biosciences Institute); 1973: Master´s degree (MsSci ? University of California San Diego, Biology Dept.), 1977: PhD in Biochemistry (University of São Paulo Chemistry Institute); 198201984: Visiting Assistant Professor (Harvard Medical School, Dana Farber Cancer Institute). 1980: University of São Paulo Chemistry Institute (Assistant Prof.) 1987: University of São Paulo Chemistry Institute (Associate Prof.) 2000 - 2013: Biochemistry Dept., University of São Paulo, Chemistry Institute (Full Professor) 2013 ? present: Internal Medicine Dept., University of São Paulo, Medical School (Senior Professor) Research area: Biochemistry, with emphasis in Cell Biology, Molecular Biology and Biotechnology. Research themes: a) cell proliferation control and the origin of neoplasia, using genomics, transcriptomics, functional genomics and proteomics; b) stem cells differentiation aiming at tissue regeneration and repair; c) cell therapy based on both adult and stem cells applied to degenerative diseases (clinical human pancreatic islet transplantation in hyperlabile type 1 diabetic patients) and tissue engineering; d) production of recombinant proteins in heterologous expression systems (bacteria, mammalian cells and the baculovirus/insect cells system) for production of recombinant biopharmaceuticals, such as: human prolactin, human leptin, human and bovine follicle stimulating hormone-FSH, human amylin/IAPP, human clotting factors (FVIII, FIX and von Willebrand), human Bone Morphogenetic Proteins-BMPs for bone repair, human platelet-derived growth factor ? PDGF, human vascular endothelial growth factors ? VEGFs, human basic fibroblast growth factor ? hbFGF, human granulocyte and granulocyte and macrophage colony-stimulating factors ? hG- and hGM-CSFs, hR-Spondin, among others. e) Supervised 41 PhD and 14 MsSci students and more than 30 post-doctoral fellows; offered training to over 40 undergraduate students. f) Coordinates the activities of the Cell and Molecular Therapy translational research Center (NUCEL) of the University of São Paulo (www.usp.br/nucel)

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