Michele De Luca received his MD at the University of Catania and his specialization in Endocrinology at the University of Rome and is elected member of the European Molecular Biology Organization and the Accademia dei Lincei, Italy. Graziella Pellegrini received her master degrees in Chemistry and Pharmacy at the University of Genova and is founding member of the International Ocular Surface Society. Currently, they are full professors of Biochemistry (M.D.L.) and Cell Biology (G.P.) and coordinators of Cell (G.P.) and Gene (M.D.L.) Therapy at the Center for Regenerative Medicine of the University of Modena and Reggio Emilia. They are co-founders, members of the Board, Scientific Director (M.D.L.), and Director of Research & Development (G.P.) of Holostem Terapie Avanzate S.r.l., Modena, Italy.
Michele and Graziella have dedicated their scientific activities to translational medicine and have been a driving force in the development of epithelial stem cell-mediated cell and gene therapy. Following on from early work on the use of human epidermal stem cell cultures in life-saving treatment of massive full-thickness burns and in repigmentation of stable vitiligo and piebaldism by keratinocyte/melanocyte co-culture, they were the first to establish human urethral stem cell culture aimed at urethral regeneration in posterior hypospadias. They have characterized molecular mechanisms regulating long-term proliferative potential, clonal evolution, and self-renewal of epithelial stem cells. These findings led to the use of limbal cultures for corneal regeneration in patients with severe limbal stem cell deficiency due to massive chemical burns of the ocular surface. This treatment allows recovery of normal vision and received marketing authorization from the European Medicine Agency (Holoclar). Michele and Graziella are also pioneering ex vivo epidermal stem cell-mediated combined cell and gene therapy for genetic skin diseases. They coordinated the first successful clinical trial to treat junctional epidermolysis bullosa (JEB). They have recently reported life-saving regeneration of the entire, fully functional, epidermis on a 7-year-old child suffering from a devastating, life-threatening form of JEB and showed that the human epidermis is sustained only by a limited number of long-lived stem cells detected as holoclones. They have received numerous awards, including the 2018 International Society for Stem Cell Research (ISSCR) Innovation award (co-awarded), International Prize “Lombardia è ricerca” (co-awarded), Kazemi Award for Research Excellence in Bio-Medicine 2018 (M.D.L.), Eurordis Black Pearl Award 2018 (M.D.L.), Italian Government Award “Le Ragioni della Nuova Politica” 2017 (G.P.), Prix Galien Award Netherlands 2016 and Prix Galien Award United Kingdom 2016 for Holoclar, MIT technology Review Italia “Smart & Disruptive Companies 2015” (co-awarded), ISSCR Public Service Award 2014 (M.D.L.), Biennal Award “A.I.R.C.M.O.” (Italian Association for Research and Treatment of Ocular Pathologies) 2002 (G.P.).