Holostem is the first biotechnological company entirely devoted to development, manufacture, registration and distribution of Advanced Therapies Medicinal Products (ATMPs) based on cultures of epithelial stem cells both for cell and gene therapy.Holostem Terapie Avanzate was born in 2008 as a university spin-off thanks to the profitable union among the Key Opinion Leaders like Michele De Luca and Graziella Pellegrini, the innovative spirit of the University of Modena and Reggio Emilia and the industrial know-how of Chiesi Farmaceutici S.p.A., a leading Italian pharmaceutical company.
On the 12th December 2023, Fondazione Enea Tech e Biomedical, a private foundation supervised by the Italian Ministry of Enterprises and Made in Italy, has formally completed the acquisition of Holostem S.r.l. including all assets and operations.
Holostem has a highly experienced management team, with a sound know-how derived from a long tenure both in business administration and in academic research, successfully applied since many years in translational medicine.
Michele De Luca and Graziella Pellegrini are internationally recognized as leading scientists in the field of epithelial stem cell biology aimed at clinical application in Regenerative Medicine and played a pivotal role in epithelial stem cell-mediated cell therapy and gene therapy.
Graziella Pellegrini and Michele De Luca were first in establishing human limbal stem cell culture aimed at corneal regeneration in patients with severe limbal stem cell deficiency due to massive thermic and chemical burn-dependent destruction of the cornea. This treatment led to recovery of vision in hundreds of patients with poor or no alternative therapy. In August 2008, the European Medicines Agency (EMA) designated their limbal stem cell therapy as an Orphan Medicinal Product and in 2015 the European Commission has granted to Holoclar® a conditional marketing authorization.
Michele De Luca and Graziella Pellegrini established in 2006 a proof of principle of the feasibility of ex-vivo gene therapy for laminin 332-dependent Junctional Epidermolysis Bullosa (JEB) by means of transplantation of autologous epidermal sheets prepared from genetically corrected epidemal stem cells.
