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Our pipeline is based on the pivotal work of Michele De Luca and Graziella Pellegrini in the field of epithelial stem cell-mediated cell and gene therapy.
Graziella Pellegrini and Michele De Luca were first in establishing human autologous 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 this limbal stem cell therapy as an Orphan Medicinal Product and in 2015 the European Commission has granted to Holoclar® a conditional marketing authorization. Holoclar® is the first medicinal product based on stem cells to be approved and formally registered.

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.

Our Company

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 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.


Our scientist are author of over 150 peer-reviewed publications in major international journals.

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