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 and gene therapy.

Beside their pioneering work on the use of human epidermal stem cell cultures in life-saving treatment of massive full-thickness burns (hundreds of patients treated in collaboration with several burn units) and in repigmentation of stable vitiligo and piebaldism (approximately one hundred patients treated in Italy), they were first in permanently regenerating a functional urethral epithelium – by means of cultured urethral stem cells – in patients suffering from posterior hypospadia and an oral epithelium – by means of cultured oral mucosa stem cells – in patients with defects of the gingival epithelium.

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.