Holoclar, the first stem cell-based medicinal product approved in Europe

The European Commission has granted a conditional marketing authorization, under Regulation (EC) No 726/2004, to Holoclar, an advanced therapy based on autologous stem cells and capable to restore the eyesight of patients with severe cornea damage.

Holoclar, developed by privately-held Italian drugmaker Chiesi Farmaceutici and Holostem Terapie Avanzate, is an advanced-therapy medicinal product (ATMP) granted orphan designation for limbal stem cell deficiency (LSCD) caused by chemical or physical burns. Holostem is a spin-off of the University of Modena and Reggio Emilia – at the Center for Regenerative Medicine “Stefano Ferrari” (CMR) of the same University.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation on Holoclar for the treatment of moderate to severe limbal stem cell deficiency due to physical or chemical burns to the eyes in adults late last year.