Europe approves stem cell therapy

A stem cell treatment for severe cornea damage has been granted conditional approval by the European commission. Holoclar is the first stem cell therapy to be approved in the EU, as well as the first approved treatment for limbal stem cell deficiency.

Holoclar has been developed by Holostem Advanced Therapies, a spin-out from the University of Modena and Reggio Emilia, Italy, in partnership with Chiesi Pharmaceuticals. It uses tissue grown from a biopsy of the patient’s own cells to replace the epithelium in patients whose eyes have been damaged by physical or chemical burns, and lack sufficient limbal stem cells to properly regenerate that tissue.

‘The authorisation process has been long and complex, but shows that cells can be cultured according to pharmaceutical standards appropriate to guarantee safety and efficacy,’ said Michele De Luca, scientific director and co-founder of Holostem.