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 is manufactured by Holostem Terapie Avanzate (Holostem Advanced Therapies) – a spin-off of the University of Modena and Reggio Emilia – at the Centre for Regenerative Medicine “Stefano Ferrari” (CMR) of the same University.

“Holoclar is the very first medicinal product based on stem cells to be approved and formally registered in the Western world” – states Andrea Chiesi, Director of R&D Portfolio Management of Chiesi Farmaceutici S.p.A. and CEO of Holostem Terapie Avanzate. “This record – continues Andrea Chiesi – shows that the partnership between the public and private sectors is not only possible, but is probably the best strategy for the development of stem cell-based regenerative medicine, particularly when autologous cells are used. Holostem is now considered as a business model to translate into clinics the results obtained by scientific research in this field”.

For more details, go to: http://www.chiesigroup.com/en/europe-approves-holoclar®-the-first-stem-cell—based-medicinal-product-