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Parma/Modena (Italy), February 20, 2015 – 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.
UnderlyingHoloclar® are more than twenty years of excellence in research, conducted by a team of internationally renowned scientists in the field of epithelial stem cell biology aimed at clinical translation. European Directive 1394/2007 substantially equalizes advanced cell therapies to medicines and imposes, among other things, that cell cultures has to be manufactured only in GMP-certified facilities (GMP: Good Manufacturing Practice). Thanks to the investments of Chiesi Farmaceutici, the Centre for Regenerative Medicine in Modena – where Holostem operates – was certified as GMP compliant and continue to follow the path towards the registration of this newly developed advanced therapy.
Via Krishan Maggon
When thermal or chemical burns of the ocular surface damage irreversibly this stem cell reserve, the corneal surface – which in a healthy eye completely renews itself approximately every six/nine months – stops regenerating and the conjunctiva gradually begins to cover the cornea with a white coating, that prevents vision and causes chronic pain and inflammation. If in at least one of the eyes of the patient even a small residue of undamaged limbus is left, we are able to reconstruct in laboratory the epithelium that covers the corneal surface, thanks to the stem cells harvested through a 1-2 mm2 biopsy. This graft of epithelium – Holoclar®, precisely – that looks like a kind of contact lens, is then transplanted into the patient and allows to obtain a long-term transparent cornea and a full recovery of visual acuity, without causing any rejection reaction, because it consists of cells of the patient him/hersel