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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.”

Professor Graziella Pellegrini, Coordinator of cell therapy at CMR, as well as director of R&D and co-founder of Holostem, who authored, together with Professor De Luca, the research and designed the product development explained how the technology works: “After developing cell cultures based on epithelial stem cells for the treatment of various disorders of the stratified epithelia – from the skin for full-thickness burns to the reconstruction of the urethra – we discovered that the stem cells that allow the regeneration of the cornea reside in a small area at the border between the cornea (the transparent part at the center of the eye) and the conjunctiva (the contiguous white part), which is called ‘the limbus’.

“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 areable to reconstruct in a laboratory the epithelium that covers the corneal surface, thanks to the stem cells harvested through a 1-2mm² 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/herself.”

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