NICE recommends Holoclar (ex vivo expanded autologous human corneal epithelial cells containing stem cells) to treat severe limbal stem cell deficiency -Chiesi Farmaceutici SPA

The National Institute for Health and Care Excellence (NICE) has recommended Holoclar (ex vivo expanded autologous human corneal epithelial cells containing stem cells) from Chiesi Farmaceutici SPA, as as an option in people with moderate to severe limbal stem cell deficiency after eye burns.

The recommendation from NICE provides that Holoclar can only be used to treat one eye and if the patient has already had a conjunctival limbal autograft (or there is not enough tissue for a conjunctival limbal autograft or it is contraindicated). This decision is for Europe's first approved stem cell medicinal product. A single treatment for one eye costs £80,000 excluding VAT, and the company has agreed a patient access scheme with the Department of Health, with a confidential discount.

Comment; Holoclar, manufactured by Holostem Advanced Therapies (a spin-off of the University of Modena and Reggio Emilia), was approved in Europe in February 2015.It is a graft of epithelium taken from the patient that looks like a contact lens which is then transplanted, allowing them to obtain a long-term transparent cornea and full recovery of visual acuity, without any rejection concerns.