Europe has approved the Western world's first medicine containing stem cells to treat a rare condition caused by burns to the eye, marking a milestone in the use of the technology.
Holoclar, from privately held Italian company Chiesi, was given a marketing green light on February 20, by the European Commission for treating so-called limbal stem cell deficiency due to physical or chemical burns. Left untreated, the condition can result in blindness. The stem-cell therapy is a living-tissue product. It resembles a contact lens and is made from a biopsy taken from a small undamaged area of a patient's cornea and grown in the laboratory using cell culture.
The conditional marketing authorisation had been expected, following a positive recommendation by the European Medicines Agency in December.
Chiesi said the approval meant that Holoclar would be available "in the near future" to all suitable patients in Europe, including people who have suffered eye injuries caused by solvents, acids, abrasive and chemical agents."
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