Monday, 22 December 2014
Europe recommends approval for first stem-cell therapy
(Reuters) - European regulators have recommended approval of the first medicine containing stem cells to treat a rare condition caused by burns to the eye.
The European Medicines Agency said on Friday that Holoclar, from privately held Italian company Chiesi, had been given a green light for moderate to severe limbal stem cell deficiency due to physical or chemical burns. Left untreated, the condition can result in blindness.
Holoclar is a living tissue product made from a biopsy taken from a small undamaged area of the patient’s cornea and grown in the laboratory using cell culture.
The recommendation by the European agency will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization.