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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.
(Reporting by Ben Hirschler; editing by Jason Neely)
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