First stem-cell therapy recommended for approval in EU

Mar 3, 2015

The European Medicines Agency (EMA) has recommended Holoclar, the first advanced therapy medicinal product (ATMP) containing stem cells, for approval in the European Union. Holoclar is a treatment for moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eye(s) in adults. It is the first medicine recommended for LSCD, a rare eye condition that can result in blindness.

EMA Press release here.