Green light in Europe for first stem cell therapy
The European Medicines Agency’s main scientific committee is recommending approval of a stem cell therapy to treat limbal stem cell deficiency. It is the first positive opinion for a stem cell therapy and the fifth for an advanced therapy medicinal product (ATMP).
The European Medicines Agency’s main scientific committee is recommending approval of a stem cell therapy to treat limbal stem cell deficiency. It is the first positive opinion for a stem cell therapy and the fifth for an advanced therapy medicinal product (ATMP).
The EMA announced the opinion on 19 December, which will now go to the European Commission for a decision on marketing authorisation. The agency is recommending a conditional marketing authorisation, which would give the product market access, but subject to the supply of additional clinical data. The developer is Chiesi Farmaceutici SpA of Parma, Italy.
The product, Holoclar, is a living tissue equivalent which is intended to be transplanted into an eye which has been damaged following a physical or chemical injury. When such an injury occurs, there is damage to the limbal stem cells which are located at the border between the cornea and the sclera. The cells are responsible for repairing damage to the corneal epithelium. At worst, the loss of these cells can lead to blindness.
Holoclar is made from a biopsy taken from an undamaged area of the patient’s cornea and grown in the laboratory using a cell culture. According to the EMA, the product can act as an alternative to conventional transplantation. It reduces the risk of rejection compared with transplanting tissue from a donor and does not require surgery on the patient’s second eye as only a small biopsy is performed to collect the target cells. As a consequence, the therapy may also be suitable where both eyes are affected by moderate to severe limbal stem cell deficiency.
Holoclar is the first medicine to be recommended for limbal stem cell deficiency.
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