An eye treatment is set to be the first stem cell therapy approved for routine use in Europe, it has been announced.
The treatment has been developed for limbal stem cell deficiency, a condition often caused by physical and chemical burns.
The European Medicines Agency says the stem cell therapy should be agreed as a first-line treatment for the disease and as an alternative to donor tissue transplant.
The treatment, known as Holoclar, involves taking a biopsy to collect cells from an undamaged area of eye. These are then grown in the laboratory using cell culture.
The European Medicines Agency says the treatment should get conditional approval as there is not yet comprehensive proof, from trials, that the benefits of the treatment outweigh the risks.
Enrica Alteri, of the EMA, said: “This recommendation represents a major step forward in delivering new and innovative medicines to patients.
“It is an advanced therapy medicinal product that has been designated as an orphan medicine.”
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