The first stem cell therapy for use in the European Union has been approved, which will be used for a condition which can result in blindness.
Prof. Graham McGeown, Reader in Physiology, Centre for Experimental Medicine, Queen’s University Belfast (QUB), said:
“Light entering the eye first passes through a clear layer of cells known as the cornea. Damage to the eye from burns or toxic chemicals can lead to a number of problems, including a reduced ability of the cornea to repair itself by producing healthy new corneal cells. This can occur because the specialised cells that divide and mature to replace old or damaged corneal cells, known as limbal stem cells, are so reduced in number that they cannot produce adequate numbers of replacement cells. The new treatment takes a small sample of the patient’s healthy cornea, isolates the limbal stem cells from it and then grows under carefully controlled artifical conditions until there are enough to put back onto the eye. This can help prevent further corneal damage and loss of sight. When there is already extensive damage, use of this stem cell treatment may also help a corneal graft to heal more quickly.
“This is exciting both because there are no other treatments for this sort of damage to the eye and because this is the first example in which a ‘medicine’ based on stem cells has been approved for use in humans. Because the cells come from the patient themselves, there should be no worries that the body will reject them as can happen when using a transplant from another person. This treatment will only be allowed under carefully defined conditions, however, so that the outcomes can be carefully monitored to see if the treatment works and doesn’t have any unexpected side-effects.”
Dr Dusko Ilic, Reader in Stem Cell Science, King’s College London, said:
“This news did not come as a surprise. The therapeutic approach on which Holoclar is based is relatively well established and it was just a question of when it would be approved by regulatory agencies. It has been performed in multiple academic institutions around the world, including the UK. I hope that Holoclar is not just an exception, and that many more cellular therapy products will see market in the next year.”