The first stem-cell therapy has been approved by European regulators in a major step forward for advanced medicine in Britain. The European Medicines Agency (EMA) has recommended Holoclar, viagra a treatment in which a patient’s own healthy stem cells are used to grow new cells which are then transplanted into the eye.
It is a major step forward for stem-cell therapies which have so far being confined to the lab and clinical trials. Experts predicted advanced treatments will be available on the NHS within a few years.
“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,” Professor Graham McGeown, Reader in Physiology, Centre for Experimental Medicine, Queen's University Belfast.
“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.”
Stem cells can act as a repair system for the body.
Limbal stem cells are located in the eye at the border between the cornea – the clear front part of the eye - and the sclera – the white of the eye.
Physical or chemical burns can cause loss of these stem cells, resulting in limbal stem cell deficiency, LSCD, a condition that is estimated to affect about 3.3 out of 100,000 people in the European Union and around 650 people in Britain.
Symptoms include pain, sensitivity to light, inflammation, excessive blood vessel growth, clouding of the cornea, and eventually blindness.
In LSCD the limbal stem cells become so diminished that they eyes can no longer make new cells to repair damage.
The new treatment takes a small sample of the patients healthy cornea, removes the stem cells and grows them until there are sufficient numbers to put back into the eye. The cells themselves then repair the damage.
Moorfields Eye Hospital in London has successfully treated around 20 people with Holocar so far in trials.
Prof Chris Mason, from University College London, told the BBC: "This move would enable far more people to access it, you could now prescribe this."
The EMA decision to approve Holoclar will now be sent to the European Commission for market authorization. It will then be up to Nice to decide whether to approve the therapy for use on the NHS.
Dr Dusko Ilic, Reader in Stem Cell Science, King's College London, said: “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.”
Holoclar, has been developed by the Italian pharmaceutical company Chiesi Farmaceutici S.p.A.
Enrica Alteri, Head of EMA’s Human Medicines Evaluation Division said the decision represented a ‘major step forward’ for stem cell therapies.
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