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29 Dec 2014 3 Comments

First stem cell product made with patient’s own stem cells approved for treatments in Europe Union

Holoclar, an advanced therapy medicinal product (ATMP) containing stem cells has been approved by the European Medicines Agency (EMEA) for the treatment of Limbal Stem Cell Deficiency (LSCD) a condition caused by physical or chemical burns to the eye in adults. This is the first time that a stem cell therapy has been approved in European Union for widespread medical use.

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 (clear front part of the eye) and the sclera (white of the eye). These cells are important for regenerating and healing damage to the outer layer of the cornea (corneal epithelium). Physical or chemical burns can cause loss of these stem cells, resulting in LSCD, a condition that is estimated to affect about 3.3 out of 100,000 people in the European Union. Symptoms include pain, photophobia (painful sensitivity to light), inflammation, corneal neovascularisation (excessive ingrowth of blood vessels into the cornea), loss of corneal transparency, and eventually blindness.

Chiesi Farmaceutici S.p.A., Italy has manufactured Holoclar, which is a living tissue equivalent intended to be transplanted in the affected eye(s) after removal of the altered corneal epithelium. It is made from a biopsy taken from a small undamaged area of the patient’s cornea and grown in the laboratory using cell culture.

The decision by the EMA means the therapy can move beyond a limited research or case-by-case setting and be offered far more widely. Enrica Alteri, the head of the Human Medicines Evaluation Division at the EMA said: "This recommendation represents a major step forward in delivering new and innovative medicines to patients."



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