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Europe's first marketing approval for stem cell product granted

2 March 2015
Appeared in BioNews 792

The European Commission has given conditional marketing approval to a stem cell-based therapy for the first time. Clinical availability still depends on pending decisions in European Union (EU) member states but the treatment, called Holoclar, is on course to restore vision to thousands of patients with severe eye damage.

'Holoclar is the very first medicinal product based on stem cells to be approved and formally registered in the Western world,' confirmed Andrea Chiesi, director of R&D portfolio management at Chiesi, the pharmaceutical company that developed the treatment.

Holoclar is aimed at treating limbal stem cell deficiency (LSCD), a rare eye condition affecting around three in 100,000 adults in the EU. LSCD most often occurs after damage from physical or chemical burns to the eye.

Holoclar is a living-tissue product, a 'lens' that can be fashioned out of autologous - the patient's own - stem cells.

A healthy eye normally renews itself every six-to-nine months using limbal stem cells (LSCs), found between the cornea (the clear front layer of the eye) and the sclera (the white of the eye). When these cells are damaged it can lead to scarring and eventually blindness.

With Holoclar, the LSCs from the patient are used in the laboratory to create a cornea that is transplanted back into the eye. In trials it has been used along with corneal transplants to improve outcome and can lead to full recovery of eyesight.

Professor Graziella Pellegrini, who was involved in the research and design of Holoclar, said: 'If in at least one of the eyes of the patient even a small residue of undamaged limbus is left, we are able to reconstruct in laboratory the epithelium that covers the corneal surface.'

Because the cells are the patient's own the risk of rejection is greatly reduced.

Holoclar's development began over 20 years ago. The European Medicines Agency recommended the treatment for approval in December (see BioNews 785).

At that time King's College London stem cell expert Dr Dusko Ilic said he hoped that Holoclar was 'not just an exception, and that many more cellular therapy products will see market in the next year'.

Chiesi gains a pioneering marketing OK for stem cell therapy
Fierce Biotech |  23 February 2015
Europe approves Holoclar, the first stem cell-based medicinal product
Chiesi (press release) |  20 February 2015
Europe approves Western world's first stem-cell therapy for rare eye condition
Reuters |  20 February 2015
Europe okay for first stem-cell therapy - Chiesi's Holoclar
Pharma Times |  20 February 2015
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