Chiesi’s stem cell therapy approved in Europe
pharmafile | February 23, 2015 | News story | Research and Development, Sales and Marketing | Chiesi, EC, Europe, Holoclar, Holostem Advanced Therapies, LSCD, stem cell
Chiesi’s Holoclar has become the first stem cell therapy to get the green light in Europe, gaining conditional approval from the European Commission.
The therapy – manufactured by Holostem Advanced Therapies – is used to treat moderate to severe forms of limbal stem cell deficiency (LSCD), a rare eye condition caused by physical or chemical burns to the eye that can lead to blindness.
Chiesi says that Holoclar is “the very first medicinal product based on stem cells to be approved and formally registered in the Western world”.
The nod from the European Comission follows a recommendation by the CHMP in December last year. However, because the EMA has said that the submission data for Holoclar is based on retrospective studies that are not yet comprehensive, a full license is conditional on Chiesi conducting an additional study into the use of the treatment.
The therapy will be allowed to be marketed in the EU while these studies are being conducted.
“The authorisation process has been long and complex, but the result achieved shows that cells can be cultured according to pharmaceutical standards appropriate to guarantee safety and efficacy,” says Professor Michele De Luca, scientific director at Holostem.
“In addition, in a period of great confusion about the real therapeutic possibilities of stem cells, being able to demonstrate that stem cells can be definitely safe and successful in a controlled clinical setting is more important than ever.”
Holoclar has been in development since the 1990s, and was granted orphan drug status in 2008. The stem cells that allow the regeneration of the cornea reside in a small area in the eye called the limbus. By harvesting stem cells from this area the epithelium that covers the corneal surface can be reconstructed.
This looks similar to a contact lens and can transplanted into the patient and can lead to a full recovery of visual activity without any rejection reaction, as it consists of cells from the patient themselves.
George Underwood
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