The European Commission has waved through the continent's first stem
cell therapy, providing conditional marketing approval for what is
essentially a new lens that can be fashioned out of a patient's own
cells and used to restore sight in people whose eyes have been severely
damaged.
Italy's Chiesi
now can begin the process of selling the treatment, dubbed Holoclar, 7
long years after gaining an orphan drug designation and more than 15
years after establishing a proof of concept for the treatment method.
Holoclar will be made by a company called Holostem, a spinout from the
University of Modena which Chiesi backed to develop a qualified
manufacturing operation that could win over regulators to the complex
technology.
Thousands of people in Europe may benefit from this treatment, which
will be closely monitored by health officials under the conditional OK
that was granted.
Eyes damaged by burns or chemicals can lose their ability to regenerate
the corneal surface of the eye, a process that naturally occurs in
undamaged eyes every few months. With Holoclar, physicians can harvest
some of the remaining cells required for this regeneration and construct
a patch that can be used to repair the damage. And because these are
autologous cells (from the patient), Chiesi can do this without spurring
a rejection.
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