Chiesi gains a pioneering marketing OK for stem cell therapy

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.

Holoclar, Europe's first stem cell therapy--Courtesy of Chiesi

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.

Chiesi's scientific odyssey in gaining an approval for Europe's first marketed stem cell therapy underscores the huge challenges that remain in the field. The early excitement that helped inspire a state-funded approach to stem cell development in California under the Bush administration has given way to a downturn in the field triggered by the daunting process needed to make regenerative therapies a reality. Major developers have largely steered clear of stem cell development work, put off by the big investments in time and money that will be needed to see products to the market.

The EMA provided its stamp of approval last fall.

"The authorization process has been long and complex, but the result achieved today shows that cells can be cultured according to pharmaceutical standards appropriate to guarantee safety and efficacy," says Professor Michele De Luca, the co-founder of Holostem and a director of the CMR of the University of Modena. "In addition, in a period of great confusion about the real therapeutic possibilities of stem cells, such as the one we are living in, being able to demonstrate that stem cells can be definitely safe and successful in a controlled clinical setting is more important than ever."

- here's the release

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