First stem-cell therapy recommended for approval in EU

The European Medicines Agency (EMA) has recommended Holoclar, the first advanced therapy medicinal product (ATMP) containing stem cells, for marketing approval in the European Union (EU).

Holoclar is a Tissue Engineering Product to treat moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eye(s) in adults. It is the first medical treatment recommended for LSCD, a rare eye condition resulting in blindness. Holoclar is a living tissue equivalent intended to be transplanted in the affected eye(s) after removal of the altered corneal epithelium. The applicant for Holoclar is Chiesi Farmaceutici S.p.A. Holoclar was based on the pioneering scientific work of Michele de Luca and Graziella Pellegrini (Centre for Regenerative Medicine, Modena, Italy), both members of the EATRIS academic network.

“Holoclar is the first Tissue Engineering Product (TEP) authorized for marketing in Europe. This is a major step forward indicating the maturity of stem-cell based therapies, which have so far a much sought dream”, Giovanni Migliaccio, scientific director at EATRIS commented.

The CAT and the CHMP recommended a conditional marketing authorization requiring further clinical data for the long-term efficacy. Holoclar is an orphan medicine and an advanced therapy medicinal product (ATMP) and EMA provided protocol assistance to the applicant during the development of the medicine on multiple occasions.

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