| Modena, Italy / Brno, Czech Republic, May 12, 2021 – Holoclar®, the first stem cell-based medicinal product approved and formally registered in the Western world in 2015, is now available also in Czech Republic.
Holoclar®, manufactured and distributed by Holostem Terapie Avanzate, is a type of advanced therapy medicinal product called “tissue engineered product” and has been designated by the European Medicines Agency (EMA) as an orphan medicine. The therapy is approved in Europe (EU) for adults with moderate to severe limbal stem cell deficiency (LSCD) caused by physical or chemical burns to the eyes. LSCD is a rare condition that can lead to blindness, and it is estimated to affect about 3.3 out of 100,000 people in EU.
“Today is an important milestone for the patients of the eye clinic of the University Hospital of Brno, who will be able to benefit from this innovative therapy – announces Marco Dieci, CEO of Holostem. – And it is also an important achievement for our company, which is opening up to a new country with a view to increasingly international distribution”.
More than thirty years of excellence in research – conducted by a team of internationally renowned scientists in the field of epithelial stem cell biology aimed at clinical translation like professors Graziella Pellegrini e Michele De Luca, and with articles published in the world’s leading scientific journals – have resulted in an advanced therapy that can revolutionize the lives of people affected by severe limbal stem cell deficiency (LSCD). In a nutshell, Holoclar® consists of cells taken from a small undamaged area of the patient’s limbus (at the border between the cornea and the conjunctiva) and then grown ex vivo in the Holostem’s GMP (Good Manufacturing Practice) facility. Here biotechnologists are able to reconstruct in laboratory the epithelium that covers the corneal surface, thanks to the stem cells harvested through a 1-2 mm2 biopsy.
“This graft of epithelium – Holoclar®, precisely – that looks like a kind of contact lens, is then transplanted into the patient and allows to obtain a long-term transparent cornea and a full recovery of visual acuity, without causing any rejection reaction, because it consists of cells of the patient him/herself”, explains prof. Eva Vlková of the University Hospital in Brno.
Holostem is operating in Czech Republic supported by Medasol s.r.o., a company part of Bluedil International, which provides market access and commercial services. Medasol, with twenty years of experience in the commercialization of orphan drugs, supports pharmaceutical and biotech companies in making innovative treatments as Holoclar available to patients affected by rare and severe diseases.
About University Hospital Brno
The Eye Clinic of the University Hospital Brno was established in 1990 as an independent department within the premises of the University Hospital Brno Bohunice. It provides comprehensive care for patients with eye diseases, both diagnostically and therapeutically. Using state-of-the-art equipment, it deals with diseases of the anterior and posterior segment of the eye. It specializes in eye microsurgery, especially surgery of the anterior segment of the eye, including corneal transplantation, retinal diseases, including vitreoretinal surgery, ocular traumatology and strabismus surgery. At present, it provides basic diagnostic, therapeutic and consultative care not only for the South Moravian Region, but also for neighbor regions. |
