In a major milestone for the use of stem cell therapies worldwide, Europe has approved the first medicine containing stem cells to treat limbal stem cell deficiency in patients who have suffered physical or chemical burns to the eyes. After a positive review from the European Medicines Agency's Committee for Medicinal Products for Human Use in December 2014, the approval was expected by many in the medical community, but still marks a large step for stem cell technology.
Italian company Chiesi has been given conditional marketing authorization for their stem cell medicine, known as Holoclar. The product comes in the form of a tiny graft of epithelium taken from an intact area of the patient's own cornea and grown from cell cultures in a lab. The final product is about the size and shape of a contact lens, and is transplanted into the patient's eye, with no risk of rejection because the cells come from the patient's own body.
Without the therapy, limbal stem cell deficiency caused by burns to the eye can eventually cause the victim to go blind, so this therapy represents a significant improvement in the future prospects of patients with this condition. These patients tend to include people who are hurt by hazardous chemicals on the job and those who are assaulted with chemicals in domestic and criminal incidents.
According to representatives for the company, this authorization means that Holoclar will be available "in the near future" to "all European patients who have suffered workplace injuries, domestic accidents or assault with chemical agents".
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