ex vivo reconstructed autologous human corneal epithelium containing stem cells

Holoclar (ex vivo reconstructed autologous human corneal epithelium containing stem cells) is an autologous advanced therapy medicinal product (ATMP) used for the treatment of moderate to severe limbal stem cell deficiency (LSCD) caused by physical or chemical burns to the eye. Developed by Holostem Terapie Avanzate, it was the first stem cell-based product to receive marketing authorization in the European Union. The treatment process involves taking a small biopsy (1-2 mm²) of healthy limbal tissue from the patient's eye, which is then expanded ex vivo on a fibrin scaffold using cell culture techniques. The resulting circular sheet of corneal epithelium contains limbal stem cells that, when surgically transplanted back onto the damaged cornea, proliferate and differentiate to reconstruct a healthy corneal surface. This restores the transparency and integrity of the corneal epithelium, significantly improving vision and reducing symptoms in patients with LSCD.

Brand names

Holoclar

Other names

ex vivo expanded autologous human corneal epithelial cells containing stem cellsautologous limbal stem cells