A clear cornea is essential to visual acuity and depends on stromal avascularity and epithelial integrity. Corneal renewal and repair are mediated by stem cells of the limbus, the narrow zone between the cornea and the bulbar conjunctiva.
Ocular burns may destroy the limbus, causing limbal stem cell deficiency. In such cases, the cornea acquires an epithelium through the invasion of bulbar conjunctival cells.
This process leads to neovascularization, chronic inflammation and stromal scarring, with corneal opacity and loss of vision.
In this clinical setting, allogeneic corneal transplantation (keratoplasty) is unsuccessful.
Holoclar® is a product of tissue engineering for advanced therapies consisting of an ex vivo reconstructed autologous human corneal epithelium containing stem cells, indicated for the reconstruction of the corneal surface in patients with limbal stem cell deficiency due to ocular burns. The active substance of Holoclar® is represented by the epithelial stem cells contained therein, that engraft and permanently regenerate a functional corneal epithelium allowing recovery of visual acuity.
Holoclar®’s Marketing Authorization holder is Chiesi Farmaceutici S.p.A.