This groundbreaking phase 1/2 trial tested CALEC (Cultivated Autologous Limbal Epithelial Cells), a stem cell treatment for corneal injuries developed at Mass Eye and Ear. The procedure takes stem cells from a patient’s healthy eye, expands them into a graft, and transplants them into the damaged eye.
Results showed impressive 92-93% success rates at 12-18 months, with complete corneal restoration in 77-79% of participants. All patients experienced vision improvements with minimal adverse events.
The treatment addresses limbal stem cell deficiency from chemical burns or trauma, which previously had limited treatment options. While currently experimental and limited to patients with one healthy eye, researchers hope to develop an allogeneic version using donor cells for patients with bilateral damage.
Researchers believe these promising results warrant additional trials toward FDA approval, potentially offering hope to patients with previously untreatable corneal injuries.
