Dr Ula Jurkunas. Credit: Mass. Eye and Ear

The successful trial of a new stem cell cultivation technique to repair corneal trauma has made its US developers the first to meet the FDA’s strict tissue engineering requirements.

Researchers at Massachusetts Eye and Ear conducted a phase 1 trial to assess the safety and feasibility of their cultivated autologous limbal epithelial cell transplantation (CALEC) technique, which involves growing the patient’s healthy limbal stem cells on human amniotic membrane (AmnioGraft) for up to three weeks. Of the trial’s four patients, each with limbal stem cell deficiency (LSCD) from chemical burns to one eye, two had significant vision improvements with no further intervention required, while two went on to have successful corneal transplants after CALEC treatment.

Current options for patients are limited to limbal allografts, which carry a high risk of rejection and require long-term systemic immunosuppression; or autologous limbal transplantation, which risks inducing LSCD to the donor eye, said lead author Dr Ula Jurkunas in Science Advances. “Our early results suggest that CALEC might offer hope to patients who have been left with untreatable vision loss and pain associated with major cornea injuries.”

The next trial involves 15 patients, who will be tracked for 18 months after CALEC treatment.