On November 7, 2024, researchers from Osaka University published a research paper titled: Induced pluripotent stem-cell-derived corneal epithelium for transplant surgery: a single-arm, open-label, first-in-human interventional study in Japan in the international top medical journal The Lancet.

This clinical study is the first in the world to use corneal epithelial cell sheets (iCEPS) derived from human induced pluripotent stem cells (iPSCs) to repair the cornea of patients with limbal stem cell deficiency (LSCD) visual impairment. The results showed that this new regenerative therapy is safe and helped improve patients' vision. The research team plans to conduct larger clinical trials to better understand the therapeutic effects of the therapy.

In this study, ophthalmologist Kohji Nishida from Osaka University and his team used induced pluripotent stem cells (iPSCs) to treat limbal stem cell deficiency (LSCD). The research team extracted blood cells from a healthy donor, then reprogrammed them into iPSCs, which were then transdifferentiated into a thin, transparent, oval corneal epithelial cell sheet.

For this study, the research team recruited 2 male and 2 female patients with bilateral LSCD, aged between 39 and 72 years old. The research team first removed the scar tissue layer covering the cornea of one eye of the patient, then sutured the human iPSC-derived corneal epithelial cell sheet (iCEPS) and wore a soft protective contact lens.

At week 52, the secondary indicators of the clinical trial showed that the disease stage of all treated eyes improved, corrected distance vision improved, and corneal opacity decreased. One patient experienced a slight regression in vision improvement during the 1-year monitoring period, and the vision improvement of the remaining 3 patients was sustained.

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