The world’s first clinical trial using iPS cell sheets for corneal epithelial stem cell deficiency

Background: The world’s first clinical trial using induced pluripotent stem cell sheets for corneal epithelial stem cell deficiency is underway. Elsewhere, we have analysed the protocol and argued it basically ethical. Main points for debates: We raise three ethical points. First, the new therapy should demonstrate greater therapeutic effects when compared with other treatment methods. Second, cost is a potential barrier to widespread adoption. Third, the shortage of eye donors in Japan raises ethical concerns of fairness, as Japan relies on donors in other countries Conclusion: While there are many issues to be debated and addressed for this new eye therapy, we believe the ophthalmology field will assume moral leadership in the pursuit of iPSC clinical research. Background On December 26, 2018, the review committee of Osaka University, Japan, granted conditional approval for a clinical trial to transplant corneal cell sheets from induced pluripotent stem cells (iPSC) in patients with corneal epithelial stem cell deficiency [1]. We previously objected to the protocol in a separate iPSC transplantation study for heart failure patients as ethically impermissible [2]. However, the protocol in the latest corneal trials appears to meet ethical standards very well. It appears to be fully reliable in its handling of adverse events (rejection or tumorigenicity), as transplanted corneal sheets can be easily removed. Since the new study is already underway, an ethical discussion is even more critical. Main points for debates Below, we raise three points for debate for this up and coming therapy. First, the potential benefits of the study seem to warrant the risk to which research subjects are exposed. The question of whether iPSC sheet grafts can truly surpass allogeneic donated eye transplants or amniotic membranes in quality and therapeutic effects warrants rigorous scientific assessment. The subjects in this transplant study are patients with corneal epithelial stem cell deficiency. Some ophthalmology specialists note that in other cornea diseases, endothelial dysfunction is particularly salient. iPSC sheets replace mainly the epithelium. On the other hand, amniotic membrane demonstrates a record of effectiveness within certain parameters. Demonstrating greater therapeutic effects will be key to adding another future option to cornea transplant methods. *Correspondence to: Akira Akabayashi, Department of Biomedical Ethics, School of Public Health, University of Tokyo Graduate School of Medicine, Tokyo, Japan, E-Mail: akirasan-tky@umin.ac.jp