Review Article on Advances in Corneal Regenerative Medicine with iPS Cells Published in Japanese Journal of Ophthalmology


Cellusion Inc. (CEO: Shin Hatou, M.D. Ph.D., “Cellusion”), a deep tech start-up developing iPS cell-derived corneal endothelial cell substitute for the treatment of bullous keratopathy, announced that Shin Hatou, CEO of Cellusion and our collaborater Shigeto Shimmura, Professor in the Department of Ophthalmology, Keio University School of Medicine, published a review article on Advances in Corneal Regenerative Medicine with iPS Cells in the Japanese Journal of Ophthalmology issued by the Japanese Ophthalmological Society.

“The cornea is a pioneering area of regenerative medicine, and Japanese researchers have led the world in this field. In Japan, 3 different epithelial sheet regenerative medicine products have been approved for corneal epithelial stem cell deficiency, and the first-in-human studies of cultured corneal endothelial cell suspension transplants, induced pluripotent stem cell (iPS cell)-derived corneal epithelial sheet transplants, and iPS cell-derived corneal endothelial substitute cell transplants were all conducted and reported globally for the first time by Japanese researchers. ”

A joint research group between Cellusion and the Department of Ophthalmology at Keio University School of Medicine has also developed iPS cell-derived corneal endothelial cell substitute (CLS001), and is conducting the world’s first clinical study using these cells to treat bullous keratopathy.
This review describes the progress and challenges of corneal epithelial and endothelial regenerative medicine and the promising future of corneal regenerative medicine with iPS cells.

Information on the publication of this research is as follows:
Hatou S, Shimmura S. Advances in corneal regenerative medicine with iPS cells. Jpn J Ophthalmol. 2023 Aug 14. doi: 10.1007/s10384-023-01015-5.
Advances in corneal regenerative medicine with iPS cells

[About CLS001]
CLS001 is alternative cell to corneal endothelial cells produced by efficiently differentiating iPS cells, which can be differentiated into various types of cells, based on Cellusion’s proprietary technique. Cellusion is promoting the development of CLS001 as a therapeutic regenerative medicine product for bullous keratopathy, which accounts for more than half of the corneal transplant cases, by combining “CECSi Cells* made from iPS cells with excellent proliferative properties” and “a simple injection cell delivery procedure without needs of human expertise.” Cellusion is also advancing preparations for company-sponsored clinical trials in Japan, as well as preparations for global clinical trials.
*CECSi Cells: Corneal Endothelial Cell Substitute from iPS Cells

[About Bullous Keratopathy]
Bullous keratopathy is a rare disease that occurs when corneal endothelial cells, which control the amount of fluid at the inner-most part of the cornea, decrease due to eye surgery of cataract or genetic factors, resulting in problems with their function, whereby the cornea becomes swollen and causes visual impairment due to opacity. This disease is progressive and may lead to blindness if left untreated. Today, this disease can only be treated by transplanting normally functioning corneal endothelial cells via corneal transplant. Nevertheless, as with other organ transplants, corneal transplants are also facing a serious problem of donor shortage. In Japan alone, it is estimated that there are about 10,000 patients, and in the global survey conducted in 2013 it was reported that approximately 13 million patients are waiting for corneal transplants.

[About Cellusion]
Cellusion is a regenerative medicine start-up originating from the Department of Ophthalmology, Keio University School of Medicine, with “Regenerating Human Potential” as its mission and “More Freedom and More Smiles to the World” as its vision. Based on patented technology such as its proprietary technique of efficiently producing corneal endothelial substitute cell from iPS cells, Cellusion is promoting R&D aimed at meeting medical needs from the perspective of “patient centricity” by leveraging cutting-edge regenerative medicine technology, including the lead program CLS001 that aims to meet the global corneal transplant demands.

Company: Cellusion Inc.
CEO: Shin Hatou, M.D., Ph.D.
Headquarters: 8-6 Nihonbashi-Kobuna, Chuo, Tokyo 103-0024, JAPAN
Founded: January 2015

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