Cellusion Inc. (CEO: Shin Hatou, M.D. Ph.D., "Cellusion") announced that our research collaborator, Dr. Shigeto Shimmura, Professor of Fujita Health University and Keio University presented at the 22nd Japanese Society for Regenerative Medicine Annual Conference (Kyoto, Japan, March 23-25, 2023) that iPS cell-derived corneal endothelial cell substitute ("CLS001") was transplanted to the first patient (First In Human*, "FIH Study").

“CECSi Cells made from iPS cells with excellent proliferative properties”

The details of presentation information are as follows;

Title: iPS-derived Cornea Endothelial Substitutes for Corneal Regeneration
Lecture Number: SY-02-2
Date & Time: Thursday, March 23, 2023, 8:30-10:30 a.m.

This FIH study (Study title: Exploratory Clinical Study to Examine Safety and Efficacy of iPS Cell-Derived Corneal Endothelial Cell Substitutes for Bullous Keratopathy, jRCT study protocol number: jRCTa031210199) was conducted at the Department of Ophthalmology, Keio University Hospital to evaluate the safety and efficacy of CLS001 transplantation in patients with regrafted cases of bullous keratopathy.

In the presentation, Prof. Shimmura reported that the safety was confirmed since no adverse event has been observed for 3 months after the CLS001 transplantation at the review of the Independent Data Monitoring Committee held in January 2023. In addition, in terms of the efficacy, he also reported that the visual acuity, central corneal thickness, and minimal corneal thickness has tended to be improved so far.

Cellusion is challenging to solve the global cornea shortage issue by developing CLS001. With the progress of the FIH study, we will accelerate the preparation of the Cellusion sponsored clinical trial.

*First-in-human (FIH) studies: Clinical studies or Phase I clinical trials in which a drug is administered to humans for the first time after its safety and efficacy have been confirmed in animal studies.