Cellusion Announces First Patient Transplanted iPSC-Derived Corneal Endothelial Cell Substitute (CLS001)

An iPS cell-derived corneal endothelial cell substitute (CLS001) was transplanted to the first patient, according to Cellusion.

Research collaborator, Shigeto Shimmura, MD, PhD, Professor of Fujita Health University and Keio University in Japan, provided details of the procedure at the 22nd Japanese Society for Regenerative Medicine Annual Conference (Kyoto, Japan, March 23-25, 2023).

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 reported that the visual acuity, central corneal thickness, and minimal corneal thickness has tended to be improved so far.

With the progress of the FIH study, Cellusion said it will accelerate the preparation of the 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.