Cellusion Inc. (CEO: Shin Hatou, M.D. Ph.D.) is thrilled to announce 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) the successful transplant of our iPS cell-derived corneal endothelial cell substitute (“CLS001”) to the first patient in the world (First In Human*, “FIH Study”)!
The Department of Ophthalmology at Keio University Hospital recently conducted a groundbreaking exploratory clinical study, jRCTa031210199, to evaluate the safety and efficacy of CLS001, an iPS Cell-Derived Corneal Endothelial Cell Substitute, in patients with regrafted cases of bullous keratopathy. This is a remarkable venture that could potentially revolutionize the treatment of this vision-threatening condition.
At the review of the Independent Data Monitoring Committee held in January 2023, Prof. Shimmura joyfully reported that the safety of CLS001 transplantation was confirmed, as no adverse events had been observed in the past three months. Moreover, he shared that the visual acuity, central corneal thickness, and minimal corneal thickness had been improving since the transplantation.
Cellusion is tackling the global cornea shortage head-on with its innovative solution, CLS001. As the FIH study moves forward, Cellusion is gearing up to launch its sponsored clinical trial, in an effort to make a real difference in the lives of those affected by the shortage.
First-in-human (FIH) studies are a critical part of drug development, as they are the first time a drug is tested on humans. These studies involve careful safety and efficacy testing in animal studies before the drug is administered to humans. FIH studies provide invaluable insights into the safety and efficacy of drugs, and are an essential part of the drug development process.
About Bullous Keratopathy
Bullous keratopathy is a progressive eye disease that causes blistering of the cornea and visual impairment due to clouding caused by a decrease in corneal endothelial cells. If left untreated, it can lead to blindness.
Currently, the only available treatment for this condition is a corneal transplant, which involves replacing the damaged cells with healthy ones from a donor. Unfortunately, with over 10,000 patients in Japan and more than 13 million people worldwide on the waiting list for corneal transplants, the demand for donors far outweighs the supply.
In spite of the millions of waiting patients suffering from blinding diseases such as Bullous Keratopathy, only 180,000 corneal transplants are performed worldwide each year, creating an immense supply-demand gap.
This is largely due to the need for donor corneas, skilled corneal transplant ophthalmologists, and Eye Banks to successfully perform such treatments. This issue calls for a greater effort to bridge the gap and ensure that everyone who needs a corneal transplant can get one.
Cellusion is revolutionizing the way we treat Bullous Keratopathy, a condition that affects more than half of all corneal transplant patients. With their innovative CLS001 CECSi cell technology, they are providing a safe and simple injection procedure to regenerate the corneal endothelium, replacing the current supply limitations with iPS cells that have excellent proliferative properties. Get ready to experience corneal transplantation like never before!
Cellusion is a revolutionary regenerative medicine startup, born from the Department of Ophthalmology, Keio University School of Medicine in 2015. Our mission is to revolutionize healthcare and improve the quality of life around the world with our cutting-edge cell therapy technologies, including a unique differentiation induction method from iPS cells to CECSi endothelial cells. Through this groundbreaking cellular technology breakthrough, we bring a clear vision of the future to the global community.