June 8, 2021
Keio University School of Medicine
Keio University Hospital
The Type 1 Regenerative Medicine Provision Plan for the "Exploratory Clinical Study to Evaluate the Safety and Efficacy of Transplantation of iPS Cell-Derived Corneal Endothelial Cell Substitutes for Bullous Keratopathy," a research project led by Associate Professor Shigeto Shimmura of the Department of Ophthalmology, Keio University School of Medicine, was approved on May 12 by Keio University's Specified Certified Committee for Regenerative Medicine. The committee determined that the plan complies with the standards for providing regenerative medicine as stipulated by the Act on the Safety of Regenerative Medicine and its enforcement regulations.
Moving forward, the Keio University School of Medicine and Keio University Hospital will proceed without delay with the necessary procedures to conduct clinical trials aimed at realizing this new treatment method. These procedures, including the submission of this provision plan to the Minister of Health, Labour and Welfare, will be carried out in accordance with the provisions of the Act on the Safety of Regenerative Medicine and its enforcement regulations.
Please see below for the full press release.