September 6, 2022
Keio University School of Medicine
Keio University Hospital
Project Professor Shigeto Shimmura, Project Lecturer Emi Inagaki, and their colleagues from the Department of Ophthalmology, Keio University School of Medicine, have submitted a "Plan for the Provision of Class I Regenerative Medicine" for an "Exploratory study of human adipose-derived mesenchymal stem cells (ADSCs) for idiopathic peripheral ulcerative keratitis and corneal ulcers associated with cGVHD" to the Minister of Health, Labour and Welfare. This submission was made in accordance with the provisions of the Act on the Safety of Regenerative Medicine and its enforcement regulations. As a result, on June 24, 2022, the Health Sciences Council (Regenerative Medicine Evaluation Division) confirmed that this plan conforms to the standards for providing regenerative medicine. This plan has been reviewed by Keio University's Special Certified Committee for Regenerative Medicine. The ADSCs used in this study are specified cell products manufactured by Rohto Pharmaceutical Co., Ltd., which holds a license for manufacturing specified cell products. This product will be prepared and administered at the cell processing facility within Keio University Hospital on the day of surgery.
Please see below for the full press release.