February 6, 2020
Keio University School of Medicine
Keio University Hospital
Japan Agency for Medical Research and Development (AMED)
On February 5, the Type 1 Regenerative Medicine Provision Plan for the clinical research on the "Safety Study of Allogeneic iPS Cell-Derived Regenerated Cardiomyocyte Spheroid Transplantation for Patients with Refractory Severe Heart Failure," planned by Professor Keiichi Fukuda of the Department of Cardiology, Keio University School of Medicine, was judged by the Keio University Specified Certified Committee for Regenerative Medicine to be in compliance with the provision standards for regenerative medicine stipulated by the Act on the Safety of Regenerative Medicine (Act No. 85 of 2013) and its enforcement regulations (Ordinance of the Ministry of Health, Labour and Welfare No. 110).
Moving forward, Keio University School of Medicine and Keio University Hospital will proceed without delay with the necessary procedures to implement this clinical research aimed at realizing this new treatment method, including submitting this provision plan to the Minister of Health, Labour and Welfare, based on the provisions of the Act on the Safety of Regenerative Medicine and its enforcement regulations.
For the full press release, please see below.