June 11, 2020
Keio University School of Medicine
Keio University Hospital
Associate Professor Hideaki Ohara, Senior Assistant Professor Kentaro Matsubara, and their colleagues at the Department of Surgery (General and Gastroenterological), Keio University School of Medicine, received a decision on January 24, 2020, from Keio University's Specified Certified Committee for Regenerative Medicine. The decision confirmed that the Class I regenerative medicine provision plan for the "Exploratory Clinical Trial of Adipose-derived Stem/Stromal Cell-derived Platelet-like Cells (ASCL-PLC) for Refractory Skin Ulcers" complies with the standards for providing regenerative medicine as stipulated by the Act on the Safety of Regenerative Medicine (Act No. 85 of 2013) and its Ordinance for Enforcement (Ordinance of the Ministry of Health, Labour and Welfare No. 110).
ASCL-PLC is a seed technology originating from Keio University, produced from mesenchymal stem cells found in subcutaneous adipose tissue. It is a product developed with support from the AMED Bridge Program (Seeds B), with Project Associate Professor Yumiko Matsubara of the Clinical and Translational Research Center as the Principal Investigator and Project Assistant Professor Yukako Uruga and others as Co-Investigators. To conduct the clinical research, Keio University School of Medicine and Keio University Hospital submitted this provision plan to the Minister of Health, Labour and Welfare on April 16, 2020, in accordance with the provisions of the Act on the Safety of Regenerative Medicine and its Ordinance for Enforcement. On June 11, 2020, the Health Sciences Council approved the plan, confirming its compliance with the standards for providing Class I regenerative medicine.
For the full press release, please see below.