Accelerating Cell Therapy for Stroke in Japan: Regulatory Framework and Guidelines on Development of Cell-Based Products

Affiliations

• ¹ From the Department of Neurosurgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan (K.H., H.S.); Division of Clinical Research Administration, Hokkaido University Hospital, Sapporo, Japan (H.S.); Department of Neurology, Okayama University Medical School, Japan (K.A., T. Yamashita); Hokkaido University Hospital Clinical Research and Medical Innovation Center, Sapporo, Japan (T.A., N.S.); Department of Stem Cell Biology and Histology, Tohoku University Graduate School of Medicine, Sendai, Japan (M.D.); Department of Neural Regenerative Medicine, Research Institute for Frontier Medicine, Sapporo Medical University School of Medicine, Japan (O.H., M.S.); Department of Neurosurgery, Nagasaki University Hospital, Japan (N.H., I.N.); Department of Neurology and Stroke Center, Tokyo General Hospital, Japan (Y.K.); Department of Neurological Science, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan (Y.K., S.S.); Department of Diagnostic and Interventional Radiology, Hokkaido University Hospital, Sapporo, Japan (K.K.); Department of Neurosurgery, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Japan (S.K.); Institute for Advanced Medical Sciences, Hyogo College of Medicine, Nishinomiya, Japan (T.M.); Neurorehabilitation Research Institute, Morinomiya Hospital, Osaka, Japan (I.M.); Department of Neurosurgery, Kokura Memorial Hospital, Kitakyushu, Japan (I.N.); Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan (K.N., T.T.); Office of Cellular and Tissue-Based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan (K. Sakushima, K. Sawanobori); Department of Regenerative Medicine Research, Institute of Biomedical Research and Innovation, Kobe, Japan (A.T.); Center for Advancing Clinical and Translational Sciences, National Cerebral and Cardiovascular Center, Suita, Japan (H.Y.); Department of Neurosurgery, Osaka University Graduate School of Medicine, Suita, Japan (T. Yoshimine); and Center for Information and Neural Networks, Osaka University, Suita, Japan (T. Yoshimine).
• ² From the Department of Neurosurgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan (K.H., H.S.); Division of Clinical Research Administration, Hokkaido University Hospital, Sapporo, Japan (H.S.); Department of Neurology, Okayama University Medical School, Japan (K.A., T. Yamashita); Hokkaido University Hospital Clinical Research and Medical Innovation Center, Sapporo, Japan (T.A., N.S.); Department of Stem Cell Biology and Histology, Tohoku University Graduate School of Medicine, Sendai, Japan (M.D.); Department of Neural Regenerative Medicine, Research Institute for Frontier Medicine, Sapporo Medical University School of Medicine, Japan (O.H., M.S.); Department of Neurosurgery, Nagasaki University Hospital, Japan (N.H., I.N.); Department of Neurology and Stroke Center, Tokyo General Hospital, Japan (Y.K.); Department of Neurological Science, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan (Y.K., S.S.); Department of Diagnostic and Interventional Radiology, Hokkaido University Hospital, Sapporo, Japan (K.K.); Department of Neurosurgery, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Japan (S.K.); Institute for Advanced Medical Sciences, Hyogo College of Medicine, Nishinomiya, Japan (T.M.); Neurorehabilitation Research Institute, Morinomiya Hospital, Osaka, Japan (I.M.); Department of Neurosurgery, Kokura Memorial Hospital, Kitakyushu, Japan (I.N.); Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan (K.N., T.T.); Office of Cellular and Tissue-Based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan (K. Sakushima, K. Sawanobori); Department of Regenerative Medicine Research, Institute of Biomedical Research and Innovation, Kobe, Japan (A.T.); Center for Advancing Clinical and Translational Sciences, National Cerebral and Cardiovascular Center, Suita, Japan (H.Y.); Department of Neurosurgery, Osaka University Graduate School of Medicine, Suita, Japan (T. Yoshimine); and Center for Information and Neural Networks, Osaka University, Suita, Japan (T. Yoshimine). hshichi@med.hokudai.ac.jp.