Autologous Bone Marrow Stromal Cell Transplantation for Stroke: RAINBOW Project

Abstract

In recent years, the clinical application of regenerative medicine using stem cells has been heralded as a new approach to the treatment of cerebral infarction. Our translational researches about bone marrow stromal cells (BMSC) transplantation for stroke was supported by Initiative for Accelerating Regulatory Science in Innovative Drug, Medical Device, and Regenerative Medicine, which is the fund from Ministry of Health, Labour and Welfare in Japan, from 2012. Our on-going clinical trial, Research on Advanced Intervention using Novel Bone marrOW stem cell (RAINBOW) study, is a phase Ⅰ study for acute ischemic stroke and the first subject was enrolled in June 2017. Autologous BMSCs were cultured with human platelet lysate (PL), instead of fetal calf serum (FCS), in the cell processing center. The cells were transplanted around the infarct stereotactically. In advance, the donor cells were labeled with superparamagnetic iron oxide (SPIO) for cell tracking using MRI. After the transplantation, ¹⁸F-fluorodeoxyglucose (FDG) PET and ¹²³I-Iomazenil SPECT were performed for the analysis of cellular function and brain metabolism. We expect that our study will evolve the autologous BMSC transplantation for stroke into the next generation. In the present article, we report our experience from the point of view of mechanisms of actions and therapeutic strategy, nonclinical studies, and subject screening in the clinical trials.