Current status of development for regenerative cell therapy, SB623

SanBio Co., Ltd. is developing regenerative medicine, SB623. SB623 secretes neurotrophic and growth factors, and can possibly show benefit in repair of the damaged brain after stroke. An open-label, single-arm phase I/IIa clinical study was conducted with 18 chronic ischemic stroke patients in the United States to evaluate the safety and clinical outcomes of surgical transplantation of SB623. Clinical evaluation for a one year follow-up period showed significant improvements with all mean scores on the European Stroke Scale, the National Institute of Health Stroke Scale, and on the basis of fugl-Meyer Assessment. All patients experienced neither side effects nor serious treatment-emergent adverse events related to cell treatments. These results suggest that SB623 cell transplantation is safe and effective for treating chronic ischemic stroke. Currently we are conducting clinical studies in Japan and the US, and are accelerating clinical development to provide our cells to patients under new regulation of regenerative medical product in Japan.