① Basic Study on Spinal Cord Functional Regeneration Using Genetically Engineered Neural Stem Cells Derived from Human iPS Cells

This AMED-funded project, led by Keio University’s Research Center for Regenerative Medicine (KRM) in collaboration with the National Institute of Health Sciences, aims to restore function in patients with chronic-stage spinal cord injuries—a condition that has long posed significant therapeutic challenges. By employing innovative approaches such as the exploration of marker genes, the project seeks to enable cell transplantation and expedite its clinical application.

※On March 21, 2025, the research team led by Professor Hideyuki Okano, Director of the KRM, and Professor Masaya Nakamura, Chairperson of CReM TONOHANE Steering Committee, announced the world’s first safety results of an iPS cell-based therapy for severe spinal cord injury. Moving forward, the team plans to verify therapeutic efficacy and accumulate further evidence to support clinical application.
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② Bone and Cartilage Regenerative Therapy for Idiopathic Osteonecrosis of the Knee Joint Using Bio 3D Printing Technology

Cyfuse Biomedical K.K.,Keio University Hospital and Fujita Health University are collaborating to develop a groundbreaking therapy that simultaneously regenerates both bone and cartilage for patients whose damage has progressed to the bone due to conditions such as knee osteoarthritis, and who therefore require bone or cartilage regeneration. Looking ahead, the research team intends to move swiftly toward clinical trials and other clinical studies, aiming to deliver this therapy to patients as quickly as possible.

③ Large-Scale Expansion of Human Mesenchymal Stem Cells (hMSC) Based on Quality by Design (QbD)

Cyto-Facto Inc. and Fujita Health University are conducting a feasibility study on large-scale expansion of human mesenchymal stem cells (hMSCs), while systematically varying culture conditions. The diverse data and practical insights gained throughout the expansion process will be accumulated at CReM TONOHANE, with the ultimate goal of disseminating high-quality raw materials cells and realizing stable large-scale production of the final product.

④ Development of a Human Adipose-Derived Mesenchymal Stem Cell Therapy for Idiopathic Peripheral Ulcerative Keratitis and Corneal Ulcers Associated with Chronic Graft-versus-Host Disease (cGVHD)

Fujita Health University, ROHTO Pharmaceutical Co., Ltd., and Keio University Hospital are collaborating to validate the safety of subconjunctival injections of human adipose-derived mesenchymal stem cells for idiopathic peripheral ulcerative keratitis and corneal ulcers associated with chronic graft-versus-host disease (cGVHD) that do not respond to conventional conservative treatments. This study also aims to verify the efficacy of this approach, which is expected to be less invasive for patients.

⑤ The Cost-Effectiveness Analysis of Regenerative Medical Products from The Perspective of HTA（Health Technology Assessment）

Kanagawa University of Human Services and Keio University are collaborating to develop an economic evaluation model aimed at estimating the costs of currently opaque cell culture, manufacturing, and production processes, as well as projecting the potential economic impact on regenerative medical products when they are implemented in society.