Clinical Study Using Stem Cells from Human Exfoliated Deciduous Teeth for Hypoganglionosis Selected by AMED

Our group company, S-Quatre Co., Ltd., is engaged in research and development utilizing Stem cells from Human Exfoliated Deciduous teeth (SHED) with the goal of creating novel cell therapy products (regenerative medicine products) for pediatric and rare diseases that currently lack effective treatments.

Recently, the research project "Development of a Novel Treatment for Hypoganglionosis Using Human Exfoliated Deciduous Tooth-Derived Stem Cells," which we applied for in collaboration with Kyushu University, was selected for the Japan Agency for Medical Research and Development (AMED) "FY2026 Comprehensive Research Project for Overcoming Pediatric Diseases" (*1). The principal investigator for this project is Lecturer Koichiro Yoshimaru of the Department of Pediatric Surgery at Kyushu University Hospital, and S-Quatre is participating as a research collaborator.

In this study, we will administer autologous SHED to patients with hypoganglionosis (*2) to examine its safety and efficacy. Because SHED secretes an abundance of growth factors and cytokines expected to promote nerve growth, it holds potential as a new therapeutic approach for this disease. This will be the first clinical study in history to administer SHED for this condition.

In this research, S-Quatre will be responsible for the manufacturing and quality control of SHED, while also providing the expertise we have accumulated regarding cell manufacturing and clinical development.

Through this research, our group will continue to promote R&D to open up new treatment possibilities for this disease, for which effective treatments have been limited, and to deliver meaningful options to patients and their families as quickly as possible.

*1: Regarding the selected projects for the FY2026 "Comprehensive Research Project for Overcoming Pediatric Diseases": https://www.amed.go.jp/koubo/03005/02/C_00004.html

*2: Hypoganglionosis (Designated Intractable Disease 101) is an intractable disease in which a congenital deficiency of ganglion cells in the intestinal tract significantly impairs peristalsis, leading to severe intestinal obstruction symptoms. To date, there is no established effective treatment. Reference: Intractable Diseases Information Center https://www.nanbyou.or.jp/entry/3949