Clinical Study Administering SHED for Hypoganglionosis Adopted by AMED
S-Quatre, a Kids Well Bio group company, announced that a joint clinical research project with Kyushu University using SHED stem cells to treat hypoganglionosis has been adopted by AMED.
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- 📰 Published: April 6, 2026 at 18:05
- 🔍 Collected: April 6, 2026 at 09:30
- 🤖 AI Analyzed: April 21, 2026 at 04:25 (354h 55m after Collected)
S-Quatre Inc., a group company of Kids Well Bio, is engaged in research and development utilizing SHED (Stem cells from Human Exfoliated Deciduous teeth) with the aim of creating novel cell therapy drugs (regenerative medicine products) for pediatric and rare diseases that currently lack effective treatments.
We are pleased to announce that a joint research proposal with Kyushu University, titled "Development of a novel treatment for hypoganglionosis using human SHED," has been adopted by the Japan Agency for Medical Research and Development (AMED) for the "FY2026 Comprehensive Research Project for Overcoming Pediatric Diseases" (*1). The principal investigator for this project is Dr. Koichiro Yoshimaru, Assistant Professor at the Department of Pediatric Surgery, Kyushu University Hospital, and S-Quatre will participate as a co-investigator.
In this study, autologous SHED will be administered to patients with hypoganglionosis (*2) to evaluate its safety and efficacy. SHED secretes an abundance of growth factors and cytokines that are expected to promote nerve growth, making it a promising new therapeutic approach for this disease. Furthermore, a clinical study administering SHED for this condition is an unprecedented, world-first endeavor.
Within this study, S-Quatre will be responsible for the manufacturing and quality control of SHED, providing expertise accumulated through past cell manufacturing and clinical development.
Through this research, our corporate group aims to open up new therapeutic possibilities for this disease, which has had limited effective treatments until now. We will continue to drive research and development forward to deliver meaningful options to patients and their families as quickly as possible.
*1: Regarding the adoption of 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 caused by a congenital shortage of ganglion cells in the intestinal tract, significantly impairing intestinal peristalsis and resulting in severe intestinal obstruction symptoms. To date, there is no established effective treatment.
Reference: Intractable Disease Information Center https://www.nanbyou.or.jp/entry/3949
We are pleased to announce that a joint research proposal with Kyushu University, titled "Development of a novel treatment for hypoganglionosis using human SHED," has been adopted by the Japan Agency for Medical Research and Development (AMED) for the "FY2026 Comprehensive Research Project for Overcoming Pediatric Diseases" (*1). The principal investigator for this project is Dr. Koichiro Yoshimaru, Assistant Professor at the Department of Pediatric Surgery, Kyushu University Hospital, and S-Quatre will participate as a co-investigator.
In this study, autologous SHED will be administered to patients with hypoganglionosis (*2) to evaluate its safety and efficacy. SHED secretes an abundance of growth factors and cytokines that are expected to promote nerve growth, making it a promising new therapeutic approach for this disease. Furthermore, a clinical study administering SHED for this condition is an unprecedented, world-first endeavor.
Within this study, S-Quatre will be responsible for the manufacturing and quality control of SHED, providing expertise accumulated through past cell manufacturing and clinical development.
Through this research, our corporate group aims to open up new therapeutic possibilities for this disease, which has had limited effective treatments until now. We will continue to drive research and development forward to deliver meaningful options to patients and their families as quickly as possible.
*1: Regarding the adoption of 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 caused by a congenital shortage of ganglion cells in the intestinal tract, significantly impairing intestinal peristalsis and resulting in severe intestinal obstruction symptoms. To date, there is no established effective treatment.
Reference: Intractable Disease Information Center https://www.nanbyou.or.jp/entry/3949