Four-party joint research on a treatment for cerebral palsy using dental pulp stem cells

「Dosing of the final, third pediatric patient was completed in June 2025. In October of the same year, the Independent Safety Evaluation Committee reviewed all 3 cases and concluded that there were "no safety issues through 4 weeks after dosing." In addition, a paper (preprint) summarizing the results of an interim analysis, including an efficacy assessment based on data through 12 weeks after dosing in all 3 cases, was published within the year.」

「As part of this progress, dosing of the final, third pediatric patient was completed in June 2025. In October of the same year, the Independent Safety Evaluation Committee reviewed all 3 cases and concluded that there were "no safety issues through 4 weeks after dosing." In addition, an interim analysis of the study, including an efficacy assessment based on data through 12 weeks after dosing in all 3 cases, is currently underway at the university and is scheduled to be published within the year.」

「The study plans to administer autologous SQ-SHED to 3 patients. Administration has been completed for all patients to date, and observation is under way.」

「Since registration of the first patient in October 2023, enrolment of all patients has progressed smoothly, and SHED administration and subsequent observation are under way.」

「A clinical study led by Nagoya University involving children with cerebral palsy, the first-in-human trial of stem cells from human exfoliated deciduous teeth (SHED), was expected to begin by the end of 2023. In October 2023, registration of the eligible children was completed, and preparations for beginning administration were steadily progressing.」

「A clinical study led by Nagoya University involving children with cerebral palsy, the first-in-human trial of stem cells from human exfoliated deciduous teeth (SHED), was expected to begin by the end of 2023. In October 2023, registration of the eligible children was completed, and preparations for beginning administration were steadily progressing.」

「With respect to the Company's work on cerebral palsy with Nagoya University, the first improvement in motor impairment in a chronic-stage cerebral palsy model worldwide was confirmed following administration of stem cells from human exfoliated deciduous teeth (SHED). Based on this result, a clinical study led by Nagoya University involving children with cerebral palsy, the first-in-human trial of SHED, is expected to begin in 2023, and preparations for beginning administration are currently under way.」

「As the first step toward bringing SHED into clinical development, preparations are currently under way to begin administration in a clinical study of cerebral palsy led by Nagoya University, the first-in-human trial of SHED. The development stage has advanced from exploratory and basic research, which had been conducted since SHED was introduced in 2019, to the clinical stage involving administration to humans.」

「Alongside research and development of SHED, the Company is also advancing the establishment of a patent portfolio with a view to product commercialisation through collaboration with academic institutions. In October 2022, for example, it jointly filed a patent with Nagoya University, a member of the Tokai National Higher Education and Research System, for a treatment for cerebral palsy.」

「For dental pulp stem cells, the Company has had multiple academic institutions and companies assess their potential to provide new treatments in areas such as bone and neurological diseases by determining their suitability for treating diseases. During the previous consolidated fiscal year, the Company entered into joint research agreements with Showa University for bone-related diseases, Gifu Pharmaceutical University for eye-related diseases, and the Tokyo Metropolitan Institute of Medical Science, Nagoya University Hospital and Tokyo Medical and Dental University for cerebral palsy, as well as with Oita University for peripheral nerve paralysis and Nagoya University for spinal cord injuries. It also entered into a joint research and development agreement with ORTHOREBIRTH Co., Ltd. to create a treatment for cleft lip and palate, and a joint commercialisation agreement with Mochida Pharmaceutical Co.,Ltd. for regenerative medicine products for rare and intractable gastrointestinal diseases, including intestinal neuronal dysplasia. Research and development activities are being advanced under each agreement.」

「During the current consolidated fiscal year, the Company entered into separate joint research agreements with Showa University for bone-related diseases, Gifu Pharmaceutical University for eye-related diseases, the Tokyo Metropolitan Institute of Medical Science, Nagoya University Hospital and Tokyo Medical and Dental University for cerebral palsy, Oita University for peripheral nerve paralysis, and Nagoya University for spinal cord injuries.」

「In January 2020, the Company entered into separate four-party joint research agreements with the Tokyo Metropolitan Institute of Medical Science, Nagoya University and Tokyo Medical and Dental University to create a treatment for cerebral palsy using dental pulp stem cells.」