Kidswell Bio will soon conduct clinical research using autologous cells for cerebral palsy at Nagoya University regarding the company’s ongoing research on a therapy using deciduous dental pulp stem cells (SHED). In October 2022, Nagoya University and the company jointly applied for a patent for the treatment of cerebral palsy using HED, for which the company has established a master cell bank, and in February 2023, a clinical research plan led by Nagoya University was announced, In February 2023, a clinical research plan led by Nagoya University was approved by the university’s Specified Accredited Committee for Regenerative Medicine. The clinical research to be conducted at Nagoya University will involve a single administration to three patients between the ages of 6 and 12. Since this will be the first administration to humans, safety will be prioritized and autologous cells will be used. The observation period will be one year, and in addition to confirming safety, efficacy will also be confirmed based on evaluation indices. The company believes that the gross motor function scale (GMFM), which is commonly used for cerebral palsy, is unlikely to reflect clinical improvement, so it plans to conduct its own individual motor function evaluation, including gait analysis and standing stability, after discussions with medical institution personnel. In parallel with the clinical research, the company plans to start an exploratory company-led clinical trial (Phase 1/2a) using SHED from other companies as early as FY2025. The company plans to apply for and receive approval in FY2030.
The treatment of cerebral palsy using dental pulp stem cells has been studied in collaboration with Nagoya University using a rat model of chronic cerebral palsy in which the hemisphere of the brain is damaged, and it was confirmed that administration of SHED after the equivalent of 2 years of age in humans (5 weeks in rats) improved motor impairment. The mechanism of action is assumed to be the elongation of nerve axons by growth factors secreted by SHED.
It is estimated that there are 24,100 patients under the age of 18 and 54,000 patients over the age of 18 in Japan with cerebral palsy, while the number of patients overseas is estimated to be about 10 times that number. The cost for a cerebral palsy patient to reach adulthood is estimated to be 25 million yen to 70 million yen more than for a normal person. On the other hand, only about 1,400 patients have been covered by the Obstetric Medical Compensation System (totaling 30 million yen until they reach adulthood), which is a low coverage rate in relation to the total number of patients.
SHED was acquired by Kidwell Bio in October 2019 when it made Cell Technology , which had developed services for pulp cell banks and tooth donations for regenerative medicine, a wholly owned subsidiary of Kidwell Bio, and aims to expand into regenerative medicine products. These are young nerve-derived stem cells obtained from deciduous teeth, which have been shown to have higher proliferative capacity than mesenchymal stem cells (MSCs) from permanent dental pulp, bone marrow MSCs, and adipose MSCs, as well as higher regenerative capacity for the nervous system and bone. In addition to developing the first-generation SHED without genetic modification as a treatment for cerebral palsy and other disorders, the company aims to treat brain tumors and other disorders with a second-generation genetically modified and enhanced SHED.