Clinical Research Support Using a License to Manufacture Specified Cell-Processed Products

「In joint research with iPS Portal Co., Ltd. toward a manufacturing and storage service for autologous iPS cells derived from cord blood, the company successfully produced high-quality iPS cells from cord blood that had been cryopreserved by the company for more than 20 years, confirming that stored cord blood is an excellent source. The results were presented at the Japanese Society for Regenerative Medicine conference in March 2026.」

「In clinical research in regenerative medicine, the clinical study of “development of a treatment using autologous cord blood nucleated cells for autism spectrum disorder (ASD)” began with the Department of Developmental Pediatrics at the Osaka Metropolitan University Graduate School of Medicine. The study received more applications than the available slots, and administration to the first patient has already taken place. In September 2025, the company also announced the start, jointly with iPS Portal Co., Ltd., of a study on the manufacturing and storage process and clinical application of autologous iPS cells derived from cord blood.」

「A clinical study of “development of a treatment using autologous cord blood nucleated cells for autism spectrum disorder (ASD)” began with the Department of Developmental Pediatrics at the Osaka Metropolitan University Graduate School of Medicine. ASD is said to be diagnosed in 1 in 100 people, and the study received many applications to participate as soon as recruitment began. The first administration slot has already been filled.」

「In research and development in regenerative medicine using cord blood, the clinical study described above on “development of a treatment using autologous cord blood nucleated cells for autism spectrum disorder” began, and the company issued a press release on 29 October this year. Recruitment of participants is scheduled to begin.」

「The company also decided and announced in June this year that it would begin, with the same group, “development of a treatment using autologous cord blood nucleated cells for autism spectrum disorder,” and is preparing to launch clinical research in 2024.」

「The company also decided and announced in June this year that it would begin, with the same group, “development of a treatment using autologous cord blood nucleated cells for autism spectrum disorder.”」

「In the United States, the number of people whose cord blood is stored by the company participating in the FDA-approved cord blood administration program for children with cerebral palsy and other conditions at Duke University is increasing, and the results have been favorable.」

「In the field of regenerative medicine using cord blood, the Department of Pediatrics at Kochi University Hospital published favorable results in August this year from Japan’s first clinical study, a Phase I trial of autologous cord blood administration for children with cerebral palsy. Clinical research is also progressing on a multicenter Phase II trial of autologous cord blood stem cell administration for children with hypoxic-ischemic encephalopathy (HIE), led by the Department of Developmental Pediatrics at the Osaka Metropolitan University Graduate School of Medicine, with administration to the first patient successfully completed.」

「In Japan, clinical research using cord blood for pediatric neurological disorders is under way at Kochi University Hospital, Osaka Metropolitan University Hospital and other institutions. In the United States, following favorable results from a Phase II clinical study at Duke University, a program to treat cerebral palsy and other conditions with cord blood is being advanced there. Progress has been significant, including the establishment of a pathway for people whose cord blood is stored by StemCell Institute to travel from Japan to the United States for treatment.」

「In clinical trials aimed at putting autologous cord blood treatment into practical use, a group led by Osaka Metropolitan University Medical School is conducting a Phase II trial for hypoxic-ischemic encephalopathy. At Kochi University Hospital, Japan’s first “sibling-to-sibling cord blood administration study” is progressing after receiving approval from the Ministry of Health, Labour and Welfare.」

「At Kochi University Medical School, the Phase I clinical trial of autologous cord blood treatment for brain disorders, including pediatric cerebral palsy, has been completed. As the next step, Japan’s first “sibling-to-sibling cord blood administration study plan” has received approval from the Ministry of Health, Labour and Welfare, and preparations for implementation are under way.」

「In November 2020, a Phase II clinical study for hypoxic-ischemic encephalopathy using cord blood began at Osaka City University Hospital. Both this and the Kochi University study are Japan’s first clinical studies using cord blood, and are expected to make a significant contribution to increasing the perceived value of cord blood storage.」

「Also that month, a clinical study of regenerative medicine planned at Kochi University Medical School, aimed at improving brain disorders through the administration of cord blood stored by the company for siblings, was approved by the Ministry of Health, Labour and Welfare’s Council for Medical Science and Health Technology, Regenerative Medicine Evaluation Committee.」

「In clinical trials aimed at putting autologous cord blood treatment into practical use, preparations are under way at Kochi University Medical School for a Phase II trial of treatment for brain disorders, including pediatric cerebral palsy. A Phase II trial for hypoxic-ischemic encephalopathy has already begun in a group led by Osaka City University Medical School.」

「Clinical trials aimed at putting autologous cord blood treatment into practical use are progressing, including those at Kochi University Medical School and Osaka City University Medical School.」

「A Phase II clinical study by the Osaka City University group for hypoxic-ischemic encephalopathy is also expected to begin shortly.」

「The trial was scheduled to continue through the end of fiscal 2019. After safety has been confirmed and proof of concept established, Human Life Code Co., Ltd. plans to conduct a company-sponsored trial of umbilical cord-derived MSCs as a regenerative medicine product and seek regulatory approval.」

「The Phase I trial at Kochi University Medical School using autologous cord blood for brain disorders, including pediatric cerebral palsy, has progressed steadily under the Act on the Safety of Regenerative Medicine since January last year, and administration to all 6 planned patients has already been completed. A new domestic Phase I clinical study using autologous cord blood for autism spectrum disorder (ASD) is also being planned.」

「Clinical research using autologous cord blood mononuclear cell transfusions for brain disorders, including pediatric cerebral palsy, is currently being conducted at Kochi University Medical School under the Act on the Safety of Regenerative Medicine, and results are anticipated.」

「Since January this year, Kochi University Medical School has been conducting clinical research under the Act on the Safety of Regenerative Medicine on autologous cord blood mononuclear cell transfusions for brain disorders, including pediatric cerebral palsy.」

「In December last year, Kochi University notified the Ministry of Health, Labour and Welfare, under the Act on the Safety of Regenerative Medicine, of a clinical trial of cord blood treatment for children with cerebral palsy. Preparations for implementation are currently under way.」

「In February this year, the company obtained a manufacturing license from the Ministry of Health, Labour and Welfare under the Act. This established a new pathway for applying cord blood to regenerative medicine. Going forward, the company plans to collaborate with universities on joint research and to begin clinical trials in Japan.」

「In February this year, the company’s cell processing center obtained from the Ministry of Health, Labour and Welfare a manufacturing license for specified cell-processing products under the Act on the Safety of Regenerative Medicine. This makes it possible to provide stem cells to medical institutions offering regenerative medicine, facilitating clinical research using cord blood-derived stem cells and supporting further progress in research.」