World's First Prospective Intervention Study on ALS (Amyotrophic Lateral Sclerosis) Using U-Factor® Fluid Presented at Academic Conference

U-Factor Holdings Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo; Representative Director: Hidehiro Ijima) announced that Dr. Yasuhiro Seta, Director of Hitonowa Medical and external executive officer of the company, presented the results of a prospective intervention study on ALS (Amyotrophic Lateral Sclerosis) using human dental pulp-derived stem cell conditioned medium (U-Factor® fluid), developed by the U-Factor Holdings group, at the 25th Annual Meeting of the Japanese Society for Regenerative Medicine held on March 20, 2026. This study (jRCTs031230731) is the world's first groundbreaking achievement demonstrating a new potential treatment for improving function in the intractable disease ALS. ALS is a progressive intractable disease where motor neurons degenerate, leading to muscle weakness throughout the body, and a fundamental cure is globally awaited. The academic presentation reported the safety and potential for functional improvement using U-Factor® fluid in this challenging area. U-Factor® fluid is a supernatant liquid produced during the culture of human dental pulp-derived stem cells. It is rich in "neurotrophic factors" that may contribute to improving ALS symptoms and has neuroprotective and immunomodulatory effects. Since it does not involve transplanting cells themselves, it is attracting attention as a simple and highly safe next-generation regenerative medicine. Key points of the study include the completion of the world's first prospective intervention study for systemic administration of U-Factor® fluid to ALS patients, and the verification of safety through 12 weeks of continuous administration. 8 patients received 120mL of stem cell conditioned medium intravenously once a week for a total of 12 weeks. No serious side effects were observed, indicating clinical safety. Efficacy evaluations (ALSFRS-R, grip strength, %FVC) showed improvement in respiratory function (%FVC) and suppression of progression in some cases, suggesting the possibility of functional recovery. U-Factor Holdings group plans to optimize and further verify stem cell conditioned medium therapy based on the findings from this study. They aim to accelerate social implementation to establish it as a standard treatment as soon as possible and are committed to providing new treatment options for patients suffering from intractable diseases, including ALS, and their families.