A Japanese medical institution, in a first for the country, will seek government approval for using embryonic stem cells as a regenerative medicine product to treat babies with a severe liver ailment, sources close to the matter said Monday.
The step toward commercialization of the treatment comes after the National Center for Child Health and Development confirmed its safety and efficacy in a clinical trial between October 2019 and December 2021.
If the application, to be made by March 2024, is approved, the treatment could be available as early as fiscal 2024, which starts. Outside of Japan, embryonic stem cells have been used in clinical trials to treat conditions such as eye diseases and spinal cord injuries, but there have yet to be any reports of commercial use.