Acu-Go® has been approved in Japan, ushering in a new era of rehabilitation in 2026!

The world’s first regenerative drug for brain injury, Acu-Go® (Vandefitemcel), has been approved in Japan and is expected to enter clinical use in 2026, bringing new hope for recovery to patients with traumatic brain injury (TBI).

Brain injuries are often caused by traffic accidents and falls, and may result in serious long-term complications such as paralysis, sensory impairment, and memory decline. Until now, there has been a lack of effective treatments specifically targeting chronic motor paralysis after brain injury.

Developed by Japan’s SanBio Co., Ltd., Acu-Go® is the world’s first allogeneic cell therapy approved to improve chronic motor paralysis following brain injury, and is regarded as a milestone “brain regenerative medicine.”

The therapy uses mesenchymal stem cells derived from the bone marrow of healthy donors. After cultivation and the introduction of the Notch-1 gene to enhance neural regeneration, the cells are precisely injected into the area surrounding damaged brain tissue via stereotactic neurosurgery.

These cells release growth factors such as FGF-2, promoting neural repair, regeneration, and differentiation, while also providing neuroprotection, supporting angiogenesis, and modulating the immune system.

The drug received conditional early approval in 2024. Recently, additional data were reviewed and approved by Japan’s Ministry of Health, Labour and Welfare, the restrictions have been lifted, and the product is expected to be officially launched soon. For patients suffering from chronic motor paralysis after brain injury, this marks a historic step forward in treatment.

Note:

The drug is currently approved only in Japan and is intended for patients with chronic motor paralysis following traumatic brain injury. Suitability must be determined by a qualified physician, and ongoing rehabilitation remains essential for improving quality of life.