SanBio Co. Ltd has received approval in Japan for “AKUUGO® Suspension for Intracranial Implantation,” a groundbreaking cell-based therapy for improving chronic motor paralysis resulting from traumatic brain injury (TBI).

TBIs, caused by external forces like accidents or falls, can damage brain tissue, leading to motor and cognitive impairments. Despite extensive research, brain tissue regeneration in chronic TBI patients has been elusive, posing a significant medical challenge.

AKUUGO® is the first allogeneic cell therapeutic agent approved for TBI-related motor paralysis. Derived from healthy donor bone marrow, AKUUGO® involves enhancing mesenchymal stem cells’ regenerative capabilities through gene transfection.

Transplanted into damaged brain tissue, AKUUGO® releases substances that stimulate the natural regenerative capacity of nerve cells. It has been shown to protect nerve cells, promote angiogenesis, and modulate immune responses.

Clinical trials conducted in Japan and the United States demonstrated AKUUGO®’s effectiveness in improving motor function in TBI patients. Dr. Nobuhito Saito, Professor of Neurology at the University of Tokyo, stated, “AKUUGO® offers a novel approach to TBI treatment, targeting the underlying damage and promoting regeneration.”

AKUUGO® marks a significant advancement in regenerative medicine, paving the way for potential treatments for other neurological conditions. Its approval is a testament to the dedication of researchers and clinicians in addressing the unmet needs of patients with traumatic brain injuries.

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.