We urge the Pharmaceutical Affairs and Food Sanitation Council's Subcommittee on Regenerative Medicine Products of the Japanese Ministry of Health, Labour, and Welfare to reconsider their decision to decline approval for SanBio's revolutionary mesenchymal stem cell transplant therapy for chronic Traumatic Brain Injury (TBI) (also known as SB623 or AKUUGO Suspension for Intracranial Implantation).

As someone who has personally battled TBI for 6.5 years, I am not affiliated with SanBio in any way, but I stand in solidarity with countless others who are desperate for relief from this debilitating condition.

SanBio's treatment has demonstrated remarkable efficacy in Phase I and II trials, prompting the company to seek provisional approval through Japan's Sakigake system. The urgent need for this breakthrough therapy to be accessible cannot be overstated.

Globally, an estimated 55 million individuals suffer from Traumatic Brain Injury, imposing significant economic burdens, with costs in the United States alone exceeding $400 billion annually.

So why are we petitioning Japan?

Japan holds the pivotal role of being the only country poised to approve this transformative treatment. Once approved by Japan, it will pave the way for Expanded Access programs in other countries, including the United States, offering hope to millions worldwide.

The effects of TBI vary widely among individuals. In my case, it manifests as chronic dystonia, causing involuntary muscle contractions and releases in both upper and lower extremities, alongside hemiplegia, resulting in paralysis on one side of the body. Without proper treatment over time, this condition can lead to irreversible muscle and joint deformities. I count myself fortunate, as for others, TBI can lead to far more severe outcomes, such as chronic/persistent vegetative states.

Your support can make a difference in the lives of those grappling with TBI. Please sign and share this petition to urge Japan to grant approval for SanBio's life-saving therapy. Thank you for standing with us in this critical cause.