Category Archives: Shinya Yamanaka

Japan’s New Laws to Fast Track Stem Cell Therapies

Japan has been at the forefront of regenerative medicine research for a number of years, partly due to the fact that its population is rapidly aging and declining too. The country is also at the forefront of robotics related research for similar reasons. A 2013 article from Japan projected stellar growth in the local regenerative medicine sector.

Japan’s Fast Tracking of Stem Cell Therapies

On November 20th 2013, Japan’s parliament passed two groundbreaking laws that aim to speed up the approval process for regenerative medicine involving stem cells.

One of the country’s foremost scientists, Dr. Shinya Yamanaka (together with Dr. John Gurdon), received a Nobel Prize in 2012 for his discovery on how to transform ordinary adult skin cells into cells that act like embryonic stem cells and can then develop into virtually any other type of cell in the body. Dr. Yamanaka called these cells induced pluripotent stem cells, or iPS cells.

Japan is now leading the world in this area. The country’s scientists have undertaken many pioneering procedures in recent years to restore eyesight using iPS cells.

What does all this mean when it comes hair loss research?

Time consuming stage III clinical trials that we see in the US will essentially be skipped in Japan. Especially for autologous procedures. This is excellent news, especially since Shiseido (Japan) will be starting stage II clinical trials of Replicel (Canada)’s RHC-01 product in the first half of 2015. These trials will last for one year, and it is therefore even possible that Shiseido can bring this product to market in Japan as early as 2017. This is a best case scenario of course and assumes the the stage II trials show good results.

Japan is holding the important BioJapan 2014 World Business Forum this coming week, and Replicel is scheduled to present there on October 15, 2014. More importantly, Replicel’s team “will be meeting with Shiseido to discuss progress on their RCH-01 clinical trial and to view their purpose-built facility on Kobe Island.”

I have mentioned this a few times before on this blog, and will repeat. We in the west will likely have to travel to Asia when the treatment finally arrives, even if it is based on western technology.