for some more insight into japans new cell based regenerative therapy approval process - a new alzheimers stem cell therapy has been approved:
According to Nature Cell, Kyushu’s conditional approval review board for regenerative medicine has approved Fukuoka Trinity Clinic’s request to begin offering Astro Stem to interested patients. The decision was also delivered to Japan’s Ministry of Health, Labor and Welfare.
As a result, the hospital -- a partner of the Biostar Research Institute jointly run by Nature Cell and R Bio -- will be able to start offering the firm’s stem cell therapies to patients within this month, it said.
In Japan, stem cell therapies are not considered drugs, but fall under therapeutic technology.
To begin providing stem cell therapies, a hospital must obtain the approval of a board of regenerative medicine specialists who review the drugs’ efficacy and safety, as well as patient risks and benefits.
Once approval is granted, it is delivered to the Japanese Drug Ministry for recordkeeping. Then, the hospital can begin commercially offering the stem cell treatments to patients at the facility.
and this article elaborates even more: https://www.businesswire.com/news/h...ure-Cell-Biostar-Stem-Cell-Research-Institute
seems the original IN MOUSE research was published in 2012, and then treatment is now being released commercially 6 years later. in comparison, tsujis first journal publication of his method was in 2012 (https://www.nature.com/articles/ncomms1784). someone can do some more research to find when they started clinical trials to get a more accurate insight into when tsujis method could be released
According to Nature Cell, Kyushu’s conditional approval review board for regenerative medicine has approved Fukuoka Trinity Clinic’s request to begin offering Astro Stem to interested patients. The decision was also delivered to Japan’s Ministry of Health, Labor and Welfare.
As a result, the hospital -- a partner of the Biostar Research Institute jointly run by Nature Cell and R Bio -- will be able to start offering the firm’s stem cell therapies to patients within this month, it said.
In Japan, stem cell therapies are not considered drugs, but fall under therapeutic technology.
To begin providing stem cell therapies, a hospital must obtain the approval of a board of regenerative medicine specialists who review the drugs’ efficacy and safety, as well as patient risks and benefits.
Once approval is granted, it is delivered to the Japanese Drug Ministry for recordkeeping. Then, the hospital can begin commercially offering the stem cell treatments to patients at the facility.
and this article elaborates even more: https://www.businesswire.com/news/h...ure-Cell-Biostar-Stem-Cell-Research-Institute
seems the original IN MOUSE research was published in 2012, and then treatment is now being released commercially 6 years later. in comparison, tsujis first journal publication of his method was in 2012 (https://www.nature.com/articles/ncomms1784). someone can do some more research to find when they started clinical trials to get a more accurate insight into when tsujis method could be released