What's the regulatory situation in Japan?

gh253

Member
I keep reading that Japan has already adopted a law similar to what REGROW proposes; when was it passed and what are the details? Has it yet resulted in any products getting on the fast track for approval in Japan?
 

barbara

Pioneer Founding member
http://www.stemcellpioneers.com/showthread.php?10104-Japan-seeks-leadership-role-in-stem-cell-medicine&highlight=japan

What is good in Japan is that the whole country seems to have come together in an effort to help patients and find cures. There is collaboration. Here in the U.S. there is too much money to be made. So many seem to be following that path, forgetting about the patients.

Here is an example of what's going on there -

RIKEN to resume retinal iPS transplant

June 07, 2016
Jiji Press

KOBE (Jiji Press) — The government-affiliated research institute RIKEN said Monday that it will resume its clinical study in which retinal tissues developed from iPS cells will be transplanted in an eye disease patient, in cooperation with Kyoto University and other medical institutes.

In 2014, the RIKEN Center for Developmental Biology, or CDB, successfully conducted a retinal transplant using induced pluripotent stem cells for the first time in the world. But its second trial was suspended due to a gene abnormality found in iPS cells.

In the first trial, iPS cells were created from cells taken from the patient who underwent the transplant.

Next time, the study team, led by Masayo Takahashi, project leader at the CDB, plans to use iPS cells created from mature cells of some others, since the first operation proved using a patient’s own cells is time-consuming and costly.

For the second trial, the CDB will develop retinal tissues from iPS cells supplied by Kyoto University’s Center for iPS Cell Research and Application, headed by Nobel laureate Shinya Yamanaka, the creator of the pluripotent cells.

Transplants of CDB-developed retinal tissues will be conducted at Kobe City Medical Center General Hospital and Osaka University Hospital.

The four institutes have signed an agreement to strengthen their collaboration. The partnership is “encouraging,” Takahashi said at a press conference on Monday. She expressed eagerness to carry out the next operation early next year.

Yamanaka said at the same news conference the he was heartened by the four institutes teaming up to push the study forward.Speech
 

SammyJo

Member
I keep reading that Japan has already adopted a law similar to what REGROW proposes; when was it passed and what are the details? Has it yet resulted in any products getting on the fast track for approval in Japan?
Yes, a Mesoblast product for GVHD has been approved in Japan.

Pricing was announced in Feb. 2016 for Mesoblast's graph-vs-host disease allogeneic product in Japan
"The Japanese Government’s National Health Insurance set reimbursement for Mesoblast' TEMCELL at ¥868,680 (approximately US$7,700) per bag of 72 million cells. Average adult patient is expected to receive at least 16 or up to 24 bags of 72m cells. Expected treatment course of TEMCELL in an adult patient to be reimbursed at a minimum of approx. US$123,000 or up to US$185,000."
http://investorsmedia.mesoblast.com/phoenix.zhtml?c=187006&p=RssLanding&cat=news&id=2142549&utm_content=buffer681f7&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
Link
 
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