Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2022 Nov 28;11(23):7030.
doi: 10.3390/jcm11237030.

Clinical Trials of Stem Cell Therapy in Japan: The Decade of Progress under the National Program

Shin Enosawa  1
Affiliations
Review

Clinical Trials of Stem Cell Therapy in Japan: The Decade of Progress under the National Program

Shin Enosawa. J Clin Med. .

Abstract

Stem cell therapy is a current world-wide topic in medical science. Various therapies have been approved based on their effectiveness and put into practical use. In Japan, research and development-related stem cell therapy, generally referred to as regenerative medicine, has been led by the government. The national scheme started in 2002, and support for the transition to clinical trials has been accelerating since 2011. Of the initial 18 projects that were accepted in the budget for preclinical research, 15 projects have begun clinical trials so far. These include the transplantation of retinal, cardiac, and dopamine-producing cells differentiated from human induced pluripotent stem (iPS) cells and hepatocyte-like cells differentiated from human embryonic stem (ES) cells. The distinctive feature of the stem cell research in Japan is the use of iPS cells. A national framework was also been set-up to attain the final goal: health insurance coverage. Now, insurance covers cell transplantation therapies for the repair and recovery of damaged skin, articular cartilage, and stroke as well as therapies introduced from abroad, such as allogeneic mesenchymal stem cells for graft-versus-host disease and chimeric antigen receptor-T (CAR-T) cell therapy. To prepare this review, original information was sought from Japanese authentic websites, which are reliable but a little hard to access due to the fact of multiple less-organized databases and the language barrier. Then, each fact was corroborated by citing its English version or publication in international journals as much as possible. This review provides a summary of progress over the past decade under the national program and a state-of-the-art factual view of research activities, government policy, and regulation in Japan for the realization of stem cell therapy.

Keywords: ES cell; Japan; clinical trial; health insurance; iPS cell; regulation; stem cell; transplantation.

PubMed Disclaimer

Conflict of interest statement

The author declares no conflict of interest.

References

    1. Cantor C.R. Biotechnology in the 21st century. Trends Biotechnol. 2000;18:6–7. doi: 10.1016/S0167-7799(99)01394-3. - DOI - PubMed
    1. Submission of Final Report by the Biotechnology Strategy Council. Friday. [(accessed on 17 October 2022)];2002 December 6; Available online: https://japan.kantei.go.jp/koizumiphoto/2002/12/06bt_e.html.
    1. Priority Strategies for Science and Technology. [(accessed on 17 October 2022)]; Available online: https://www.mext.go.jp/en/publication/whitepaper/title03/detail03/sdetai....
    1. Strategies for the Development of Biotechnology. [(accessed on 17 October 2022)]; Available online: https://warp.da.ndl.go.jp/info:ndljp/pid/998223/www.kantei.go.jp/jp/sing.... (In Japanese)
    1. Research Center Network for Realization of Regenerative Medicine. [(accessed on 17 October 2022)]; Available online: https://www.jst.go.jp/saisei-nw/en/document/saisei-nw_2015_en.pdf.

LinkOut - more resources