Regenerative medicine (RM) involves the therapeutic application of cells, tissues and genes to repair or regenerate damage to the human body that has occurred as a result of disease or injury. The idea of regenerative readiness holds that, as well as developing new cell- and gene-based medicines, it is also necessary to improve institutional capacities and implement suitable infrastructure, training, and regulation, to make routine use of regenerative medicines in healthcare a viable prospect. (1) Much of the work of creating a suitable economic, regulatory and skills-based environment for regenerative medicines takes place at the national level.
Japan has engaged in a national, system-wide effort to build regenerative readiness. This takes the form of an All Japan collaboration between government, industry and academia to develop an ecosystem to make regenerative medicine viable. Japan has a long history of medical innovation, with robust state support for cell therapy since at least the year 2000.
This initially took the form of funding for medical research and the production of new regulatory guidelines for trialling cell therapies in clinical practice. Much of the recent effort has been propelled by the exuberance surrounding the discovery, and subsequent Nobel Award, for a novel type of stem cells, known as induced pluripotent stem cells, by Japanese scientists at the University of Kyoto. Hopes to capitalise on this technology of Japanese origin, and build a globally competitive industry, led to a range of initiatives across government, industry and academia to build a supportive ecosystem and advance system-wide readiness. (2)
As a highly regulated field, readiness efforts are perhaps most readily visible in government initiatives to facilitate industrial development and clinical delivery of RM. To this end, two new laws governing regenerative medicines were introduced in 2014: the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act (PMD Act) and the Act on the Safety of Regenerative (ASRM).
The PMD Act is the more conventional of the two laws. It is essentially an updating of the existing Pharmaceutical Affairs Law, to make explicit provision for RM products being developed by industrial producers for market access. This is similar to current regulatory pathways for RM medicinal products in the EU and USA, although the PMD Act does make special provision that allows regenerative therapies to be offered to certain patients on a for-profit basis before they have secured full regulatory approval. This conditional approval of regenerative therapies can be applied for after phase two clinical trials, if safety and efficacy are adequately predicted by existing trial data. The products are then required to establish safety and efficacy within a designated time, up to a maximum of seven years, after which their marketing approval can either be further extended or withdrawn.
The ASRM is more unusual in that it provides a second, parallel regulatory pathway for both research and clinical use of RM therapies in hospital settings. Clinical research covered by the ASRM is considered distinct from clinical trials run by companies, which are regulated under the PMD Act. This law was intended to bring private provision of unapproved cell and tissue-based products under control, while at the same time providing a structured framework to support clinical innovation as a valid way to develop new treatments in Japan. (3)
These regulatory adaptations were not made in a vacuum. The Japanese Society for Regenerative Medicine (JSRM) was highly instrumental in encouraging regulatory change, partly for Japanese scientists, who argued that the prevailing regulatory framework should be revised to accommodate the new technological modality. The JSRM is rather unique as an academic association in that has many industry members, and has also historically lobbied for government reforms in support of industry interests.
Industry has also been an integral part of building readiness in Japan. Developing industrial mass production capacity, thereby standardising the quality and lowering the prices of regenerative medicines, has long been considered important to the delivery and widespread adoption of RM therapies among a large population. The impetus for industrialisation has also been helped by the aforementioned desire to capitalise on a technology of national origin and develop a globally competitive industry.
As the membership of the Japanese industry association, FIRM, reflects, industry efforts to build the regenerative field are characterised by a cross-sector effort to build an eco-system. FIRM membership ranges from logistics providers to insurance companies and therapy developers. In addition to smaller start-ups working on cell or gene therapies, larger established firms from a range of sectors have entered the regenerative medicine field in Japan. These include Fujifilm, J-TEC (from medical device maker Nidek) and Terumo (another medical device company). (4)
This network building aspect is also seen in the work of the JSRM. The society is engaged in a range of readiness activities, such as match-making activities between academia and industry, engaging with patient organisations, and hosting public lectures to increase awareness of regenerative medicine. Indeed, recognising the importance of education and need to develop human capital (5), JSRM has established a training and certification programme for cell cultivation technicians, and published a regenerative medicine textbook targeted to all stakeholders involved in the field of regenerative medicine across the value chain.
Recent efforts by JSRM to promote readiness also include a national consortium to support clinical research and delivery of regenerative medicine, sponsored by AMED, Japans national medical research funding agency. The consortium includes activities beyond the clinical setting, such as education, advising on regulatory adjustments, and developing a national registry. The latter, referred to as the National Regenerative Medicine Database, records accumulated data from ongoing clinical research and post-marketing surveillance studies of regenerative therapies to generate a national resource of evidence on the safety and efficacy of RM treatments.
Readiness is context dependent (1), so some of the initiatives described will only make sense in the context of the existing Japanese regulatory and healthcare system. However, other readiness initiatives may act as useful examples for further countries to follow. In particular, clinical physician-led innovation is typically limited to surgical procedures, care provision pathways, and one off compassionate use interventions in much of the rest of the world, so it will be instructive to monitor whether the ASRM leads to a swathe of new regenerative treatment options in Japan.
(2) Umemura, M. and Morrison, M. (2021) Comparative lessons in regenerative medicine readiness: learning from the UK and Japanese experience. Regenerative Medicine 16(3): 269-282 0.2217/rme-2020-0136
(3) Takashima, K., Morrison, M. and Minari J. (2021). Reflection on the enactment and impact of safety laws for regenerative medicine in Japan. Stem Cell Reports, 16(6): 1425-1434.
(4) Umemura, M. (2019) Challenging the problem of fit: advancing the regenerative medicine industries in the United States, Britain and Japan. Business History 61(3): 456-480.
(5) Wyles, S.P. and Terzic, A. (2019) Building the regenerative medicine workforce of the future: an educational imperative. Regenerative Medicine 14(7): 613615.
*Please note: This is a commercial profile
2019. This work is licensed under aCC BY 4.0 license.
Editor's Recommended Articles
Read more here:
Japan: A case study of national readiness for regenerative medicine - Open Access Government
- The ISSCR announces 2024 election results - EurekAlert - March 28th, 2024
- Exosomes and Stem Cells Are the Future of Anti-Aging - NewBeauty Magazine - March 28th, 2024
- Charles River Extends Gene Therapy Alliance with NUS Medicine - Contract Pharma - March 22nd, 2024
- Exciting opportunities in stem cell technology and regenerative biology in Indian healthcare industry - Express Healthcare - March 22nd, 2024
- Charles River Announces Extension of Gene Therapy Manufacturing Alliance with NUS Yong Loo Lin School of Medicine - Yahoo Finance - March 22nd, 2024
- Opinion: The revolutionary sickle cell therapies - MSN - March 22nd, 2024
- 10 Years of Kansas Regenerative Medicine Center - KSAL - March 22nd, 2024
- BioCardia and StemCardia Announce Biotherapeutic Delivery Partnership - Diagnostic and Interventional Cardiology - March 17th, 2024
- Cynata Therapeutics' breakthrough in regenerative medicine - Finance News Network - March 17th, 2024
- New Positive Data Presented on Briquilimab Conditioning in Patients with Fanconi Anemia - GlobeNewswire - March 17th, 2024
- Novel 3D stem cell therapy to treat critical limb ischaemia - Drug Target Review - March 15th, 2024
- Breaking Boundaries: Pharmicell's Bold Vision for Healthcare Transformation and Monumental Growth - The Worldfolio - March 15th, 2024
- CuSTOM Organoid Research Evolving From Tool to Treatment - Research Horizons - Research Horizons - March 15th, 2024
- BioCardia and StemCardia Announce Partnership to Deliver Cell-Gene Therapy for Remuscularization of Heart - Cath Lab Digest - March 15th, 2024
- Calidi Biotherapeutics and City of Hope Announce Funding from the California Institute for Regenerative Medicine ... - Business Wire - March 13th, 2024
- Iron restriction keeps blood stem cells young, researchers find - Phys.org - March 13th, 2024
- Vitamin A could have a key role in both stem cell biology and wound healing: Study - Medical Dialogues - March 9th, 2024
- Trends in Stem Cell Transplantation Refusal for Myeloma Treatment - Targeted Oncology - March 7th, 2024
- Stem Cell Therapy Market (CAGR) of 31.1%, Future of Market Size Emerging Technologies and their Impact on ... - Taiwan News - March 7th, 2024
- This Swedish startup wants to reduce the cost, and controversy, around stem cell production - TechCrunch - March 6th, 2024
- Advancing stem cell therapy: The regulatory process to get to clinical trials - The Economic Times - March 6th, 2024
- Transitioning from traditional surgical methods to the innovative use of stem cells - pharmaphorum - March 6th, 2024
- 'Mini organs' are grown from human stem cells taken during the late stages of pregnancy for the first time - m - Daily Mail - March 6th, 2024
- Stem cell transplant cures man of HIV and leukemia, one of five to achieve full remission - Fox 28 - March 3rd, 2024
- Stem Cell Therapy Market to Boost USD 137.5 Billion by 2034 and Projected to grow at 32.10% CAGR with increasing ... - Yahoo Finance - March 1st, 2024
- Studies expand use of stem cell therapies - WPLG Local 10 - March 1st, 2024
- Innovative therapy targets and destroys leukemia stem cells - News-Medical.Net - February 27th, 2024
- Unlocking the Potential of Stem Cells: The Medical Revolution of the Century - EIN News - February 27th, 2024
- Pelage Pharmaceuticals Announces $16.75M Series A Financing led by GV to Revolutionize Regenerative Medicine ... - Yahoo Finance - February 27th, 2024
- Say Her Name - Henrietta Lacks, The Real Mother Of Stem - Her Campus - February 27th, 2024
- California Man Free of HIV And Cancer in Astonishing Medical Recovery - ScienceAlert - February 25th, 2024
- $93 million for research into improved health for children, young people and the aged, medical devices, mental health ... - Department of Health - February 25th, 2024
- Stem Cells in Regenerative Medicine - PMC - National Center for ... - February 24th, 2024
- The Promise and Reality of Stem Cell Therapy: What You Need to Know - Corporate Wellness Magazine - February 22nd, 2024
- Stem Cell Therapy: A Beacon of Hope for Patients with Untreatable Conditions - Corporate Wellness Magazine - February 22nd, 2024
- Leading Experts in Stem Cell Therapy: A Global Overview - Corporate Wellness Magazine - February 22nd, 2024
- Can Stem Cells Help Reverse the Effects of Aging? - Corporate Wellness Magazine - February 22nd, 2024
- Stem Cell Therapy for Cancer: Hope on the Horizon? - Corporate Wellness Magazine - February 22nd, 2024
- Stem Cells and Autism: A Closer Look at Innovative Treatments - Corporate Wellness Magazine - February 22nd, 2024
- Regrowth and Restoration: The Science Behind Stem Cell Therapy for Hair - Corporate Wellness Magazine - February 22nd, 2024
- Brain Recovery: The Role of Stem Cells in Stroke and Cerebral Palsy Treatments - Corporate Wellness Magazine - February 22nd, 2024
- Turning Back the Clock: The Science of Stem Cells in Anti-Aging - Corporate Wellness Magazine - February 22nd, 2024
- Insights into cellular therapies for cancer treatment - Drug Target Review - February 22nd, 2024
- The Role of Stem Cells in Rheumatoid Arthritis Recovery - Corporate Wellness Magazine - February 22nd, 2024
- Dr Ernesto Romeros vision transforms immunotherapy regenerative medicine into a global leader in stem cell treatment - Khaleej Times - February 22nd, 2024
- World-Renowned Doctors Leading the Way in Stem Cell Research and Treatment - Medical Tourism Magazine - February 20th, 2024
- Choosing the Best: A Guide to America's Premier Stem Cell Therapy Providers - Medical Tourism Magazine - February 20th, 2024
- Navigating Through the Possibilities of Stem Cell Treatment for Eye Disorders - Medical Tourism Magazine - February 20th, 2024
- Global Leaders in Stem Cell Therapy: Where Excellence Meets Innovation - Medical Tourism Magazine - February 20th, 2024
- Excellence in Stem Cell Treatment: How the US is Pioneering Global Healthcare Solutions - Medical Tourism Magazine - February 20th, 2024
- Clarifying Memory Loss Treatments: The Role of Stem Cells - Medical Tourism Magazine - February 20th, 2024
- Battling Inflammation: Stem Cell Therapy for Rheumatoid Arthritis - Medical Tourism Magazine - February 20th, 2024
- Digestive Health and Stem Cells: Treating Ulcerative Colitis and Crohn's Disease - Medical Tourism Magazine - February 20th, 2024
- Top Stem Cell Clinics in the USA: Pioneering Treatments for Chronic Conditions - Medical Tourism Magazine - February 20th, 2024
- Stem Cells and Autism: Understanding the Potential for Innovative Treatments - Medical Tourism Magazine - February 20th, 2024
- Stopping the awakening of sleeping Acute Myeloid Leukaemia stem cells to prevent disease relapse - University of Birmingham - February 20th, 2024
- City of Hope Achieves Ground Breaking Treatment for Blood Cancer and HIV - Medriva - February 18th, 2024
- Regenerative Medicine Market Size to Worth USD 95 Billion by 2032 - InvestorsObserver - February 18th, 2024
- North America Organoids Market Projected to Reach US$ 5.35 Billion by 2030, Riding on a CAGR of 21.5% - GlobeNewswire - February 18th, 2024
- Chinese team tests lung treatment that may be first to reverse COPD damage - South China Morning Post - February 15th, 2024
- Why leukemic stem cells not harmed by chemotherapy begin to grow and produce AML cells after treatment - Medical Xpress - February 15th, 2024
- Regenerative Medicine Market is Expected to Reach $49.0 Billion | MarketsandMarkets - Yahoo Finance - February 15th, 2024
- Study finds interleukin-24 enhances CAR-T cell therapy's effectiveness against cancer stem cells - News-Medical.Net - February 15th, 2024
- Oldest Patient 'Cured' of HIV Still in Remission 5 Years After Transplant for AML - Medpage Today - February 15th, 2024
- Drug used for cocaine addiction may pave way for new treatment of advanced colon cancer - EurekAlert - February 15th, 2024
- Hematopoietic Stem Cells and Their Role in Development and Disease Therapy - The Scientist - February 15th, 2024
- Biomedical Researcher Seeks to Improve Outcomes in Stem Cell Treatments - University of Arkansas Newswire - February 13th, 2024
- Top 3 grants in regenerative medicine: January 2024 - RegMedNet - February 13th, 2024
- Scalise returning to Washington next week with cancer in complete remission - The Hill - February 13th, 2024
- Unlocking the power of stem cell therapy - Drug Target Review - February 9th, 2024
- Digging into the Dangers of Gene Therapy - The Medicine Maker - February 7th, 2024
- Treating and preventing abnormal heart beats with stem cell muscle grafts - Medical Xpress - February 7th, 2024
- Regeneration of the Retina Using Pluripotent Stem Cells: A Comprehensive Review - Cureus - February 3rd, 2024
- I thought I'll give it a chance - Liam Harrison reveals his thought process in getting crucial stem cell treatment - Sportskeeda - February 3rd, 2024
- Jennifer J. Raab named President and CEO of The New York Stem Cell Foundation - EurekAlert - February 3rd, 2024
- High-dose chemotherapy and autologous haematopoietic stem-cell transplantation in older, fit patients with primary ... - The Lancet - January 31st, 2024
- Houston regenerative medicine company to IPO, move toward more human trials - InnovationMap - January 31st, 2024
- New study on promising stem cell-based therapy for Crohn's disease - Medical Xpress - January 31st, 2024
- Exploring pharmacological, non-pharmacological, and stem cell therapies for treatment of autism spectrum disorders - News-Medical.Net - January 29th, 2024
- Stem cell study shows how gene activity modulates the amount of immune cell production in mice - Medical Xpress - January 26th, 2024
Recent Comments