Japanese regulations on regenerative medicine are failing patients

Many nations across the world, including Japan, are making significant investments in regenerative medicine. This is largely due to its potential to cure people of spinal injuries, recover from strokes, among other various anticipated benefits. However, it is growingly becoming difficult for patients to unambiguously distinguish regenerative medical therapies that are medically-proven from those still undergoing scientific investigations. To overcome these issues, in 2014, Japan passed the Act on the Safety of Regenerative Medicine (ASRM)^*. However, a new study in Cell Stem Cellby Professor Misao Fujita and colleagues investigated the types of regenerative medicine being performed under the ASRM in Japan and found that revisions are necessary if it is to effectively prevent patients from mistakenly selecting unproven treatments. 

Among regenerative medicines, applications of cell therapies have generated the most interest. Japan’s strength in stem cell research has pushed the country to aggressively fund all kinds of cell therapies in hopes of curing intractable diseases and putting Japan at the forefront of this potentially revolutionary patient care. 

Indeed, many countries have seen extraordinary promise in cell therapies, but so too have many unethical clinics, which has led to serious complications and even death in over a dozen countries including Japan. 

“The ASRM requires any provision plan for a therapy be accompanied by explanatory and informed consent documents. In 2017, revisions to the act required these documents be published on the MHLW (Ministry of Health, Labor and Welfare) website,” said Fujita.

In the study, Fujita and colleagues referred to the MHLW website for information about clinics offering cell interventions in Japan, collecting explanatory and informed consent documents on 3467 provisional plans in total.

Alarmingly, the study found there were treatments on the website that would be subjected to international criticism. The study cautioned three structural issues in ASRM: the absence of scientific verification requirement, the failure to distinguish research from treatments, and the absence of any clearly definition for medical innovations and unproven interventions. 

“The ASRM does not prohibit interventions so long as they follow the procedures stipulated by law,” said Fujita. 

In other words, even if a treatment is scientifically unproven, it can be administered. Moreover, she worried, its presence on the MHLW website may provide what she calls a “seal of approval” that the treatment is safe and effective even when it actually is not. 

Moreover, 2% of the examined plans failed to include the required explanatory documents, putting further doubt into the quality of the review process.

For Fujita, the study shows that the ASRM should address at least these three points before patients can be confident about the cell therapies provided under this law.

“The ASRM has already gone revisions. We wish our study will guide more changes to strengthen its quality,” she said.

* The Act on the Safety of Regenerative Medicine (ASRM) targets to regulate medical practices that aim to achieve the “reconstruction, repair, or formation of human body structures or functions” or the “therapy or prevention of human disease or illness” and that use “processed cells” (excluding blood transfusion, hematopoietic stem-cell transplantation, and assisted reproductive technology). 

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Institute for the Advanced Study of Human Biology (ASHBi) was launched in October 2018 with funding from the World Premier International Research Center Initiative (WPI) Program of the Ministry of Education, Culture, Sports, Science and Technology (MEXT). The Institute inaugurated with 18 principal investigators (PIs) to create and promote human biology to elucidate key principles of human traits, including disease states. The Institute will perform interdisciplinary research between biology and mathematics (machine learning and topological data analysis) and between biology and humanities/social sciences (bioethics and philosophy on life), respectively. The Institute implements three research development cores for cutting-edge single-cell genome information analysis, primate genome editing, and non-human primate phenotype analysis, respectively. The Institute establishes a link with international institutions such as the EMBL, University of Cambridge, and Karolinska Institutet, creating a stratified organization for research promotion and strengthening its international profile.