The Japanese stem cell and regenerative medicine oversight system is different than here in the U.S. and in Europe.
Japan has had a more permissive approach to overseeing regenerative medicine.
While most of the attention has focused on fairly legitimate regenerative biotechs and other sponsors in Japan, there are unproven stem cell clinics there. These clinics can take advantage of the system.
Even so, it’s rare to see news of a Japanese stem cell clinic getting hit by regulators. That’s why a new case is interesting.
Japanese stem cell clinic gets in hot water
Here’s the news: Fukuoka clinic issued business improvement order over stem cell treatments, The Japan Times.
This may not sound like much from the headline, but it is a striking case. From the article:
“The health ministry on Wednesday issued a business improvement order to a clinic in Fukuoka, saying a range of stem cell treatments it offers violate the law on the safety of regenerative medicine…Seijikai Fukuoka MSC Clinic, run by Dr. Kenji Fukamatsu, offers various stem cell treatments whose plans have not been submitted to the authorities, according to the ministry. The treatments include bone regeneration, skin care and therapies to combat cancer and preventing arteries from becoming hardened.”
What does it mean when a business like a medical clinic in Japan is issued a business improvement order? It means that authorities have found substantial problems that need fixing.
The marketing claims mentioned above like supposed bone regeneration and cancer therapies raise big red flags.
Seijikai Fukuoka MSC clinic claims
Here’s Google Translate’s translation of this clinic’s statements and claims on its website:
“Fukuoka MSC Medical Clinic is a clinic specialized in regenerative medicine. Regenerative medicine is a medical technology aimed at regenerating and repairing patients’ cells and tissues to restore function. It can treat damaged cells and tissues caused by diseases or injuries, and is expected to provide effective treatment methods for difficult diseases and chronic conditions that traditional treatments cannot address. These technologies contribute to the development of new treatments for various diseases such as diabetes, Parkinson’s disease, spinal cord injuries, and myocardial infarction. Fukuoka MSC Medical Clinic conducts daily research to help everyone achieve a better life through regenerative medicine in both medical and aesthetic aspects.”
More red flags.
There are no stem cell therapies for these conditions. Is the clinic being vague enough to mention it here without implying they actually treat it?
They also separately mention aging therapy and stem cell cosmetics.
American vs. Japanese stem cell systems
This Japanese MSC clinic made claims similar to many MSC clinics here in the U.S.
As is the case with a vast number of U.S. clinics not working with the FDA, Seijikai Fukuoka MSC Clinic reportedly did not work with authorities.
There’s a literature on the regenerative medicine oversight system in Japan. Recent papers suggest the framework is not working to ensure safety and efficacy. For example, check out this Cell Stem Cell paper: Too little, too soon: Japan’s experiment in regenerative medicine deregulation.
There’s also this Regenerative Medicine article: Japan and Australia’s online market for unproven stem cell treatments.
Other systems and looking ahead
This new paper Dark Clouds Looming Over Regenerative Medicine in Japan highlights problems with the standard pathway there and how regenerative products have failed in clinical trials.
Last summer I wrote about how regenerative medicine in Japan is often hyped in the media. Hype on stem cells and related products is not unique to Japan. However, overall due to multiple issues including their soft oversight system, Japan does face unique challenges.
This recent piece in Cell Stem Cell Effective regulatory responses to predatory stem cell markets in Australia and Canada highlights how well oversight systems can work.
Regulators in both the U.S. and Japan need to be more active, more proactive, and use creative approaches to deal with the unproven clinic problem. The U.S. is likely to face more clinic problems with HHS Secretary Kennedy seeming to be a friend of the clinics.
Overall, Japan is a leader in stem cell and regenerative medicine research, but I believe it must change its oversight system to be more rigorous.
The stem cell clinic situation seems worse here in the U.S., but I’m not optimistic about federal regulators helping things over the next four years. They may make things much worse. On the other hand, state attorneys general are having a positive impact.