Both Japan’s regenerative medicine framework and the system of FDA-centric oversight here in the US have allowed large numbers of unproven stem cell clinics to flourish.
While the US stem cell clinic problem has gotten major attention, many in the field may not realize that there may be hundreds of unproven clinics that offer biologics in Japan.
Sadly, a woman there has just died after getting an adipose cell procedure at an unproven clinic.
What’s going on?
Death related to unproven regenerative medicine from clinic in Japan
Leading stem cell biologist Masaya Takahashi tweeted about this event and the news popped up on Reddit too.
Here’s a Twitter translation of part of Dr. Takahashi’s posts:
“There is no evidence that treatments that have not gone through such clinical studies are effective. However, I repeatedly pointed out in the Ministry of Health, Labor and Welfare’s committees that it is problematic that they are permitted through a nominal review by the certification committee under the Act on the Safety of Regenerative Medicine, etc., and are listed as registered clinics on the Ministry of Health, Labor and Welfare’s homepage, but since they are legally recognized, nothing was done about it. In the end, a fatal accident occurred.”
and on the death itself:
“A woman in her 50s suddenly deteriorated during regenerative medicine treatment and later died. An emergency order to temporarily suspend medical services was issued to a clinic in Chuo Ward, Tokyo. This is the first emergency order due to a patient’s death during regenerative medicine treatment. Ministry of Health, Labor and Welfare (TBS NEWS DIG Powered by JNN).”
The clinic, Tokyo Science Clinic, is claiming it was anaphylactic shock. However, the cause remains unclear and could have been due to the cells. A place called Kohjin Bio Saitama Cell Processing Center produced the cellular product.
The regenerative medicine oversight system in Japan has a unique conditional approval component that has been worrisome. It allows for early approval with relatively little data.
It’s possible that regulators there are stepping up activity: also see from earlier this year: Japanese stem cell clinic oversight: the case of MSC clinic Seijikai Fukuoka.
Data on unproven regenerative medicine clinics in Japan
Researchers in Japan including Misao Fujita and Keiichi Tobita have published important work on regenerative medicine oversight there. A hat tip to a friend who pointed me to two relevant papers:
- Difficulties in ensuring review quality performed by committees under the Act on the Safety of Regenerative Medicine in Japan, Stem Cell Reports.
- Amendments to ASRM: Can we move away from a “Therapeutic Haven”?, Stem Cell Reports.
The papers identified issues with Japan’s oversight system and documented the scope of the clinic problem there. They also highlighted additional relevant, adverse events that have occurred such as:
“On June 1, 2024, it was reported that at least three patients at the same private clinic who received intravenous infusions of adipose-derived mesenchymal stem cells for menopausal symptoms and ovarian dysfunction developed primary visual impairment.”
How to devise better oversight for cellular therapies?
It’s remarkable that two leading countries working on regenerative medicine research, Japan and the U.S., have in their own ways become havens for unproven clinics.
Both countries need to figure out creative approaches to this problem. In theory the US is stricter than Japan on this front, but our clinic problem seems more severe. The FDA has struggled to address the clinic industry effectively.
Things could get worse here too. The trend in the US of new permissive state stem cell laws specifically allowing non-FDA-approved stem cell therapies plus HHS Secretary RFK Jr.’s interest in unproven stem cells could lead to more clinics selling risky offerings.
Fans of the risky American state stem cell laws also like to point to Japan as having an idealized system that the US should emulate, but I don’t think either system is working very well. Conditional approval has serious downsides if not handled extremely carefully.
Leading regenerative medicine researchers from multiple countries should put their heads together to come up with more effective, practical solutions. No one system will work in every country, but maybe there are common ideas that could be shared.
That’s a disturbing but important read. The tragic death in Japan really highlights how dangerous it is when unproven regenerative medicine slips through regulatory gaps. Conditional approvals may sound progressive, but without strong oversight, patients become test subjects with their lives at stake. The fact that both the U.S. and Japan—leaders in research—still allow these risky clinics to operate shows how complicated and urgent the problem is. Stronger global collaboration and stricter accountability seem absolutely necessary before more people are harmed.
Thanks for keeping us current about this problem, Paul. It is such a waste. Masayo is taking a risk by being critical, and I hope it doesn’t affect her efforts at developing evidence-based iPSC-derived cell replacements. We need more scientists to be outspoken about these useless treatments.