A clinic told me its exosome therapy is “approved by the Japanese government.” Is that true?

Ask which approval and for the number. For stem cell treatment there is a filing you can check on the public register. For exosomes and supernatant no such filing exists, and the health ministry has stated there is no pharmaceutical approval. A claim of approval needs to be substantiated with a specific document.

Is exosome therapy illegal in Japan then?

No. It is outside the scope of the Act on the Safety of Regenerative Medicine, which is different from being prohibited. Legal and reviewed are two separate things, and only one of them is verifiable by you.

Exosomes: the treatment with nothing to check

This is the most heavily marketed treatment to overseas visitors, and the one where the verification method described everywhere else on this site simply does not apply. Not because it is banned, but because it sits outside the law that creates the register.

Why stem cell treatment is on the register and this is not

The Act on the Safety of Regenerative Medicine covers the administration of cells. A clinic administering stem cells must file a provision plan, have it reviewed by a certified committee, and appear on the public register.

Culture supernatant is the liquid left after culturing stem cells, with the cells removed. Exosomes are a component of it. Because no cells are administered, these fall outside that Act. There is no filing, no committee review, and nothing for you to look up.

What the health ministry has said

The Ministry of Health, Labour and Welfare has stated that no product of this kind holds pharmaceutical approval in Japan. Outside the register does not mean illegal — it means unregulated by that particular framework, which is precisely the problem when you are trying to verify something from abroad.

The price gap is misleading

A single supernatant session typically costs a fraction of stem cell treatment. That gap reads as “the same thing, cheaper.” Institutionally they are not the same thing at all, and the difference in what you can verify is total.

In our review, only 21 of the 217 clinics offering supernatant published who manufactures it and what testing was done. For roughly nine in ten, you cannot establish in advance what is being put into you.

Four questions to ask instead

Who manufactures this product, by name. What sterility and virus testing was performed, and can you see the results. What is the cell source — adipose, umbilical cord, dental pulp — and was the donor screened. Which hospital do they transfer you to if something goes wrong.

All four should be answerable in writing. An inability to answer any of them is itself information.

Check a clinic on the register

Common questions

A clinic told me its exosome therapy is “approved by the Japanese government.” Is that true?: Ask which approval and for the number. For stem cell treatment there is a filing you can check on the public register. For exosomes and supernatant no such filing exists, and the health ministry has stated there is no pharmaceutical approval. A claim of approval needs to be substantiated with a specific document.
Is exosome therapy illegal in Japan then?: No. It is outside the scope of the Act on the Safety of Regenerative Medicine, which is different from being prohibited. Legal and reviewed are two separate things, and only one of them is verifiable by you.

Sources: Act on the Safety of Regenerative Medicine; Ministry of Health, Labour and Welfare notice on medical care using stem cell culture supernatant and exosomes (administrative communication, 31 July 2024); our own review of clinic websites.

This page is a summary for visitors from outside Japan. The Japanese pages are the authoritative version and are kept more current. All figures come from the Ministry of Health, Labour and Welfare register and from our own review of clinic websites.