Regenerative Medicine in Japan: The Regulation, and How to Check a Clinic Yourself

Stem cell therapy and PRP therapy in Japan are governed by the Act on the Safety of Regenerative Medicine, even when provided as fully private-pay treatment. Every clinic must pass review by a certified committee, file a treatment plan with the Minister of Health, Labour and Welfare, and receive a registration number. Importantly, this registration confirms the safety of the delivery system — it is not a government guarantee of effectiveness.

Note: this article is provided for general information only. Outcomes vary between individuals.

• ✓How one law applies the same procedure to both research and private-pay practice
• ✓What registration confirms — and what it does not
• ✓Why approved products and private-pay treatment are two separate systems
• ✓Four things you can verify yourself, plus the process from arrival to treatment

1. Regenerative medicine in Japan sits inside a dedicated law

Japan enacted the Act on the Safety of Regenerative Medicine in November 2013, and it took effect on 25 November 2014.

This matters because of what it covers. In many countries, regulatory attention focuses on cell-based products — manufactured items that must be approved before sale. Treatments performed by a physician using a patient’s own cells often fall outside that framework.

Japan took a different approach: any regenerative treatment, whether research or private-pay clinical practice, must go through the same procedure.

The five steps every clinic must complete

Three risk classes

Treatments are sorted into three risk classes, and the class determines which committee must review the plan.

The framework continues to expand. An amendment (Act No. 51 of 2024) was promulgated on 14 June 2024 and took effect on 31 May 2025, extending the law’s scope from cell-processed products to in vivo gene therapies that do not involve processed cells.

2. What registration confirms — and what it does not

This distinction is often blurred, so it is worth stating plainly.

The Ministry’s own published list describes the review as covering safety and related matters — not efficacy. What has been examined is the integrity of the delivery system, not whether the treatment works.

So if a clinic tells you “we are registered, therefore the results are assured,” that reasoning does not hold.

At first glance this may look like an argument against regenerative medicine. In practice it is the opposite. Once you separate “is it registered?” from “what is the evidence?”, you have two distinct questions to ask — and a far better basis for choosing a clinic.

3. Approved products and private-pay treatment are two different systems

Japan has a second pathway: approval of regenerative medicine products under the Pharmaceuticals and Medical Devices Act. In 2014 the country introduced conditional and time-limited approval, allowing products to reach patients once safety is confirmed and efficacy is reasonably inferred.

According to the Regenerative Medicine Portal operated by the Japanese Society for Regenerative Medicine, approved products as of 7 July 2026 include:

These products completed clinical trials and national review, and their use is restricted to specified conditions and institutions. This is a different system, with a different evidentiary standard, from private-pay regenerative medicine.

This also gives you something concrete to watch for. If a clinic presents trial data from an approved product as though it supported its own private-pay treatment, that distinction has been lost.

4. Four things you can verify yourself

The International Society for Stem Cell Research (ISSCR) has consistently warned about stem cell treatments marketed without adequate testing or regulatory approval. The literature notes that receiving unregulated treatment may disqualify a patient from future participation in legitimate clinical trials, and case reports describe serious adverse events, including deaths.

This is not a problem confined to any one country. Rather than comparing countries, it is more reliable to have a method of verification. Under Japan’s framework, the following four points are things you can check yourself.

1Check the registration number — and check that your treatment is covered by it

The first thing to understand is that registration is filed separately for each treatment. Within a single clinic, joint treatment and scalp treatment carry different numbers. If a clinic offers one number and says “everything we do is registered,” ask which treatment that number actually corresponds to.

The Ministry of Health, Labour and Welfare publishes a list of filed provision plans, allowing you to cross-check clinic names against treatment content. As noted above, publication depends on the clinic’s consent, so not every plan appears there.

2Check that the physician’s qualifications match the body area

Regenerative medicine crosses several specialties. Knee treatment requires orthopaedic judgement — the degree of degeneration, the state of the meniscus and ligaments, whether surgery would in fact be the better option. Skin and hair involve an entirely different assessment framework.

What matters is not whether a physician is “experienced in regenerative medicine” in general, but whether they hold a specialist qualification relevant to the area being treated. The Japanese Society for Regenerative Medicine also operates a certification system you can check.

3Check where cell processing takes place

Cell processing facilities require separate authorisation or registration. Where processing is outsourced, the external facility must hold authorisation; where a clinic processes cells itself, it must file a registration.

4Check whether they explain what the treatment cannot do

This is the most practical test of all. A proper explanation covers who is and is not a candidate, possible side effects, how many sessions are needed and at what intervals, how much outcomes vary between individuals, and what the next option is if the treatment does not work.

If a consultation consists only of positives and you are pushed to decide the same day, that in itself tells you something.

A free consultation is the simplest way to find out whether treatment is appropriate for your situation.

Suitability cannot be established from an article. It is determined by a physician after examination and imaging.

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5. Scope, suitability, risks and costs

Treatments outside the registration framework

We also offer treatments using iPS cell-derived exosomes and umbilical cord-derived stem cell secretome. These are not classified as processed cell products and therefore fall outside the provision plan registrations listed above. They are private-pay treatments using unapproved pharmaceuticals — see the notice at the end of this article.

Registration numbers should not be read as covering an entire treatment menu, and we think clinics should say so without being asked.

Suitability requires an in-person assessment

Broadly speaking, patients with knee pain that has not improved sufficiently with conservative care — exercise therapy, hyaluronic acid injections — but who have not reached the stage of joint replacement, may find it worth discussing.

Treatment is generally not appropriate where there is infection at the treatment site, active malignancy, serious blood or clotting disorders, or during pregnancy or breastfeeding.

Final suitability, however, is determined by a physician after examination and imaging. It cannot be established from an article.

Main risks and side effects

Treatment intervals and number of sessions

• •Autologous adipose-derived stem cell therapy: local injection at intervals of at least one month, generally once every two to three months; intravenous administration at a minimum interval of one month, generally every two to three months.
• •PRP therapy: approximately 90 minutes from blood draw to injection. The number of sessions is determined by the physician.

Costs (private-pay, all figures tax-inclusive)

Note: a first-visit fee of ¥3,300 and follow-up fee of ¥2,200 (tax included) apply in addition to the above.
Note: all treatments are private-pay and are not covered by Japanese public health insurance.

6. From arrival to treatment

1 | Online pre-consultation

Share your history, test results, and any imaging. We assess whether travelling is likely to be worthwhile before you book anything.

2 | Visa

Most patients travelling for consultation and treatment use a standard short-stay visa. Japan also operates a medical stay visa, available to foreign patients travelling for treatment and to those accompanying them.

According to the Ministry of Foreign Affairs (page updated 29 July 2024; this article reflects information as of July 2026):

Visa requirements are subject to change. Before applying, please confirm current details on the Ministry of Foreign Affairs medical stay visa page (https://www.mofa.go.jp/mofaj/toko/visa/medical/index.html) and with the Japanese embassy or consulate handling your application. Please note that our clinic is not a registered guarantor organisation and is not in a position to guarantee visa issuance.

3 | First visit

Examination, testing, explanation, and informed consent. First visit ¥3,300 / follow-up ¥2,200 (tax included).

4 | Treatment

Protocols using cultured stem cells require two separate appointments — collection and administration — with a culture period in between, so travel should be planned accordingly. Same-day preparations such as PRP are completed in a single visit.

5 | Follow-up

The Act on the Safety of Regenerative Medicine requires provision plans to specify how patients are followed up after treatment. We conduct post-treatment follow-up in line with our filed plans and submit annual activity reports to the government.

If symptoms requiring attention arise after you return home, please seek local medical care first. We can provide written documentation of the treatment given for your local physician’s reference.

7. Frequently asked questions

1. The iPS cell-derived exosomes used in this treatment are unapproved pharmaceuticals that have not received approval under the Pharmaceuticals and Medical Devices Act.
2. They are obtained through a domestic distribution route for medical institutions in Japan.
3. There is no approved domestic pharmaceutical with equivalent composition or performance.
4. They are not approved in major Western countries. Research is ongoing in several countries, and significant risks may not yet have been identified.
5. In the event of a serious adverse reaction, the national Relief System for Sufferers from Adverse Drug Reactions does not apply.

1. The umbilical cord-derived stem cell secretome used in this treatment is an unapproved pharmaceutical that has not received approval under the Pharmaceuticals and Medical Devices Act.
2. It is manufactured from umbilical cord blood sourced from healthy Japanese donors and obtained through a domestic distribution route for medical institutions in Japan.
3. There is no approved domestic pharmaceutical with equivalent composition or performance.
4. It is not approved in major Western countries, and significant risks may not yet have been identified.
5. In the event of a serious adverse reaction, the national Relief System for Sufferers from Adverse Drug Reactions does not apply.

All treatments described above are private-pay and are not covered by public health insurance. Individual results vary.

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