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Stem Cell Therapy in Japan: What the Law Covers and How to Check a Clinic

Stem cell treatment at Japan's private clinics is legal, regulated and self-pay, but not approved as effective. What the law requires; checking a clinic.

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Living Desk
6 min read
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Stem Cell Therapy in Japan: What the Law Covers and How to Check a Clinic

Japan lets private clinics offer stem cell treatment, mostly for knee and joint pain, and many advertise to visitors from abroad. It's legal and it's regulated. But the rules control how the treatment is delivered, not whether it works, and you pay the full cost yourself.

This page explains what the law does and doesn't cover, and how to check a clinic. It is not medical advice. Talk to your own doctor before deciding.

What the law covers

Since November 2014, the Act on the Safety of Regenerative Medicine has governed cell-based treatment at clinics. It sorts treatments into three classes by risk:

  • Class I: the highest risk, such as treatments using ES or iPS cells.
  • Class II: medium risk, such as treatments using your own adult stem cells, including stem cells taken from fat.
  • Class III: lower risk, such as processed non-stem cells.

Before offering a treatment, a clinic has to submit a treatment plan (teikyo keikaku) that has been reviewed by a certified committee; Class I plans also go to the health ministry. Registered plans are published on the government's e-Regenerative Medicine site.

What the law does not do is approve the treatment as effective. The Japanese Society for Regenerative Medicine has said plainly that self-pay stem cell treatment sits outside the framework where the state confirms a treatment works, that its safety and effectiveness haven't been confirmed by the government, and that it isn't covered by health insurance.

What Japan has actually approved

Two stem cell products have gone through Japan's approval process:

  • Temcell (2015): mesenchymal stem cells from donors, for acute graft-versus-host disease after a stem cell transplant.
  • Stemirac (December 2018): a patient's own bone-marrow stem cells, for spinal cord injury. It received a conditional and time-limited approval, a fast-track route that grants approval before full proof of effectiveness.

Neither is a treatment for knee arthritis, and claims that Japan "approved stem cells for knee osteoarthritis" are wrong. The approved regenerative product with a knee use is JACC, cartilage grown from the patient's own cells, first approved in 2012 for traumatic cartilage defects and extended in 2025 to some cases of knee osteoarthritis under strict conditions. More in regenerative medicine in Japan.

Culture supernatant and exosomes

Many clinics also sell injections or drips of stem-cell culture supernatant (the fluid the cells were grown in) or exosomes. These are not cells, and they fall outside the regenerative medicine law. In July 2024 the health ministry warned that no medicine of this kind has been approved with its safety and effectiveness shown.

How to check a clinic

  1. Ask which class the treatment is and for its plan number. Then find the plan yourself on the e-Regenerative Medicine site (saiseiiryo.mhlw.go.jp). If there's no plan, it isn't a registered cell-based treatment.
  2. Ask where your cells will be processed and who is responsible for that facility.
  3. Ask what evidence exists for your condition, and how the clinic tracks its own patients' outcomes.
  4. Get the full price in writing, including follow-up visits.
  5. Get a second opinion from an orthopaedic surgeon who doesn't sell the treatment.

Be wary of promises of cure, claims that one treatment fixes many unrelated conditions, and pressure to decide on the day.

Clinics compared

Listed in alphabetical order. We haven't been treated at these clinics, none of them paid to appear, and being listed isn't a recommendation. Details come from each clinic's own website, checked in October 2026. Prices aren't shown because most clinics quote them only after a consultation.

ClinicWhereTreatments on its websiteWorth knowingContact
Azabu Regenerative ClinicMinami-Azabu, TokyoPRP and Class II regenerative treatmentsPublishes its plan numbers on its site. Wednesday to Sunday, by reservation03-6277-4650
Clinique Haru Osaka-UmedaUmeda, OsakaYour own fat-derived stem cellsOrthopaedic clinic treating knees and shouldersclinique-haru-osaka.com
Hiza Kansetsu-sho Clinic11 branches from Sapporo to Fukuoka, including Ginza and ShinjukuPRP-FD, APS and cultured stem cells; also hyaluronic acid injectionsSpecialises in knees. Says on its site that these treatments aren't covered by insurance0120-013-712
Omotesando Helene ClinicOmotesando, TokyoYour own cultured mesenchymal stem cellsLists many uses beyond joints, including diabetes, arteriosclerosis, hair and skin. Interpreters in more than 14 languages03-3400-2277
Rakan Clinic TokyoAzabudai Hills, TokyoPRP, stem-cell culture supernatant, NK cell therapy, IV drips, acupunctureAlso a general orthopaedic clinicrakanclinic-tokyo.jp
Repair Cell ClinicTokyo (Takeshiba), Osaka (Fukushima), Sapporo; Fukuoka from November 2026, Nagoya from January 2027Your own fat-derived stem cells, PRPLists uses beyond joints, including stroke, spinal cord injury, diabetes and liver disease0120-706-313

Two of these clinics list conditions far beyond joints for the same stem cell treatment. Compare that with what Japan has actually approved, and ask any clinic for the plan number that covers your condition specifically.

For general English-speaking care in Tokyo, see English-speaking clinics in Tokyo. For PRP, see PRP therapy in Japan.

FAQ

Is stem cell therapy legal in Japan? Yes, when a clinic has registered a treatment plan under the 2014 law. Legal doesn't mean proven: the government hasn't confirmed these self-pay treatments work.

Is it covered by insurance? No. Japanese health insurance doesn't cover it. Check any travel or international policy before assuming it will pay.

Has Japan approved stem cells for knee arthritis? No. Japan's approved stem cell products are for graft-versus-host disease (Temcell) and spinal cord injury (Stemirac).

How do I check a clinic? Ask for the treatment plan number and look it up on the government's e-Regenerative Medicine site.

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Living Desk

The Standard Japan

Living in Japan: healthcare, banking, work, visas and settling into a city.

Facts are taken from primary sources (operators, venues, official tourism and government pages) and dates and prices are checked on the day of writing. Pages are revised when those sources change.

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Healthcare, banking, work culture, visas, relocation

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stem cell therapy japanregenerative medicineautologous stem cellsknee osteoarthritisjapan regenerative medicine law
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