COMPLIANCE Compliance with Laws and Regulations

Stem cell therapy (intravenous administration/subcutaneous administration)

1. Treatment details: Autologous stem cells are cultured at Helene in-house lab (CPC) and administered to the patient through intravenous(IV), subcutaneous, intramuscular, or intra-articular methods, with the expectation of tissue regeneration.
2. Prescription-available medications and fees: Stem cells (fees vary depending on the number of cells)
3. Regarding the main side effects and risks: Mild symptoms such as itching, rash, low-grade fever, and allergic reactions may rarely occur.
4. Important Notice Regarding Unapproved Therapies: This treatment utilizes therapeutic agents that are currently not approved under standard Japanese regulatory frameworks, and is administered exclusively on a private, self-pay basis.
   ※Public statutory relief systems—specifically the PMDA's Adverse Drug Reaction Relief System and the Relief System for Infections Acquired through Biological Products—do not apply to therapies utilizing unapproved medical products. We kindly ask for your understanding prior to initiating treatment.
5. Sourcing and Production Transparency: This pharmacy product is custom-prepared at Helene in-house lab (CPC).
6. Availability of Approved Alternatives in Japan: There are currently no approved domestic pharmaceuticals with identical ingredients or therapeutic efficacy.
7. Safety Information and Clinical Data from Other Jurisdictions: The safety profile of this treatment aligns with established clinical standards for exosome therapies. To date, no major adverse events have been reported globally.

Stem cell therapy (intra-articular)

1. Treatment details: Autologous stem cells are cultured at Helene in-house lab (CPC) and administered to the patient through intra-articular methods, with the expectation of tissue regeneration.
2. Prescription-available medications and fees: Stem cells (fees vary depending on the number of cells)
3. Regarding the main side effects and risks: Mild symptoms such as itching, rash, low-grade fever, and allergic reactions may rarely occur.
4. Important Notice Regarding Unapproved Therapies: This treatment utilizes therapeutic agents that are currently not approved under standard Japanese regulatory frameworks, and is administered exclusively on a private, self-pay basis.
   ※Public statutory relief systems—specifically the PMDA's Adverse Drug Reaction Relief System and the Relief System for Infections Acquired through Biological Products—do not apply to therapies utilizing unapproved medical products. We kindly ask for your understanding prior to initiating treatment.
5. Sourcing and Production Transparency: This pharmacy product is custom-prepared at Helene in-house lab (CPC).
6. Availability of Approved Alternatives in Japan: There are currently no approved domestic pharmaceuticals with identical ingredients or therapeutic efficacy.
7. Safety Information and Clinical Data from Other Jurisdictions: The safety profile of this treatment aligns with established clinical standards for exosome therapies. To date, no major adverse events have been reported globally.

Stem cell therapy (for periodontal disease)

1. Treatment details: Autologous stem cells are cultured at Helene in-house lab (CPC) and administered to the patient through gingival injection methods, with the expectation of promoting regeneration in the surrounding tissues.
2. Prescription-available medications and fees: Stem cells (fees vary depending on the number of cells)
3. Regarding the main side effects and risks: Mild symptoms such as itching, rash, low-grade fever, and allergic reactions may rarely occur.
4. Important Notice Regarding Unapproved Therapies: This treatment utilizes therapeutic agents that are currently not approved under standard Japanese regulatory frameworks, and is administered exclusively on a private, self-pay basis.
5. Public statutory relief systems—specifically the PMDA's Adverse Drug Reaction Relief System and the Relief System for Infections Acquired through Biological Products—do not apply to unapproved medical products. We kindly ask for your understanding prior to initiating treatment.
6. Sourcing and Production Transparency: This pharmacy product is custom-prepared at Helene in-house lab (CPC).
7. Availability of Approved Alternatives in Japan: There are currently no approved domestic pharmaceuticals with identical ingredients or therapeutic efficacy.
8. Safety Information and Clinical Data from Other Jurisdictions: The safety profile of this treatment aligns with established clinical standards for exosome therapies. To date, no major adverse events have been reported globally.

Compliance with Medical Advertising Guidelines

Following the implementation of the new medical advertising guidelines on June 1, 2018, the HELENE Group has removed testimonials from its website.
Furthermore, we have completely revised our website to include explanations of the procedure, its risks, and its price whenever we post case photos.
We apologize for any inconvenience or disruption caused to our patients and customers viewing this website, and we appreciate your understanding.

What are medical advertising guidelines?

These are guidelines issued by the Ministry of Health, Labour and Welfare regarding advertising by medical institutions.
These guidelines aim to ensure the accurate and objective transmission of information.

Our Core Commitments

We do not use discount campaigns or other methods to attract customers.

We strictly refrain from utilizing aggressive marketing promotions or excessive discounting that could compromise a patient’s independent, objective judgment.
Our clinical philosophy dictates that every patient must be fully informed, comprehensively understand the parameters of the therapy, and provide wholehearted consent prior to proceeding with any treatment.

The main side effects and risks are clearly stated.

To empower patients to make fully informed, carefully considered decisions, we provide a balanced, transparent overview that details both the therapeutic benefits and any associated risks or potential adverse reactions.
This transparency extends to our clinical consultations, where our specialized physicians deliver comprehensive, meticulous briefings to address every aspect of your care.

All clinical case studies and before-and-after photographs are presented entirely unaltered, without any form of digital editing, manipulation, or enhancement.

We strictly prohibit the use of altered or digitally enhanced imagery that could cause a misleading impression or misrepresent actual clinical efficacy.

Transparency in Our Clinical Protocol

To ensure patients remain thoroughly informed at every stage, we provide an explicit, step-by-step roadmap outlining the entire continuum of care up to the completion of the procedure.
This transparency is mirrored in our clinical consultations, where our medical team delivers meticulous explanations, addressing every detail until you achieve absolute clarity and peace of mind.

Official Excerpts from the Medical Advertising Guidelines

Legal Disclaimer: Specified Commercial Transactions Act