COMPLIANCE
Legal compliance

Umbilical cord stem cell-derived exosome liquid "Prosentan"

(1) Treatment Details: Stem cell-derived exosomes are administered to patients via inhalation, topical application, subcutaneous injection, intravenous injection, or intramuscular injection, with the aim of achieving various effects.
(2) Prescription Drugs and Fees: Stem cell-conditioned culture medium (10 bottles per box, 280,000 yen).
(3) Main Side Effects and Risks: Minor symptoms such as itching, rash, slight fever, and allergic reactions may occur in rare cases.
(4) Disclosure of Unapproved Drug: This drug is not approved in Japan and is prescribed on a private basis.
*Unapproved drugs are not covered by public relief systems (Drug Adverse Reaction Relief System, Biological Product Infection Relief System).
Please note.
(5) Disclosure of Source of Acquisition: This drug is formulated in-house.
(6) Availability of domestically approved drugs with the same ingredients and efficacy: No.
(7) Disclosure of Safety Information in Other Countries: Based on the safety standards for exosome therapy. No major adverse events have been reported.

Stem cell administration treatment (intravenous administration/subcutaneous)

(1) Treatment Details: Autologous stem cells are cultured in our in-house CPC and administered intravenously, subcutaneously, intramuscularly, or intra-articularly to patients with tissue regeneration.
(2) Prescribed Drugs and Fees: Stem cells (fees vary depending on the number of cells).
(3) Main Side Effects and Risks: Minor symptoms such as itching, rash, slight fever, and allergic reactions may occur in rare cases.
(4) Disclosure of Unapproved Drug: This treatment is an unapproved drug in Japan and is prescribed at a private expense.
*Unapproved drugs are not covered by public relief systems (Drug Adverse Reaction Relief System, Biological Product Infection Relief System).
Please note.
(5) Disclosure of Source: This drug is manufactured in our in-house CPC.
(6) Availability of domestically approved drugs with the same ingredients and efficacy: No.
(7) Disclosure of Safety Information in Other Countries: Based on safety standards for stem cell therapy. No major adverse events have been reported.

Stem cell administration treatment (intra-articular)

(1) Treatment Details: Autologous stem cells are cultured in our in-house CPC and administered to the patient via intra-articular injection or other methods, with the hope of regenerating tissue within the joint.
(2) Prescribed Drugs and Fees: Stem cells (fees vary depending on the number of cells).
(3) Main Side Effects and Risks: Minor symptoms such as itching, rash, slight fever, and allergic reactions may occur in rare cases.
(4) Disclosure of Unapproved Drug: This treatment is an unapproved drug in Japan and is prescribed at a private expense.
*Unapproved drugs are not covered by public relief systems (Drug Adverse Reaction Relief System, Biological Product Infection Relief System).
Please note.
(5) Disclosure of Source: This drug is manufactured in our in-house CPC.
(6) Availability of domestically approved drugs with the same ingredients and efficacy: No.
(7) Disclosure of Safety Information in Other Countries: Based on safety standards for stem cell therapy. No major adverse events have been reported.

Stem cell administration treatment (periodontal disease)

(1) Treatment Details: Autologous stem cells are cultured in our in-house CPC and administered to patients via methods such as gingival injections, with the hope of regenerating surrounding tissue.
(2) Prescribed Drugs and Fees: Stem cells (fees vary depending on the number of cells).
(3) Main Side Effects and Risks: Minor symptoms such as itching, rash, slight fever, and allergic reactions may occur in rare cases.
(4) Disclosure of Unapproved Drug: This treatment is an unapproved drug in Japan and is prescribed at a private expense.
*Unapproved drugs are not covered by public relief systems (Drug Adverse Reaction Relief System, Biological Product Infection Relief System).
Please note.
(5) Disclosure of Source: This drug is manufactured in our in-house CPC.
(6) Availability of domestically approved drugs with the same ingredients and efficacy: No.
(7) Disclosure of Safety Information in Other Countries: Based on safety standards for stem cell therapy. No major adverse events have been reported.

About medical advertising guidelines

In response to the medical advertising guidelines that came into effect on June 1, 2018, the HELENE Group has removed testimonials from its website. We have also completely revised our website so that when case photos are posted, an explanation of the procedure, the risks involved, and the cost of the procedure are also displayed. We
apologize for any inconvenience this may cause to our patients and customers, and we appreciate your understanding.

Partial excerpt from the original medical advertising guidelines

Part 1 Purpose of Advertising Regulations

Partial revision of the Medical Care Act

As with other advertising media, limiting the items that can be advertised on the websites of medical institutions, etc. may hinder the smooth provision of information requested by patients, such as detailed medical treatment content. Under certain conditions, restrictions on items that can be advertised will be lifted.

Section 3 Prohibited Advertisements

(5) Testimonials regarding the contents or effects of treatments, etc., based on subjective opinions of patients, etc.

Article 1-9, Item 1 of the Ministerial Ordinance stipulates that "not to advertise patient's or other person's subjective experiences or testimonials based on hearsay." Refers to subjective testimonials based on one's own experiences or hearsay from family members, etc., for the purpose of attracting patients to the medical institution concerned. The impression will naturally differ depending on the person, and it is not acceptable as an advertisement related to medical care, given that there is a risk of misleading.

(6) Photographs, etc. before or after treatment, etc. that may mislead the patient, etc. as to the content or effect of the treatment, etc.

Article 1-9, Item 2 of the Ministerial Ordinance stipulates that “not to advertise before or after treatment, etc. that may mislead patients, etc. about the content or effect of treatment, etc.” This refers to so-called before-after photographs, etc. However, given that the results of treatment, etc., naturally differ depending on the conditions of individual patients, photographs, etc. that may mislead patients are not permitted as medical advertisements. be something that cannot be

This does not apply to cases where detailed explanations of matters normally required for treatment, costs, etc., or matters concerning the main risks and side effects of treatment, etc. are attached to pre- or post-operative photographs. Furthermore,
sufficient consideration must be given to the location of such information so that it is easy for patients, etc., to understand, and for example, formats such as posting it on a linked page or posting it in extremely small letters compared to information about benefits and advantages must not be adopted.

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Former Health, Labor and Welfare Minister Ritsuo Hosokawa
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