Explanation of receiving Cell Donation and Regenerative Medicine
Name of regenerative medicine:
Treatment of autoimmune diseases using autologous adipose (tissue)-derived mesenchymal stem cells
This information document is intended to help you understand the details of regenerative medicine
donation correctly and to help you decide whether or not to donate cells and receive regenerative
medicine based on your will. Please read this instruction document carefully, listen to the explanationof your physician, and decide whether or not to undergo cell donation or regenerative medicine after
careful consideration. If you have any questions, please feel free to ask us any questions you may have.
1. Name of the regenerative medicine and notification to the Ministry of Health, Labour andWelfare
The name of this therapy is “Treatment of autoimmune diseases using autologous adipose (tissue)derived mesenchymal stem cells”. Based on the “Act on Safety Assurance of Regenerative Medicine”,
a “Plan for Provision of Regenerative Medicine” has been submitted to the Minister of Health, Labourand Welfare.
2. Information regarding medical institutions that receive cell donations, medical institutions
that provide regenerative medicine
Name of medical institution: Medical Corporation JK Medical Japan JK beauty & Cell Clinic
The administrator of the medical institution: SHIM JOONBO, President
Person in charge of regenerative medicine: SHIM JOONBO
Physician who collects cells: SHIM JOONBO
Physician providing regenerative medicine： SHIM JOONBO
3. Purpose and details of the use of the cells and regenerative medicine
The cells to be collected this time will be used for the “treatment of autoimmune diseases using
autologous adipose (tissue)-derived mesenchymal stem cells”. This treatment aims to improve thesymptoms of autoimmune diseases by utilizing the ability of autologous adipose-derived mesenchymal
stem cells to secrete immunosuppressive and anti-inflammatory factors. At first, the patient’s fat isextracted, and adipose-derived stem cells extracted from the fat are grown to the required number ofcells by culture. Once the number of cells has grown to a sufficient number, they are administeredintravenously (intravenous infusion). Since the patient’s blood is used to culture the cells, blood is
also collected along with the fat collection.
4. Reasons for being selected as a cell donor
Since this treatment uses cells collected from the person (you) who is to receive the regenerativemedicine, you have been selected as a cell donor.
(Selection criteria)
You must be the person who will receive the regenerative medicine.
(Exclusion criteria)
We do not set our exclusion criteria as a cell donor.

The criteria for recipients of regenerative medicine, etc. are as follows.
【Selection criteria】
Persons who meet all of the following criteria shall be eligible for this treatment.
・Patients who have been diagnosed with the following autoimmune diseases, whose main symptoms
have not improved with existing conservative therapies, and whose need for this regenerative medicine
is considered to be high.
(1) Patients with systemic scleroderma (systemic sclerosis)(2) Systemic lupus erythematosus(3) Atopic dermatitis(4) Autoimmune inner ear disease (AIED)(5) Multiple sclerosis (MSS)(6) Polymyositis(7) Rheumatoid arthritis(8) Crohn’s disease(9) Psoriasis vulgaris
・Patients aged 20 to 80 years*For patients over 80 years of age, the physician administering this treatment will determine whether or
not to provide treatment, taking into consideration the health and physical conditions of the person
receiving the treatment.
【Exclusion Criteria】
The following persons are excluded from this treatment.
・Those who have experienced hypersensitivity or allergic symptoms to anesthetics used in fat
harvesting or to substances used in the manufacturing process of specific cellular processed products.
・Those who have developed an infectious disease.
The physician who performs the treatment will make the final decision on whether or not to provide thetreatment.

5. Regarding cells used for regenerative medicine
Adipose tissue is collected at our clinic, and stem cells are cultured at a facility affiliated with ourclinic to increase the number of stem cells until they become the necessary cells, which are thenadministered intravenously.

6. Benefits (e.g., effects) and disadvantages (e.g., risks) of donating cells and receiving
regenerative medicine.
The following benefits and disadvantages are expected from the donation of cells and treatment.
The administration of adipose-derived stem cells is expected to improve the symptoms of autoimmune
diseases by suppressing attacks on the self by the immune system and the resulting inflammation
through the action of immunosuppressive factors and anti-inflammatory factors secreted from adiposederived stem cells. The risks associated with this treatment include complications and side effects that
may occur with fat harvesting and administration of the cells. In addition, although the causal
relationship is unknown, there have been cases in which patients who received intravenous infusion ofadipose-derived stem cells have died due to pulmonary embolism (a condition in which the bloodvessels in the lungs become clogged).
<About Albumin Products >Human serum albumin is added to the product to maintain cell activity and viability. This product isformulated from human blood, and at the time of collection of the raw material, a medical examinationand tests related to infectious diseases are conducted. In addition, certain inactivation and removal
processes are performed during the manufacturing process, and safety measures against infectious
diseases are taken. However, since viruses such as human parvovirus B19 and abnormal prions thatcause variant Creutzfeldt-Jakob disease cannot be eliminated, the possibility of their infection cannot
be ruled out. Although the frequency is unknown, shock and anaphylaxis may occur as serious adverse
reactions. Other side effects may include hypersensitivity (hypersensitivity to the drug) andanaphylaxis (anaphylaxis). Other possible side effects include hypersensitivity (fever, facial flushing,urticaria, etc.), chills, and back pain.
7. You may refuse to donate cells or undergo regenerative medicine
You will not be forced to donate cells or receive this treatment. After receiving an explanation, if you
decide that you should not receive cell donation or this treatment, you may refuse to donate cells or
receive this treatment at any time.
8. Withdrawal of Consent
You may withdraw your consent at any time, even if you have given your consent to donate cells or toreceive this treatment.
9. There is no disadvantageous treatment due to refusal or withdrawal of consent
You will not be disadvantaged in any way in your future medical care or treatment, even if you refuse
to receive the cell donation or this treatment after receiving an explanation or withdraw your consent
after having agreed to receive the cell donation or this treatment.
10. Protection of Personal Information
Personal information obtained in the course of treatment will be properly managed and protected, andwill not be disclosed outside the clinic. However, treatment results might be anonymized and used forpresentation and reporting to related academic societies to improve the effectiveness of treatment, andfor publication of the clinic’s treatment results.

11. Storage and disposal of cells and other materials
To investigate the cause of any disease suspected to be caused by this treatment, blood samples will befrozen and stored for 10 years, and a portion of cultured adipose-derived mesenchymal stem cells will
be frozen and stored for 30 years. After the storage period, the adipose-derived stem cells will bedisposed of as medical waste by contracting disposal to a contractor.
12. Attribution of Patent Rights, Copyrights, Other Property Rights, and Economic Benefits
Related to Regenerative Medicine
Any new patent rights, copyrights, other property rights, or economic benefits arising fromregenerative medicine using cells donated by you will belong to our hospital.
13. Complaint and Inquiry System
The clinic has established a contact for complaints and inquiries regarding this treatment method as
follows. After receiving a complaint or inquiry at the contact counter, it will be reported to the treating
physician and the administrator (hospital director) for handling.
Contact (department in charge: Administration Office)Phone number: +81 55-267-7378
14. Costs
When providing treatment, the patient will be asked to pay 2,200,000 yen (including tax)/treatment as
our prescribed fee, as this treatment is not covered by public insurance.
*The treatment fee may vary depending on the patient’s symptoms and other circumstances.
Please note that if a patient withdraws consent after the collection or processing of cells, or if any costs
have been incurred up to the time of withdrawal of consent, the patient will be responsible for any costs
incurred.
15. Availability of other treatment methods and comparison with this treatment method
One treatment for autoimmune diseases is to suppress the autoimmune response by suppressing theimmune system through the administration of medications. However, many of the medications used tocontrol autoimmune reactions also reduce the body’s ability to fight disease, especially infection. The
long-term use of medications that suppress the immune system (immunosuppressive drugs), such asazathioprine, chlorambucil, cyclophosphamide, cyclosporine, mycophenolic acid, and methotrexate,can be expected to reduce the symptoms of autoimmune diseases. However, these medications not only
suppress the autoimmune response, they also suppress the body’s ability to defend itself against foreignsubstances, including infection-causing microorganisms and cancer cells, thus increasing the risk ofdeveloping certain types of infections and cancers. In addition, because of the administration ofmedications, there is also the risk of side effects. The benefits of this treatment are that the patient’sadipose-derived stem cells are administered, so there is no risk of side effects, and there is less risk ofinfection or cancer development due to a weakened immune system compared to the administration ofmedications.

16. Compensation for health damage
In the event of any health problems that may be caused by the donation of cells or this treatment, pleasecontact us immediately so that we can take the necessary measures to the best of our ability.
17. Regarding information and matters to be examined by the Accredited Committee forRegenerative Medicine, which examines regenerative medicine
According to the “Act on Securing Safety of Regenerative Medicine,” regenerative medicine provisionplans must be reviewed by a “Certified Regenerative Medicine Committee” before submission to theMinister of Health, Labor, and Welfare. Our clinic has undergone the following review of theregenerative medicine provision plan for this treatment.
The Certified Committee for Regenerative Medicine, that conducted the review:
Vivian Specific Certified Committee for Regenerative Medicine
Contact for complaints and inquiries: 080-2740-2323.
Matters examined: A plan for the provision of regenerative medicine, and a set of attached materials aresubmitted for review in light of the “Standards for the Provision of Regenerative Medicine”, establishedby the “Act on Safety Assurance of Regenerative Medicine”.
18. Other important notes・After receiving this treatment, you will be asked to return to the clinic once every 30 days until 6months after the date of the treatment for periodic follow-up visits to verify the occurrence of healthproblems and the effectiveness of the treatment. In addition, we may ask you to visit the clinic at othertimes if necessary.
・The human genome and genetic analysis will not be performed in the course of this treatment.
・We will not use the cells collected during the treatment or the specific cellular products manufactured
during the treatment for any other treatment or research in the future.

Consent Form
Medical Corporation JK Medical Japan JK beauty & Cell Clinic
To: Dr. SHIM JOONBO, President
I have received the following explanation regarding the donation of cells for regenerative medicine,etc. (name: “Treatment of autoimmune diseases using autologous fat (tissue)-derived mesenchymal
stem cells”).
□ Name of regenerative medicine and notification to the Ministry of Health, Labour, and Welfare.
□ Information about the medical institution to which the cells will be donated.
□ Usage of the cells.
□ Reason for being selected as a cell donor.
□ Benefits (e.g., effects) and disadvantages (e.g., risks) of cell donation.
□ Rights to refuse the cell donation.
□ Withdrawal of consent.
□ Rejection of cell donation or withdrawal of consent will not cause any disadvantageous treatment.
□ Protection of Personal Information.
□ Regarding storage and disposal of cells and other materials.
□ Regarding patent rights, copyrights, other property rights, and economic benefits related toregenerative medicine.
□ Complaint and inquiry system.
□ Regarding the cost.
□ About compensation for damage to health.
□ Information and other matters to be examined by the Accredited Committee for RegenerativeMedicine, which examines regenerative medicine.
□ Other important notes.
I have received the following explanation regarding the provision of regenerative medicine (name:“Treatment of autoimmune diseases using autologous fat (tissue)-derived mesenchymal stem cells”).
□ Name of regenerative medicine and notification to the Ministry of Health, Labour, and Welfare.
□ Information on the medical institution providing regenerative medicine.
□ Purpose and details of the regenerative medicine.
□ Cells to be used for regenerative medicine.
□ Benefits (e.g., effects) and disadvantages (e.g., risks) of receiving regenerative medicine.
□ The right to refuse to receive regenerative medicine.
□ Withdrawal of consent.
□ The fact that no one will be treated disadvantageously by refusing to receive regenerative medical
treatment, or withdrawing consent.
□ Protection of Personal Information.
□ Storage and disposal of cells and other materials.
□ Complaint and inquiry system.
□ Regarding the cost of the treatment.
□ Availability of other treatment methods and comparison with this treatment method.
□ About compensation for damage to health.
□ Information and matters to be reviewed by the Accredited Committee for Regenerative Medicine,which examines regenerative medicine.
□ Other important notes.

I have explained the above information to the patient.

Date of explanation

The doctor in charge of the explanation

I fully understand the above explanation and agree to receive the donation of cells and regenerative
medicine. I confirm that I can withdraw this consent at any time before the start of cell processing ortreatment.

Date of Consent

Patient’s Signature

Signature of the legal representative(Relationship with the patient)Consent Withdrawal Form

Medical Corporation JK Medical Japan JK beauty & Cell Clinic
To: Dr. SHIM JOONBO, President
I hereby withdraw my consent to the donation of cells for regenerative medicine (treatment ofautoimmune diseases using autologous adipose (tissue)-derived mesenchymal stem cells).
I have no objection to bearing the costs of treatment and other expenses incurred before I withdraw
my consent.

Date of withdrawal

Patient’s Signature

Signature of the legal representative（Relationship with the patient）Consent Withdrawal Form

Medical Corporation JK Medical Japan JK beauty & Cell Clinic
To: Dr. SHIM JOONBO, President
I hereby withdraw my consent to receive regenerative medicine, etc. (name: “Treatment ofautoimmune diseases using autologous adipose (tissue)-derived mesenchymal stem cells”).
I have no objection to bearing the cost of treatment and other expenses incurred before I withdraw myconsent.

Date of withdrawal

Patient’s Signature

Signature of the legal representative（Relationship with the patient）