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Medical institutions performing ANK therapy
Due to the enforcement of the Act on Securement of Safety of Regenerative Medicine, medical institutions that perform ANK therapy are required to be registered at the administrative authorities in charge.
Because the registration is performed for each treatment method, ANK therapy cannot be received except at a medical institution that is registered as "ANK therapy is performing clinic."
For the convenience of patients, the following is a summary of the recommended opinions of the Cancer Cell Immunotherapy Review Committee, a certified regenerative medicine committee.

If you have any questions, please contact the ANK Information Center.

① Interview with doctor

Please have your interview with a doctor at a registered ANK therapy medical institution.
The treatment design varies according to each of the patients, depending on the patient’s condition, so the doctor will carefully listen and understand the patient’s situation. ANK therapy is costly so it is important that the patient understands the details of the treatment and considers thoroughly whether to receive the treatment.

② Collect lymphocytes

The actual treatment will start after the patient submits the consent form and pays the treatment cost. First, lymphocytes containing NK cells will be collected from the patient’s blood. This lymphocyte collection will be done at a medical institution with a dedicated device that separates and collects lymphocytes from blood equivalent to 5 – 8 liters, in principle, of blood. The collection will take three to four hours.

③ Culture NK cells

Collected lymphocytes will be brought to the culture center in Kyoto on the day of the extraction*. The culture duration is 3 weeks for lymphocyte amounts equivalent to 1 course treatment, and can vary from 2 to 4 weeks depending on the treatment plan. During this culturing period, the culture center will selectively proliferate only the NK cells up to numbers within the predetermined range and increase the NK cell activity to the level above the standard.

*Patients or families can carry the collected lymphocytes to the culture center in Kyoto, but delivery is usually entrusted to a specialist.

④ Return cultured NK cells to the patient’s body

Cultured NK cells (ANK cells) are delivered to the designated treatment-performing medical institution. In principle, ANK cells are returned to the body through 12 infusions (1 course), 2 infusions a week. The time required for the infusion is about 30 minutes to 1 hour each time. Both the lymphocyte collection and the infusion treatments basically do not require hospitalization and are done on visits.

⑤ Known symptoms when returning ANK cells to the patient’s body

There are patients who show severe chills after ANK cells infusion. Also, fever is known to always occur after infusion; to be precise, patients who gets fevers up to 40 Celsius are not that rare. Especially, the first and second infusion will most likely cause fever as well as joint pain and nausea as if the patient is suffering from a bad cold, but without sore throat and cough. Some people may also feel a tingling pain where the tumor is located. Fever is a typical symptom caused by immunostimulants such as interferons when released in large numbers by ANK cells.

Since immunostimulants always cause fever, it is important to overcome them with ingenuity even if it is difficult. Antipyretics have the effect of suppressing immunity strength, so if the patient is willing to take them, by all means it is necessary that the patient seeks consultation from the doctor beforehand.

Chills are caused when immunostimulants expand the blood vessels, suddenly releasing heat. Pain where the tumor is located is caused by inflammation due to the fight between ANK cells and cancer cells. It is also common for complications to ease after repeated ANK cells infusions. Some patients reported positive side effects such as their taste and appetite returning, body pains easing, better sleep, smoother skin, and more.

⑥ When received in combination with standard treatment

When used in combination with standard treatment, the ideal flow is to collect lymphocytes before receiving standard treatment, and then receive ANK cells infusion treatment after.
The sooner the lymphocytes are collected the better, even if you have already started standard treatment. Standard treatment is good at reducing the number of cancer cells drastically, but if the surviving cancer cells go berserk, causing recurrent or metastasis, there will be no further options.
However, ANK therapy is good at eliminating small cancers, but the numbers and costs of the treatment increase when the cancer is large.
Therefore, when used in combination with standard treatment, considering cost-effectiveness, it is best to collect lymphocytes before the immune cells are damaged by standard treatment, culture them, preserve the cultured cells with cryopreservation, and deliver a final blow to the cancer cells after the standard treatment, once the number of cancer cells have decreased.
In the case of anti-cancer drugs, cancers can become resistant to the drugs by repeated administration, and at a certain stage the drug’s effects disappear. Resistance does not appear in ANK therapy in this manner. Aside from the cost issue, there is no limit to how many times the patient can receive the treatment.

⑦ Simultaneous combination with biologicals (molecular targeted drugs) is often performed

Biological drugs can be expected to synergistically support NK cells, depending on the nature of cancer cells, so their simultaneous combination with ANK therapy is recommended. On a side note, typical high toxic anti-cancer drugs such as chemotherapy drugs (cell killing anti-cancer drugs) cannot be simultaneously used together with ANK therapy. As described in ⑥, ideally, lymphocytes are first collected and cultured before high toxic anti-cancer drugs are administered, and ANK therapy along with molecular targeted drug therapy are received after the cancer cells have decreased. Hormonal therapy drugs used for prostate cancer and breast cancer do not damage immune cells, so these are recommended as well for simultaneous combination.

On the other hand, the immune-stimulating drugs and Chinese medicine will not be effective enough for patients who have strong immunosuppression. Some immune-stimulating drugs cause fever, but ANK therapy itself causes fever as well, so they are not recommended for combination.
Moreover, Chinese medicine must be administered carefully since many of them have unexpected immunosuppressive effects.

After ANK therapy is over, there are cases in which patients take other immunostimulants or very specific Chinese medicines for the purpose of not lowering or raising the immunity that has been restored to some extent.

⑧ Interaction between ANK therapy and antibody drugs (biologicals)

Trastuzumab (trade name: Herceptin) is an antibody drug that suppresses cancer with a completely different mechanism from the conventional chemotherapeutic agents. It binds to the numerous targets on the surface of cancer cells and has the effect of suppressing the growth of cancer.
However, Trastuzumab does not have the ability to kill cancer cells. On the other hand, NK cells have the ability to bind to some of the antibodies, and when they bind with Trastuzumab, they are strongly stimulated to kill cancer cells. This is called ADCC activity (antibody-dependent cytotoxic activity).
Therefore, the interaction between Trastuzumab and NK cells can be expected to increase cytotoxic activity. Whether or not Trastuzumab can be administered requires pre-examination, and not everyone can receive them.

The graph to the left shows the cytotoxic activity of immune cells from each culturing method, under the same condition with strong HER2 positive cells (breast cancer cells) added. Since the ordinal methods do not show positive interactions with antibodies, the ADCC activity is low.

⑨ The importance of designing cancer treatment plan at earliest after diagnose

Since the condition of each cancer patient is different, the treatment plan should be completely tailored. When cancer is diagnosed, it is important to first get an accurate diagnosis at a large and trusted hospital and listen carefully to the doctor’s explanation of the standard treatment plan. If the patient is interested in ANK therapy, the patient may want to also consult to an ANK therapy-performing doctor and listen carefully to the doctor’s suggested treatment plan.

The sooner the patient acts, the more treatment options will be available to the patient. The idea of moving on to a different treatment after the previous treatment fails will only narrow the treatment choices which the patient can receive.
The available treatment options for combination with ANK therapy may change depending on whether it is performed before or after surgery. Receiving consultation from an ANK therapy-performing doctor does not mean the patient will have to receive ANK therapy.

Therefore, if the patient is unsure whether to receive ANK therapy, it is recommended that the patient seek consultation with an ANK therapy-performing doctor as soon as possible. We ask the patient to understand that the first course of action or treatment plan is essential, and it will affect the treatment outcome significantly.