HITV Therapy|東京のがん免疫療法なら【ICVS東京クリニック】まで

HITV
Therapy

HITV Therapy
- Human Initiated Therapeutic Vaccine -


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ICVS Tokyo Clinic welcomes patients from overseas.
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Please read : IMPORTANT INFORMATION about HITV therapy and our Clinic.

All medical services at ICVS Tokyo Clinic are by appointment only.


Conditions for HITV Therapy
HITV therapy is indicated for patients with recurrent cancer or advanced cancer diagnosed as stage IV. However, patients with early-stage cancer and those who wish to prevent recurrence, are also welcome to consult with us.
Detailed indications for individual patient like you or your loved one will be explained during the preliminary diagnosis

Who is Eligible for HITV Therapy?
Please consult with the doctor who performs this therapy (doctor who performs regenerative medicine, etc.) at ICVS Tokyo Clinic to determine whether you are eligible for the treatment.

The basic conditions for indication are as follows:
・ Advanced cancer such as recurrent cancer or stage IV, and solid cancer.
・ No diagnosis of dissemination (pleural or peritoneal dissemination, etc.)
・ For patients who have not had chemotherapy (anticancer drugs) and radiotherapy (if the tumor is sensitive to chemotherapy and radiotherapy), the number of tumors (metastases) should not exceed 20 and the maximum tumor diameter should not exceed 3 cm.
・ If the tumor is resistant to either chemotherapy (anticancer drugs) or radiotherapy (if the tumor is sensitive to radiotherapy or chemotherapy), the number of tumors (metastases) should not exceed 5 and the maximum tumor diameter should not exceed 3 cm.

Even if the above conditions are NOT met, a certain level of therapeutic effect may be expected.

At present, the basic conditions that do NOT apply to the therapy are:
・ The tumor has become resistant to both chemotherapy and radiotherapy.
・ In principle, elderly people aged 90 years or older, and children under 10 years of age.
・ Patients with significant impairment in ADL (activities of daily living) (e.g., bedridden, unable to eat).
・ Patient who is unable to express own will.

The doctor in charge will be decided by the Clinic on the day of your appointment.

ICVS Tokyo Clinic  Human Initiated Therapeutic Vaccine

 Leading You to a Cure For Cancer
 Treatment Flow & Achievements

Overview of HITV Therapy

HITV therapy (Human Initiated Therapeutic Vaccine) is an immunotherapy specialized for advanced cancers such as stage IV and recurrent cancer. This therapy maximizes the capabilities of Dendritic Cells, the command center of the immune system, and achieves much higher response rate compared to conventional methods by locally acting immunotherapy, which is normally classified as a systemic therapy*1. This therapy has almost no side effects and has led to the cure of many patients.

Dendritic Cells

Dendritic Cells are immune cells named in 1973 by the late Professor Ralph Marvin Steinman (1943-2011) of Rockefeller University in the United States. In the 1990s, it was discovered that Dendritic Cells play a central role in the immune system, recognizing foreign substances that enter the body and transmitting that information to T cells, which are responsible for immune attack.

Professor Steiman's award of the Nobel Prize in Physiology or Medicine in 2011 also served as a catalyst for the spread of cancer treatment using Dendritic Cells.

History of HITV Therapy

HITV Therapy began in 1996 when its inventor, Dr. Kenichiro Hasumi (Chairman of the Hasumi International Research Foundation), used Dendritic Cells to bring malignant lymphoma into remission. Subsequently, to further advance research on Dendritic Cells, Dr. Hasumi began collaborative research with University of Maryland in the United States. This basic research is continuing to date. HITV therapy has made rapid progress since a case in 2005 when a case of head and neck cancer was cured by injecting Dendritic Cells directly into the tumor was reported. After that, Dr. Hasumi established a treatment method called "combination of radiation therapy and intratumoral administration of Dendritic Cells" and "combination of chemotherapy and intraarterial administration of Dendritic Cells," which have proven effective in treating many cancer patients. In 2011, Dr. Hasumi began intratumoral administration of CTL (killer T cells), further improving the therapeutic effect of HITV therapy.

Since 2021, Dr. Hasumi has introduced a treatment method of Dendritic Cell administration alone without radiation therapy or chemotherapy, which has been steadily achieving results.

*1 Systemic therapy: Treatment performed on the whole body, such as anticancer drugs and hormone therapy. Local therapy refers to treatments such as surgery or radiation that limit the treatment area. HITV therapy greatly improves the therapeutic effect by locally acting on immunotherapy, which is originally a systemic therapy. The feature of HITV therapy is that Dendritic Cells are directly administered into tumors. By having Dendritic Cells learn practical cancer information, they induce immune cells that attack cancer cells effectively. This will be explained in the next page.

Mechanisms Leading to Cure of Cancer

What distinguishes HITV Therapy from other Dendritic Cell therapies is the "intratumoral administration" of Dendritic Cells (DCs), which our doctors administer DCs directly into the tumor. The mechanism is explained below.

HITV therapy efficiently teaches immune cells "live" cancer information.

Dendritic Cells are the key to the immune system, responsible for transmitting information about cancer cells as enemy to immune cells in charge of attacking. In other words, if Dendritic Cells can transmit more detailed information about the target cancer cells to those immune cells, the accuracy of cancer attack will be further improved. Therefore making Dendritic Cells learn the latest cancer information is important for the success of immunotherapy. HITV therapy teaches immune cells "live cancer information" by directly administering Dendritic Cells into the tumor. This method makes it possible to efficiently induce CTLs (killer T cells), the immune cells in charge of attacking cancer cells that act most specifically on cancer cells.

This intratumoral administration procedure has been performed more than 10,000 times, and is now capable of treating tumors anywhere in the body (except for brain tumors). While other institutions may have used intratumor delivery of Dendritic Cells, most have been limited to superficial tumors or sites close to the skin. Intratumor delivery without site-specific administration is rare, even worldwide.

Shrinking and Eradicating Tumors

HITV therapy is expected to have the following four effects, which work synergistically to reduce or eliminate cancer tumors.

Suppression of Tumor Inflammation

The biggest challenge in cancer immunotherapy is the inflammation that occurs during treatment. When dendritic cells are administered alone into a tumor, a strong immune response is generated, but the tumor becomes more susceptible to inflammation, so special care is required. If inflammation occurs in the tumor, the symptoms may accelerate rapidly and the tumor may become irreversible. It is known that inflammatory cytokines*2 are involved in tumor inflammation. HITV therapy can suppress the onset of inflammation by administering inflammatory cytokine antibody drugs together with Dendritic Cells.

*2 Inflammatory cytokines: Cytokines that cause various inflammatory symptoms in the body. Cytokines are proteins mainly secreted by immune system cells.

Tumor Vaccination

CTLs (killer T cells) are the main immune cells that attack cancer cells. By administering Dendritic Cells into the tumor, these Dendritic Cells can learn live cancer information and vaccinate the tumor. After that, the Dendritic Cells mature in the tumor or lymph nodes, and CTLs (killer T cells) are induced in about two weeks.

Blood Purification

In the case of recurrent cancer or advanced cancer with stage IV multiple organ metastasis, cancer cells overflow into the blood. Even if the tumor is treated with surgery or radiation therapy, if these cancer cells in the blood are not removed, recurrent metastasis will occur.

Chemotherapy and immunotherapy are effective in removing cancer cells from the blood. However, chemotherapy damages not only cancer cells but also normal cells, so side effects are a major problem. In HITV therapy, CTLs (killer T cells) that act specifically on cancer cells are produced by "vaccinating tumors" and are released into the blood. These CTLs travel through the body in the bloodstream, finding and eliminating cancer cells. The blood purification effect of HITV therapy is the key to preventing recurrence and metastasis.

High Antitumor EffectHITV-induced CTL Therapy

The CTLs (killer T cells) induced in peripheral blood by HITV therapy recognize highly antigenic cancer information, so a strong antitumor effect can be expected. In cases of multiple organ metastasis, or if new lesions or areas where the treatment is incomplete are discovered after treatment, these CTLs (killer T cells) can be collected from the blood, cultured, and massproduced, and then administered directly to the lesion, leading to tumor shrinkage. CTL therapy can be described as a versatile treatment that not only provides "systemic control" by producing CTLs in the body and purifying the blood, but also provides "local control" by administering them intratumorally.

Treatment Steps

HITV therapy consist of the following seven steps. The initial treatment plan is very important. The patient should discuss the treatment plan thoroughly with the physician and agree on the treatment method, duration, and cost before proceeding with HITV therapy.

Initial Consultation: Understanding the Treatment Plan

After reviewing the course of treatment prior to receiving HITV therapy and laboratory data such as PET-CT, ICVS Tokyo Clinic physicians will assess your current general condition and develop a treatment plan that is most appropriate for you.

Apheresis: Blood Component Separation Method

Apheresis is a procedure in which blood is centrifuged to extract specific blood cells and plasma. It takes 2 to 3 hours to extract mononuclear cells (the source of dendritic cells and activated T cells) and plasma (source of cell culture). Specifically, blood is collected from a vein in one of the upper limbs and then centrifuged within a circulatory circuit. After the necessary mononuclear cells and plasma are extracted, other blood components are returned to the body through the veins of the other upper limb. For this reason, it is necessary to have a relatively large blood vessel. If the veins in the patient's arms have become narrowed due to the use of anticancer drugs, etc., veins or arteries from other parts of the body may be used.

Biopsy: Analysis of inflammatory cytokine expression

Inflammation of the tumor may occur as a rapid immune response to intratumoral administration of Dendritic Cells. Inflammation of the tumor promotes transformation of the cancer cells and increases their proliferative potential, making the suppression of inflammation a critical process in the intratumoral administration of Dendritic Cells.

At ICVS Tokyo Clinic, we know through many clinical experiences that certain cytokines are involved in the inflammation process. Therefore, as an important response to HITV therapy, antibody drugs for inflammatory cytokines can be administered together with Dendritic Cells to suppress inflammatory complications.

As a pre-diagnosis for this purpose, a partial tissue sample (biopsy) is taken from the tumor and analyzed for expressed inflammatory cytokines to select the drugs to be used in the HITV treatment plan.

Cell Culture: Cultivation of Dendritic Cells and Activated T Cells

The components collected through apheresis are immediately transported to our group's CPC (Cell Processing Facility), where cultivation of Dendritic Cells and activated T cells begins. The cultivation period is generally about 4 weeks, although it depends on the condition of the collected components.

In our group, the following facilities have obtained official permission from the Ministry of Health, Labour and Welfare as specified cell processing facilities in accordance with the Regenerative Medicine Safety Ensuring Act.

ICVS Tokyo Clinic Cell Culture Room (Facility number FC3150408)
Medical Corporation Shukokai Hasumi Regenerative Medicine Research Institute Culture Department (Facility number FA3150018)
CELL Bio Lab (Facility number FA3220002)
ICVS Tokyo Clinic V2 Cell Culture Processing Facility (Facility number FC3200103)

Dendritic Cell Administration

Cultured Dendritic Cells are administered into the tumor (or into the major blood vessels feeding the tumor) together with an adjuvant called LCM (patented)*3 that enhances antigen recognition ability, with image confirmation by CT.
 In such cases, anti-inflammatory cytokine antibody drugs are used in combination as needed. The administered Dendritic Cells complete antigen recognition (learning information held by the cancer as a foreign substance) in approximately 24 hours.

*3 Adjuvant: An auxiliary agent that enhances the effect of the main ingredient. It plays a role in increasing the effectiveness of vaccines.

Activated T Cell Administration

After 24 to 48 hours from the administration of Dendritic Cells, "activated T cells" are administered intravenously through an intravenous infusion.

Activated T cells enhance the "killer activity" to eliminate cancer cells and immunologically memorize the functions of Dendritic Cells in the body. They are also called "memory cells."

Treatment Evaluation

The effectiveness of treatment is comprehensively determined based on data such as PET-CT image diagnosis and blood tests. Depending on the treatment plan, "CTL apheresis/CTL culture/CTL administration" may be performed after treatment evaluation.

Conditions for HITV Treatment

Indication for HITV Therapy depends on the patient’s prior treatment. If the patient is diagnosed as "applicable" for treatment, there is a greater chance of achieving a complete remission. The basic indications for HITV therapy are listed below.

Indications for HITV therapy

Chemotherapy and radiation therapy always come with the problem of "resistance." Resistance refers to the weakening of the effectiveness of a particular treatment when it is repeated.
As shown in the protocol (page 6), HITV therapy may be used in combination with standard treatment. If standard treatment is untreated, there are more protocols to choose from, and the range of treatment applications is accordingly wider.

preHITV Therapy to Prevent Cancer

Since Protocol C, which is administered after tumor disappearance, is also effective in preventing the development of new lesions, Protocol C has been applied separately from a series of treatment processes to prevent recurrence after surgery, and to cancer prevention programs for healthy individuals. It is now called preHITV Therapy (Preventive Human Initiated Therapeutic Vaccine).

Difference between HITV therapy and preHITV therapy

The initial difference between the two treatments, HITV and preHITV, is the site of administration. In the case of HITV therapy, intratumoral administration is performed to make Dendritic Cells learn cancer information. But as preHITV therapy aims at prevention, Dendritic Cells need to be distributed throughout the body. Therefore, we perform intra-arterial administration for this treatment. Arterial administration is usually done with a catheter, but at our Clinic, as with intra-tumor administration, it is injected percutaneously into the artery with CT confirmation. The major advantage of this procedure is that it causes less damage to the body and significantly reduces treatment and post-treatment rest time. The procedure, which generally requires hospitalization, can be performed as a day trip at our Clinic.

Treatment Duration (case sample)

For Patients who are healthy and want to prevent cancer;
Once every 3 months x 3
Once every 4 months x 3
Once every 6 months (continued)

For Patients in prevention of recurrence after disappearance of cancer in the body;
Once every month x 3
Once every 2 months x 3
Once every 3 months x 3
Once every 4 months x 3
Once every 6 months (continued)

Please note: Dosage intervals and administration site will be determined by the doctor depending on the patient's physical condition.

GREETING FROM DR. KENICHIRO HASUMI
Aiming to be a Beacon of Hope for Cancer Patients

With advances in medical technology, there are many cases where patients can return to society after being diagnosed with cancer. However, it is no exaggeration to say that lifeprolonging treatment is still the mainstream for stage IV and recurrent cancer. My motivation for developing and introducing HITV therapy was to save the lives of such patients with advanced cancer.

It has been almost 20 years since I began administering intratumoral Dendritic Cells. HITV therapy has evolved dramatically since then and is highly effective. Patients who are cured despite being diagnosed with cancer often receive "local treatment" such as surgery and radiation. In fact, there are almost no patients with solid tumors, except for hematologic cancers such as leukemia, who are cured by systemic treatment alone. Our HITV therapy has led "immunotherapy," which is basically a systemic therapy, to work locally.

Essential to HITV therapy is the skill to puncture precisely into the tumor. In principle, it is necessary to be able to puncture all sites (except the brain), since cancer does not choose the site of origin. We have developed this technique through numerous clinical experiences. And it is now possible to introduce Dendritic Cells into tumors regardless of the site.

However, when Dendritic Cells are injected into a tumor alone, the tumor itself may become inflamed, resulting in rapid cancer progression. To prevent this inflammation, radiotherapy and anticancer agents have been used until recently (Protocols A and B). One of the corrective points of this method was that the timing of cell administration was restricted, resulting in frequent administration. To resolve this issue, I developed a new treatment procedure incorporating an antibody drug for inflammation and named it Protocol D. With the advent of Protocol D, it became possible for us to vaccinate tumors without the restrictions of standard treatment. By simplifying the treatment, we were also able to reduce the burden on patients.

I hope that the HITV therapy we have developed and refined will be a beacon of hope for patients with advanced cancer.

Kenichiro Hasumi, M.D.
Chairman, Hasumi International Research Foundation

Greetings from
ICVS Tokyo Clinic,
Dr. Jun Hasumi, MD.

Jun Hasumi

We strive to be close to our patients' conditions and provide safe and secure treatment in our daily consultations.
As cancer immunotherapy continues to develop, all of our staff including myself are constantly incorporating the latest information so that our patients can recover, or work together to prevent recurrence of cancer. Please feel free to contact us.
I sincerely appreciate your trust, and hope you will continue to support us.

Jun Hasumi, M.D.
ICVS Tokyo Clinic

Greetings from
Dr. Kenichiro Hasumi,
MD, and CEO of
ICVS Tokyo Clinic

The time has finally come when we can expect cancer shrinkage or disappearance by IMMUNOTHERAPY alone for advanced cancer.
In the future, IMMUNOTHERAPY is expected to be the main player of cancer treatment, being supported by anticancer drugs and radiotherapy to speed up the healing process.
In the aging society, IMMUNOTHERAPY with fewer side effects will enable people to lead meaningful lives while maintaining their quality of life (QOL) without incurring great costs.
As I have treated patients from more than 20 countries and regions so far, ICVS Tokyo Clinic welcomes inquiries from people overseas.

Doctors atICVS Tokyo Clinic

Note: English speaking doctorsare at workbut not assured to attendyour visit.

Chairman, ICVS Tokyo Clinic Kenichiro Hasumi, M.D.

Dr. Kenichiro Hasumi is a physician, specializing in cancer immunotherapy and terminal care. Graduated from Saitama Medical University. After working at the Institute of Medical Science, University of Tokyo, he became the Chairman and CEO of Hasumi International Research Foundation in USA. He is by nature a researcher and visionary, focused on the development of cancer vaccines and improved clinical treatments to achieve better patient outcomes with a higher quality of life.
He established a research chair at Thomas Jefferson University's Sidney Kimmel Cancer Center, USA, and was a visiting professor at the Cancer Center. He received an honorary doctorate from the Medical University of Pleven, Bulgaria, for his research activities in cancer immunotherapy. He is also involved in collaborative research projects with University of Maryland in USA, Erlangen University in Germany, and clinical trials with Universiti Kebangsaan Malaysia (UKM), respectively.

ICVS Tokyo Clinic Jun Hasumi, M.D.

Graduated from the Jikei University School of Medicine in 2016, Dr. Jun Hasumi had been with the Jikei University Hospitals for about 7 years. He is a specialist in radiology as well as in diagnostic radiology.
Concurrently he has been working at ICVS Tokyo Clinic as a part-time physician since 2020, and also became a member of the Board of Hasumi International Research Foundation in USA.
In September 2023, he was appointed Deputy Director of ICVS Tokyo Clinic.
He became the Director of ICVS Tokyo Clinic in April 2024.
In January 2025, he re-assumed Vice Director of IVCS Tokyo Clinic.

Vice Director Yasuko Kusaka, M.D., Ph.D.

Dr. Kusaka, specializing in neurosurgery, a certified industrial physician, and with a diploma in mountain medicine, graduated from Tohoku University School of Medicine, joined the Department of Neurosurgery, Tohoku University Hospital.
Clinical Training Abroad to Phoenix Neurosurgery in USA and Hanover Neurosurgery in Germany has led her to become a lecturer at the Department of Neurosurgery, the Jikei University School of Medicine in 2004.
She was appointed Director of ICVS Tokyo Clinic in 2018 and served there till March 2021.
She has been the Director of ICVS Tokyo Clinic V2 since December 2022.
In June 2024, she assumed the position of Vice Director at ICVS Tokyo Clinic.

Doctor Akira Takeuchi, M.D., Ph.D. Director ofHigashi Ginza Luke Clinic

After graduating from Saitama Medical University in 1989, he demonstrated "near-infrared laser bone density measurement theory" with the cooperation of the Agency of Industrial Science and Technology, Ministry of International Trade and Industry (then), and in 1994 received a doctorate from Saitama Medical University Graduate School (Department of Endocrinology).
He was in charge of research and treatment of far-infrared hyperthermia (heat therapy), and in 1997 opened Luke Clinic, specializing in advanced cancer treatment.
He introduced cancer ablation therapy (HIFU:high-intensity focused ultrasound) using focused ultrasound and apoptosis sensitization therapy using p53 protein.

Japan Hyperthermia Society instructor

Doctor Sakuzo William Honjo, M.D.

After graduating from the Jikei University School of Medicine, he joined the Department of Radiology at the University. During his tenure, he engaged in image diagnosis and IVR treatment. Wanting to utilize the experience and know-how he had gained in IVR, after leaving the department, he has been working at the ICVS Tokyo Clinic since May 2023.
"I am committed to providing safe procedures with minimal patient burden."

Doctor Makoto Hinotsume, M.D.

After graduating from St. Marianna University School of Medicine, he joined the Radiation Therapy Department at the Jikei University Hospital.
Using the latest medical technology and knowledge, he is determined to provide optimal care to each patient and improve their quality of life.

 
 
 
 

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