Saisei Mirai 2nd Generation High Dose GcMAF macrophage activation therapy

Therapy | Treatment

GcMAF (Gc Protein derived
Macrophage Activating Factor)

For the treatment for cancer, HIV and immune system diseases.

Target diseasesTreatmentGet GcMAF Therapy |

News


Conference presentation - The 17th Annual Meeting of The Society of Biotherapeutic Approaches, Fukuoka University

7-DEC-2013
Case Report: A Breast Cancer Patient Treated with GcMAF, Sonodynamic Therapy and Hormone Therapy (PDF), PPT

Dr Toshio Inui

Dr Toshio Inui Case Report - A Breast Cancer Patient Treated with GcMAF, Sonodynamic Therapy and Hormone Therapy

New research papers published by Saisei Mirai in Anticancer Research available online.

New research papers on GcMAF and integrative cancer immunotherapy treatment written in collaboration with the University of Tokushima, Kanazawa University and Kobe University Graduate School of Medicine researchers and Saisei Mirai published in Anticancer Research journal.

Research paper
2013 Degalactosylated/Desialylated Human Serum Containing GcMAF Induces Macrophage Phagocytic Activity and In Vivo Antitumor Activity (PDF)
Anticancer Res July 2013 33 (7) 2881-2885

Cancer vaccine therapy - autologous tissue derived tumor vaccine Cancer vaccine therapy - autologous tissue derived tumor vaccine Cancer vaccine therapy - autologous tissue derived tumor vaccine

Research paper
2013 Clinical Experience of Integrative Cancer Immunotherapy with GcMAF (PDF)
Anticancer Res July 2013 33 (7) 2917-2919

Cancer vaccine therapy - autologous tissue derived tumor vaccine Cancer vaccine therapy - autologous tissue derived tumor vaccine Cancer vaccine therapy - autologous tissue derived tumor vaccine

Nature Outlook sponsored article

For more details on GcMAF see our GcMAF page.



Experiment report of Gc MAF stability assay
14-JUN-2012 Stability of GcMAF in Serum (PDF)
H Mukai, Y Uto. Department of Biological Science and Technology, The University of Tokushima.

Stability of GcMAF in Serum report Stability of GcMAF in Serum report

The results show that 2nd Generation GcMAF is stable for 1 year at 4 °C, for 14 days at room temperature (around 20 °C), and for 7 days at 40 °C.

See Research and references for more details on experiments on macrophage phagocytic activity and stability of our GcMAF.


Collaborations with the University of Tokushima
We collaborate with GcMAF researchers at the University of Tokushima, Japan in the development of second generation GcMAF. See Research and references for published research papers on Gc-MAF in peer-reviewed scientific journals authored by the University of Tokushima researchers over the last decade. Our research on GcMAF is ongoing and papers are being prepared for publication in collaboration between the University of Tokushima and Saisei Mirai in the next few months.


University of Tokushima, Institute of Technology and Science, Laboratory Research

Our research group:
Working in collaboration University of Tokushima, Institute of Technology and Science Kobe University School of Medicine Kyoto Prefectural University of Medicine Konan University Saisei Mirai Cell Processing Center (CPC)


Background

GcMAF (Gc Protein derived Macrophage Activating Factor) occurs naturally in our bodies and instructs macrophages to destroy cancerous cells and foreign invaders. Serious illnesses like cancer, HIV and viral hepatitis destroy GcMAF and so neutralizes our immune system. This allows the disease to progress uncontrolled.

We use a small sample of serum from healthy human people to produce large amounts of new second generation GcMAF in our specialized sterile laboratory called a Cell Processing Center (CPC). This highly active second generation Gc-MAF is injected intramuscularly or subcutaneously into the patient usually weekly or twice weekly. Over a matter of weeks and months the immune system becomes strengthened through the activation of macrophages, and begins to eradicate cancer cells, viruses and bacteria.

Our principle of treatment is, first do no harm.

Second generation GcMAF

Second generation Gc-MAF is produced using a new Patent Pending process which was developed here in Japan by Saisei Mirai in collaboration with researchers from the University of Tokushima who have been studying GcMAF for over 18 years. Our GcMAF is made in our sterile cell processing facility using this new and improved 2nd generation method which is 10-20 times more concentrated and is more active and stable than other GcMAF that is currently available. Importantly, this much higher concentration GcMAF has been clinically demonstrated to be largely free of any side effects in the great majority of patients and is much more stable because it is resistant to oxidation. Only low grade fever or eczema has been observed in about 1 out of 100 patients using GcMAF, but these were short-term effects.


First Generation GcMAF vs Saisei Mirai Second Generation GcMAF concentration

Concentration of 1st generation and Second Generation GcMAF
  • 0.5 ml of High Dose GcMAF is approximately 1500 ng GcMAF
  • 0.5 ml of Regular Dose GcMAF is approximately 100 ng GcMAF
  • Gc-MAF is a natural immunotherapy product. Variation in GcMAF concentration is due to normal variation between serum samples. In the same way that Lymphocytes or Natural Killer cells vary in number between people and at any given time, so will the amount of GcMAF that can be produced from serum.
  • Our GcMAF is produced under aseptic conditions in a specialized facility and sterile filtration is used in the production of all product.
  • Our new 2nd generation Gc-MAF has been safely used in hundreds of patients in our clinics in Japan, since April 2011. Treatment in our clinics has been by Intramuscular (IM), Subcutaneous (SC), and Intratumoral (IT) injection.

Our specialized sterile Cell Processing Center (CPC) and team of highly skilled laboratory staff


Clean clothes Security doors Microscope work
Clean clothes Security doors Microscope work
Carbon dioxide incubator Centrifuge Sterile cabinet
Carbon dioxide incubator Centrifuge Sterile cabinet


How is our second generation GcMAF made?

Second generation GcMAF is manufactured in our own sterile Saisei Mirai Cell Processing Center (CPC) from serum of healthy people which is carefully screened and the final product sterile filtered to ensure safety. See Tests of our GcMAF below for more details.

Diagram showing steps of our GcMAF preparation process
Steps of High Dose GcMAF production


How is our second generation GcMAF tested for activity?

Our second generation GcMAF is tested for macrophage phagocytic activity using mouse macrophages and sheep red blood cells at the University of Tokushima. The red blood cells are opsonized which marks them for ingestion and destruction by activated macrophages, seen as purple areas in the clear cells. From this we calculate the Phagocytosis (ingestion) Index (PI).

Macrophage phagocytic activity of Second Generation GcMAF
Macrophage phagocytic activity of second generation GcMAF. The purple color are macrophages activated by GcMAF phagocytizing (ingesting) opsonized red blood cells which are clear in color. (Photo courtesy, University of Tokushima)

What are macrophages?

Macrophages (Greek: big eaters) are cells produced by the differentiation of monocytes, a type of white blood cell, in tissues. Macrophages function in both non-specific defense (innate immunity) as well as help initiate specific defense mechanisms (adaptive immunity) of vertebrate animals. Their role is to phagocytose (engulf and then digest) cellular debris and pathogens, either as stationary or as mobile cells. They also stimulate lymphocytes and other immune cells to respond to pathogens. They are specialized phagocytic cells that attack foreign substances, infectious microbes and cancer cells through destruction and ingestion.


M1 macrophages - cancer suppressors
Steps of a macrophage ingesting a pathogen
Steps of a macrophage ingesting a pathogen
a. Ingestion through phagocytosis, a phagosome is formed
b. The fusion of lysosomes with the phagosome creates a phagolysosome; the pathogen is broken down by enzymes
c. Waste material is expelled or assimilated (the latter not pictured)

Parts: 1. Pathogens, 2. Phagosome, 3. Lysosomes, 4. Waste material, 5. Cytoplasm, 6. Cell membrane

Vitamin D binding protein

Vitamin D binding protein is also known as Gc Protein. It is produced in our body, mainly in the liver, especially when we are exposed to the sun. This binding protein binds to 25 (OH) vitamin D in our body for transport and storage. There are different forms of Vitamin D BP, the most dominant being non-glycosylated 656 Da proteins. Vitamin DBP is the most important scavenger of extracellular G-actin, important in liver disease. Vitamin DBP activates macrophages through GaINAc- modified Gc Protein. Vitamin DBP has virtually no impact on the distribution, uptake, activation profile, or biological potency of the hormone vitamin D in our body, so too much is unlikely to be a problem. Vitamin D binding protein is the basic macrophage activating factor in our body.


Factors that influence Vitamin DBP levels

Liver disease decreases levels of Vitamin DBP (Gc Protein). Chronic liver disease will decrease levels less than acute liver failure. Trauma and surgery will decrease Vitamin DBP. Septic infections will consume Vitamin DBP faster than production can be increased.

Normal Vitamin DBP (Gc Protein) levels in serum are 350-500 mg/l. Levels of Gc Protein less than 80 mg/l yield positive and negative mortality predictive values of 85% and 43% respectively. Survivors had levels greater than 102 mg/l.


Macrophage activation factor (MAF)



What is macrophage activation factor?

Macrophage activation factor (MAF) are glycoproteins that increase macrophage activity and transform them into natural killer (NK) cells. Vitamin DBP (Gc Protein) is the primary MAF. The glycosylated Gc Protein is the best MAF.


NaGaLase (Alpha-N-acetylgalactosaminidase)

NaGaLase is an enzyme produced in trace amounts in normal healthy liver cells.


What harm can NaGaLase do?

Alpha-N-acetylgalactosaminidase (alpha-NaGaLase) is produced in large amounts by cancer cells. alpha-NaGaLase deglycosylates the trisaccharide of Gc Protein at step prior to the final isoform of MAF. alpha-NaGaLase from tumors induces an immunosuppressive state that allows the cancer to spread and eventually results in death by infection.


What good can NaGaLase do?

Endo-alpha-N-acetylgalactosaminidase is produced in small amounts by probiotic bifodobacterium. NaGaLase produced in the intestine by our probiotics serves a role in breaking down mucin glycoproteins in our food.


Where else is NaGaLase found?

NaGaLase is also produced by bacteria, virus infected cells and fungi.


Normal serum levels of NaGaLase

Normal levels of NaGaLase range between 0.38 to 0.63 nmole/min/mg protein. People with cancer have NaGaLase above 2.32 nmole/min/mg protein.

Radiation therapy decreases the number of cancerous cells capable of secreting alpha-NaGaLase. Radiation also increases Gc Protein activation to principle MAF. Radiotherapy and photodynamic therapy decreases NaGaLase activity.

Target diseases for GcMAF therapy

  • Gc-MAF macrophage activation therapy is useful in the treatment of many diseases, such as cancer, HIV AIDS, Hepatitis B virus (HBV), Hepatitis C virus (HCV), Herpes Simplex virus (HSV), Tuberculosis, Pneumonia infection, Epstein-Barr virus (EBV), cystitis/urinary tract infection (UTI), Endometriosis, Selective IgA deficiency disorder and influenza virus.
  • In healthy individuals the immune system may be able to overcome many kinds of diseases, however people with a compromised immune system will benefit from GcMAF therapy.
  • In the great majority of people there are no side-effects with our 2nd generation Gc-MAF therapy, or side-effects are very minor and extremely rare. Low grade fever and eczema has been observed in about 1 out of 100 patients using GcMAF, but these were short-term effects.
  • Treatment in our clinics has been by Intramuscular (IM), Subcutaneous (SC), and Intratumoral (IT) injection.

In combination with other treatments

GcMAF can be safely used with a wide variety of other standard treatments and drugs to improve their effect. We refer to this as integrative medicine.

  • In combination with anti-cancer drugs and radiation therapy (radiotherapy) is possible. For maximum effect and benefit from GcMAF, administer a few days apart from chemotherapy. Radiation therapy does not have significant effects on Gc-MAF, so both can be used together at any time. In our clinical experience we have observed significant cancer killing effects from GcMAF combined with palliative radiotherapy in patients who have had significant prior treatment with chemotherapy. See our Case Reports for more details on this multimodality integrative treatment.
  • Studies show that GcMAF has anti-angiogenic activity in addition to tumor killing activity through the activation of macrophages.
  • GcMAF can be combined with Sonodynamic Therapy (SDT), Photodynamic Therapy (PDT) or both (Sonophotodynamic Therapy, SPDT), Maitake Extract, Coley Vaccine (Coley Fluid), high dose IV Vitamin C, low dose Naltrexone (LDN), Alpha-Lipoic Acid, hyperthermia therapy, immunotherapies and cancer vaccines (such as autologous cancer vaccine).
  • GcMAF should be used in combination with at least 5,000 IU vitamin D3 daily. Blood levels of vitamin D are often low in many kinds of diseases, such as cancer, HIV AIDS, etc. Normal vitamin D levels are necessary in order for GcMAF to work fully. Ask to have your blood 25 hydroxy-vitamin D as well as calcium levels tested. If blood calcium levels become elevated, the dose of vitamin D3 may need to be reduced to achieve optimal balance.

Things to avoid

Gc-MAF can be safely used with a wide variety of drugs and other treatments however we recommend:

  • Minimal use of steroids is desirable because of their immune suppressing effect, however steroids may be safely used with GcMAF if necessary and prescribed by your doctor.
  • Radiation therapy is preferred over chemotherapy, if possible.

Treatment

  • Treatment is by Intramuscular (IM) or Subcutaneous (SC) injection of GcMAF macrophage activating factor, 1-2 times per week (or as prescribed by the treating medical doctor). See Dosing recommendations below.
  • Treatment in our clinics has also been by Intratumoral (IT) injection, although IM and SC injection is by far the most common means of administration.
  • Good aseptic technique with ethanol is required when using the vials.

Dosing recommendations for Second Generation GcMAF

  • Dosage and frequency of Gc-MAF administration is at the discretion of the treating doctor and/or the patient.
  • No upper limit has been established for second generation GcMAF.

Cancer, HIV AIDS, Hepatitis, Tuberculosis:

For cancer patients, HIV AIDS, Hepatitis, Tuberculosis we suggest 1500 ng High Dose GcMAF once or twice per week.

  • For maximum effect we recommend 0.5 ml twice weekly.
  • One course of High Dose GcMAF is usually 48 doses for 6 months. Additional courses may be required depending on stage of disease and severity of symptoms.

Macrophage activation is always necessary for the effective functioning of the immune system. Gc-MAF therapy should continue while there is disease present and for a period after to reduce the chance of recurrence.



Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME):

In Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME), a lower dosage of 100 ng Low Dose GcMAF once per week is commonly recommended. With Second Generation GcMAF we recommend using High Dose GcMAF for more effective treatment.

  • Recommended dose - 0.25ml High Dose GcMAF, twice weekly by intramuscular or subcutaneous injection. *

  • Some improvements in symptoms should be observed within 2 months.
  • Minimum treatment course of 6 months should be expected, but each patient is different and additional courses may be required based on positive progress.
  • Patients may need longer term maintenance doses of GcMAF therapy to stay well and symptom free until their immune system is fully recovered enough to cope with challenges.
  • If patients are are already using 100 ng Low Dose GcMAF and the effects from the treatment are not pronounced, we recommend switching to Second Generation High Dose GcMAF.
  • In our clinics in Japan, all of our patients, regardless of the disease, use second generation High Dose GcMAF.

* These dosage recommendations apply only to Saisei Mirai Second Generation GcMAF.


Autism Spectrum Disorders (ASD):
  • Recommended dose - 0.25ml High Dose GcMAF, twice weekly by intramuscular or subcutaneous injection. *

  • Some improvements in symptoms should be observed within 2 months.
  • Minimum treatment course of 6 months should be expected, but each individual patient is different and additional courses may be required based on positive progress.
  • Patients may need longer term maintenance doses of GcMAF therapy to stay well and symptom free until their immune system is fully developed enough to cope with challenges.
  • See our Autism Spectrum Disorders (ASD) page for more details on Autism.

* These dosage recommendations apply only to Saisei Mirai Second Generation GcMAF.



GcMAF Therapy

If you wish to get GcMAF therapy, please contact us by email with details of your disease, current treatment and the quantities of GcMAF you require. Below are details about pricing and payment.


High Dose GcMAF 2.5 ml multi-dose vials (1500 ng/0.5 ml):

2 vials x 2.5 ml GcMAF (1500 ng/0.5 ml) 8 doses -- please contact us for pricing

4 vials x 2.5 ml GcMAF (1500 ng/0.5 ml) 16 doses -- please contact us for pricing

6 vials x 2.5 ml GcMAF (1500 ng/0.5 ml) 24 doses -- please contact us for pricing

Regular Dose GcMAF 2.5 ml multi-dose vials (100 ng/0.5 ml):

2 vials x 2.5 ml GcMAF (100 ng/0.5 ml) 8 doses -- 64,200 yen

4 vials x 2.5 ml GcMAF (100 ng/0.5ml) 16 doses -- 120,200 yen

6 vials x 2.5 ml GcMAF (100 ng/0.5 ml) 24 doses -- 176,200 yen

  • Each multi-dose vial contains at least 4 doses GcMAF at 0.5 ml/dose. Vials are overfilled to 2.5 ml, so up to 5 doses GcMAF may be possible for each vial.
  • Prices include 8200 yen for shipping and handling by EMS International Express Mail Service worldwide.
  • Keep vials refrigerated at around 2-8 °C for multi-dose use. For long term storage > 1 year, vials maybe be kept frozen and defrosted once for multi-dose use. Due to much improved stability of our second generation GcMAF, freezing is usually not necessary.
  • Please contact us if you require other quantities.


Payment information

Payment is by wire transfer to our account in Japan. After you confirm your order with us, simply make your wire transfer (see details below). Please ensure that funds are sent as Japanese Yen (JPY) so that the correct amount is received by us. Once you have made your transfer, please let us know the details of the transfer (such as the name of sender), so that we can identify you more quickly. As soon as we confirm your payment, we will ship your Gc-MAF on the next suitable day depending on the destination.



Wire transfer details (International Telegraphic Transfer):

Beneficiary:  Imagin-K Co. Ltd

Beneficiary address:  3-34-8 Okubo-cho, Moriguchi-shi, Osaka 570-0012, Japan

Name of bank:  Sumitomo Mitsui Banking Corporation, Neyagawa Branch

Bank Address:  16-14 Hayako-cho, Neyagawa-shi, Osaka 572-0837, Japan

Account number:  7038812

SWIFT:  SMBCJPJT   (or BIC:  SMBCJPJTXXX)


  • Visit your bank and ask the staff to make a wire transfer from your account. Alternatively, you may be able to do this online via your bank's internet banking service, if you have this set up.
  • Funds should be sent as Japanese Yen (JPY).
  • Note: International Bank Account Number (IBAN) is not used in Japan.
  • Internet banking: Some websites don't allow a dash to be included in the postal code, so if necessary, the dash may be omitted so that the post code/ZIP code becomes one number (e.g., 570-0012 becomes 5700012).
  • Please ensure you provide us with your full name, shipping address and a contact telephone number when you order.


  • GcMAF is a natural immunotherapy product. Variation in GcMAF concentration is due to normal variation between blood samples. Just like Lymphocytes or Natural Killer cells vary in number between people and at any given time, so will the amount of Gc-MAF.
  • Charges for shipping and handling apply to each order. We use EMS International Express Mail Service with tracking information. Each package includes cooling packs to keep GcMAF at a stable temperature during shipping. Our second generation GcMAF is strong enough at room temperature to maintain a high level of activity for the days in transit. See more details about the Stability of GcMAF in Serum (PDF) report under Research and references below for experiment done by the University of Tokushima on stability by phagocytic activity of our GcMAF after short-term and long-term storage.
  • We ship Gc-MAF as a liquid in high quality multi-dose vials. After arrival the vials should be stored in the refrigerator to maintain maximum activity until each injection.


  • Estimated stability of Second Generation GcMAF

    Activity remains stable at room temperature for a minimum of 2 weeks and at least 1 year refrigerated (2-8 °C). Our most recent tests indicate that Second Generation GcMAF is stable for 4 weeks at room temperature without loss in activity.


    Shipping notes

    We use special packaging and cooling packs to keep the temperature of the vials stable. Gc-MAF is strong enough at room temperature to maintain a high level of activity for the days in transit. See Tests of our GcMAF and Research and references below for more details. The GcMAF is expected to reach you in excellent condition with no loss in activity. We ship fresh Gc-MAF as a liquid. After arrival the vials containing GcMAF should be stored refrigerated to maintain maximum activity for multi-dose use.

    Tests of our GcMAF

    Gc-MAF is made in our state of the art sterile cell processing facility using a new and improved 2nd generation method which contains 10-20 times more GcMAF and is more active and stable than other GcMAF that is currently available. To ensure the highest level of quality and safety, our GcMAF is carefully tested and screened. All GcMAF is sterile filtered using a 0.22 micron filtration system and tested for endotoxins before it leaves the laboratory.


    Our screening process includes the following:

    TPHA Test (Syphilis), HBs Antigen, HBc Antibody, HBe Antigen, HCV Antibody, HIV Antigen and Antibody, HTLV1 Antibody (Adult T-cell Leukemia), Endotoxins.


    GcMAF activity tests:

    Activity experiments conducted by researchers at the University of Tokushima. These test results apply only to our 2nd generation GcMAF.

    GcMAF activity levels in a variety of conditions:
    • Room temperature (10-15 °C) for 14 days - no significant change in activity
    • 40 °C for 7 days - no significant change in activity
    • 1 year refrigerated - no significant change in activity
    Summary:
    • Tests indicate that our 2nd generation GcMAF is very temperature stable and retains maximum activity level even after 1-2 weeks at temperatures as high as 40 °C.
    • This makes our Gc-MAF stable enough for shipping worldwide without significant loss in activity during that time.
    • Maximum activity is also retained after 1 year stored in the refrigerator.

    Research and references

    Please refer to our Research and references page for detailed information.





    Imagin-K

    Contact us
    GcMAF
    Treatments and therapies
    Saisei Mirai Clinics
    Kobe Saisei Mirai Clinic
    • Cancer
    • Skin regeneration
    • Skin rejuvenation
    • Anti-aging
    医療法人 再生未来

    Boeki Center Building
    23rd Floor
    5-1-14 Hamabetori Chuo-ku
    Kobe-shi
    Hyogo-ken 651-0083
    Japan


    Inui Cancer Immunotherapy Clinic
    Inui Cancer Immunotherapy Clinic
    • Cancer
    • Hepatitis
    • Chronic diseases

    6-14-17 Kinndachou
    Moriguchi-shi
    Osaka 570-0011
    Japan
    TEL: +81 (0)6-6902-5251
    FAX: +81 (0)6-6902-7133


    Keihan Clinic
    • Cancer
    • Hepatitis
    • Chronic diseases
    • Anti-aging
    Saisei Mirai Keihan Clinic

    Nature 21 Building
    2nd Floor
    3-34-8 Okubo-cho
    Moriguchi-shi
    Osaka 570-0012
    Japan
    TEL: +81 (0)6-6902-1001


    iTokyo Clinic
    • Cancer
    • Skin regeneration
    • Skin rejuvenation
    • Anti-aging
    Saisei Mirai iTokyo Clinic

    Shirokanedai Crest Building
    7th Floor
    4-2-11 Shirokanedai
    Minato-ku
    Tokyo-to 108-0071
    Japan


    Kobe Infectious Diseases Clinic
    • HIV AIDS
    • Hepatitis B (HBV)
    • Hepatitis C (HCV)
    Kobe Infectious Diseases Clinic

    Boeki Center Building
    11th Floor
    5-1-14 Hamabetori Chuo-ku
    Kobe-shi
    Hyogo-ken 651-0083
    Japan