Saisei Mirai 2nd Generation High Dose GcMAF therapy FAQ

Frequently asked questions (FAQ)

Frequently asked questions about Second Generation GcMAF by Saisei Mirai.
General GcMAF questions
  • Who is Saisei Mirai?
  • What is GcMAF?
  • What are macrophages?
  • Where are macrophages found in the body?
  • How does GcMAF work?
Second Generation GcMAF
  • What exactly is Second Generation GcMAF?
  • How is this new GcMAF different from previous GcMAF preparations?
  • How is GcMAF tested for activity?
  • How stable is Second Generation GcMAF?
  • How long have you been producing Second Generation GcMAF?
  • Where do you produce Second Generation GcMAF?
  • What other immunotherapies do you produce?
Oral GcMAF
  • What is Oral GcMAF?
  • How is Oral GcMAF different from Second Generation GcMAF?
  • Who can take Oral GcMAF?
  • Is Oral GcMAF a replacement for Second Generation GcMAF?
  • What are the commonly observed clinical effects of Oral GcMAF?
  • Is Oral GcMAF tested for activity?
  • How long does Oral GcMAF remain active?
  • Where is Oral GcMAF produced?
GcMAF Therapy
  • What diseases can benefit from GcMAF therapy?
  • What is the usual dose of GcMAF therapy?
  • How long should GcMAF therapy be continued?
  • How is GcMAF administered?
  • What tests should be done during GcMAF therapy?
  • Are there any side effects with GcMAF?
  • Can GcMAF be used with other conventional therapies?
  • Are there any supplements I need to take with GcMAF?
  • What should I avoid while using GcMAF?
  • Is Nagalase testing necessary for GcMAF therapy?
Ordering and shipping
  • How can I pay for GcMAF therapy?
  • How long does it take for my package to arrive?
  • How much does shipping and handling cost?
  • How is GcMAF packaged for shipping?

General

Who is Saisei Mirai?
Saisei Mirai is a medical organisation in Osaka, Japan with the purpose of treating patients and developing and producing therapies, in particular immunotherapies such as GcMAF. We work with other clinics and doctors both here and in Japan, as well as with various universities conducting clinical trials and doing research & development.
Saisei Mirai is a medical organisation in Osaka Japan



What is GcMAF?
GcMAF (Gc Protein derived Macrophage Activating Factor) occurs naturally in our bodies and instructs macrophages to destroy cancerous cells and foreign invaders by activating them.
What are macrophages?
Macrophages (Greek: big eaters) are cells originating from monocytes, a type of white blood cell found in the body. 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 phagocytize (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.

Mouse macrophage stretching its arms (pseudopodia) to engulf two particles A macrophage of a mouse stretching its "arms" (pseudopodia) to engulf two particles, possibly pathogens.
Where are macrophages found in the body?
Macrophages and other phagocytes are found in the following locations in the body:


Main location Types of phagocytes
Skin * macrophages, resident Langerhans cells, dendritic cells, mast cells
Gut and intestinal Peyer's patches * macrophages
Lungs * macrophages, monocytes, mast cells, dendritic cells
Blood neutrophils, monocytes
Bone marrow macrophages, monocytes, sinusoidal cells, lining cells
Connective tissue macrophages, monocytes, dendritic cells, histiocytes
Lymphoid tissue macrophages, monocytes, dendritic cells
Spleen macrophages, monocytes, sinusoidal cells
Thymus macrophages, monocytes

* These locations offer the best sites for GcMAF administration. The skin by subcutaneous (SC) or intramuscular (IM) injection, the gut by oral administration and the lungs by inhalation using a nebulizer (such as Omron NE-U22V Portable Nebulizer).
How does GcMAF work?
GcMAF is a glycoprotein that activates macrophages which in turn increases macrophage activity and transforms them into Natural Killer (NK) cells.

Second Generation GcMAF

What exactly is Second Generation GcMAF?
High Dose Second Generation Gc-MAF is produced using our new Patent Pending process which was developed here in Japan by Saisei Mirai in collaboration with Dr Hitoshi Hori and Dr Yoshihiro Uto at the University of Tokushima who have been studying GcMAF for over 20 years. Studies on GcMAF began at the University of Tokushima in 1992, after they were introduced to Dr Nobuto Yamamoto's work and a collaboration began.
University of Tokushima, Institute of Technology and Science, Laboratory Research



How is this new GcMAF different from previous GcMAF preparations?
Second Generation GcMAF is made using a new and improved 2nd generation method of Gc-MAF production 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.

First Generation GcMAF vs Saisei Mirai Second Generation GcMAF concentration

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

See also Tests of Second Generation GcMAF for more details.
How stable is Second Generation GcMAF?
Second Generation GcMAF is stable for a minimum of 2 weeks at room temperature. See our Stability of GcMAF in Serum (PDF) report produced by Tokushima University. We completed a longer stability experiment which found that Second Generation GcMAF is stable for 4 weeks at room temperature without loss in macrophage activation activity so the GcMAF remains highly potent. We estimate from our experiments that our GcMAF remains highly active without loss in activity for at least 1 month at room temperature. Refrigerated there is no loss in activity for over 1 year.
How long have you been producing Second Generation GcMAF?
Saisei Mirai has been producing our Patented Second Generation GcMAF since 2011 and our doctors have treated over 1000 patients in our Saisei Mirai group of clinics in Japan.
Where do you produce Second Generation GcMAF?
We produce GcMAF in our own Saisei Mirai Cell Processing Center (CPC) in Osaka, Japan.

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
What other immunotherapies do you produce?
In addition to GcMAF we produce NK cells (which we call Hyper T/NK Cell Therapy), lymphocytes and dendritic cells (DC). We are continuously researching and developing new immunotherapies for patients in collaboration with various universities in Japan.

Oral GcMAF

What is Oral GcMAF?
Oral GcMAF is a form of GcMAF produced from bovine colostrum by Saisei Mirai which was developed in collaboration with Tokushima University.

Oral GcMAF made from bovine colostrum Oral GcMAF made from bovine colostrum.
How is Oral GcMAF different from Second Generation GcMAF?
Oral GcMAF is produced in a similar way to Second Generation GcMAF but uses bovine colostrum instead of serum. It is administered orally and sublingually. See GcMAF Therapy for more details below.
Who can take Oral GcMAF?
Anyone can take Oral GcMAF to stay healthy and fight off disease.
Is Oral GcMAF a replacement for Second Generation Gc-MAF?
For most serious diseases we recommend a combination of Oral GcMAF and GcMAF injections. Because the site of administration is different so too is the area of macrophage activation and the effect.
What are the commonly observed clinical effects of Oral GcMAF?
We have observed a number of common clinical effects from Oral GcMAF, such as:
  • Improved sleep, more energy; reduced fatigue
  • Improved digestion, reduced nocturnal urination
  • Improved hair regrowth and reduced hair loss due to natural ageing
  • Improved skin condition & smoothness
  • Improved control or curing of infectious diseases such as virus, bacteria and other pathogens
  • Reduced allergy symptoms, pollinosis and atopy
Is oral GcMAF tested for activity?
Oral GcMAF is tested for macrophage phagocytic activity using mouse macrophages and sheep red blood cells at the University of Tokushima, Japan. See How is GcMAF tested for activity? under Second Generation GcMAF above and Tests of Second Generation GcMAF for more details.
How long does Oral GcMAF remain active?
Oral GcMAF is stable with high macrophage phagocytic activity for at least 1 year. Long-term stability testing is currently being conducted. To maintain maximum long-term activity we recommend Oral MAF be stored refrigerated.
Where is Oral GcMAF produced?
Oral GcMAF is produced in GMP facilities in Japan.

GcMAF Therapy

What diseases can benefit from GcMAF therapy?
Gc-MAF and/or oral Colostrum MAF macrophage activation therapy is indicated in the treatment of any diseases where there is immune disfunction or where the immune system is compromised, such as:

Cancer Autoimmune diseases Epstein-Barr Virus (EBV)
Hepatitis B virus (HBV) Herpes Simplex virus (HSV) Cystitis
Hepatitis C virus (HCV) Multiple sclerosis (MS) Urinary tract infection (UTI)
Autism Spectrum Disorders (ASD) Rheumatoid arthritis (RA) Endometriosis
Chronic Fatigue Syndrome (CFS) Lyme disease (Lyme borreliosis) IgA deficiency disorder
Myalgic Encephalomyelitis (ME) Mycobacteria infections Parkinson's disease
Tuberculosis Fibromyalgia Human papillomavirus (HPV)
Lupus (Systemic lupus erythematosus, SLE) HIV AIDS Dengue fever
Pneumonia infection Warts caused by viral infection Norovirus
Malaria Influenza virus (flu) Herpes simplex virus (HSV)
Q fever (Coxiella burnetii) Polycystic ovary syndrome (PCOS) Chicken pox (varicella zoster virus)
Psoriasis Respiratory tract infections Ulcerative colitis, Crohn's disease
Type 1 diabetes (T1DM), insulin-dependent diabetes (IDDM) Type 1.5 diabetes, Latent autoimmune diabetes of adults (LADA)  
What is the usual dose of GcMAF therapy?
Cancer: For Second Generation GcMAF therapy we recommend 0.5 ml High Dose GcMAF (1500 ng/0.5 ml) 2-3 times a week in an integrative approach to treating cancer.
  • More frequent dosing (daily or every second day) may be safely used with more advanced stage of disease, or initially in the treatment course.
  • GcMAF may also be administered by intravenous (IV) injection, 0.5-1.0 ml 2-3 times per week in 20 ml or more saline, if deemed necessary, such as for advanced cases.
  • We recommend IV GcMAF in addition to the usual IM/SC injections every week. These can be done on alternate days.
Other diseases (such as Autism, CFS, ME, Lyme disease): We recommend 0.25 ml High Dose GcMAF (1500 ng/0.5 ml) 2-3 times a week. Initial doses can start at 0.1 ml in the 1st week, 0.2 ml in the 2nd week, and 0.25 ml or 0.3 ml in the 3rd week. A higher dose of 0.5 ml 2-3 times per week may be required depending on the initial response. See our Autism Spectrum Disorders (ASD) page for more details on Autism.
How is GcMAF administered?
GcMAF is administered by subcutaneous (SC) or intramuscular (IM) injection, 2-3 times per week (or as prescribed by the treating medical doctor) using a Size 26G x 1/2" (0.45 x 13 mm) or Size 27G needle with a 2.5 ml or 1 ml syringe (single use, sterile disposable). The larger 2.5 ml syringe is easier to use due to the shorter plunger stroke distance necessary during injection. Diabetes needles may also be sufficient for administration of GcMAF, although these are a finer needle.

Treatment in our clinics has also been by intravenous (IV) and intratumoral (IT) injection, although IM and SC injection is by far the most common means of administration for most patients. Good aseptic technique using pharmaceutical ethanol (ethyl alcohol) to swab the top of vials before inserting needles is required when using the vials.


Various other methods of administration are possible:

Intravenous (IV) injection

GcMAF may be administered by intravenous (IV) infusion (drip) or by push IV. The usual dose is 0.5-1.0 ml 2-3 times per week in 20 ml or more saline. When given by push IV, 20 ml saline and GcMAF solution is administered in a 20 or 30 ml syringe for 3 minutes or longer.

Inhalation of GcMAF using a Nebulizer

Another option of administration is using a Nebulizer to activate macrophages in the bronchus-associated lymphoid tissue (BALT) of the lungs, for example, using a device such as the Omron NE-U22 Portable Nebuliser. This method of administration is particularly well suited to diseases of the lungs where local administation can have greater effect.

Omron NE-U22 Portable Nebuliser Omron NE-U22 Portable Nebuliser for administration in the lungs to activate macrophages in the Bronchus-Associated Lymphoid Tissue (BALT) of the lungs.

Oral administration using Colostrum MAF in Enteric capsules

Saisei Mirai Oral Colostrum MAF in Enteric capsules provides another means of administation in the Gut Associated Lymphoid Tissue (GALT).

When we swallow Colostrum MAF orally by mouth inside the Enteric capsule (which doesn't get digested in the acid environment of the stomach), the Colostrum MAF reaches the gut and activates macrophages in the Peyer's Patches in the Gut Associated Lymphoid Tissue (GALT). The gut-associated lymphoid tissue accounts for about 70 % of our body's immune system. Oral administration is best on an empty stomach before food in the morning, before bedtime or about 30 minutes before meals to allow quicker passage of the capsule through the stomach to the gut.


Macrophages are abundant in the Peyer's patches of the intestines
Macrophages are abundant in the Peyer's patches of the intestines.

Oral administration using Colostrum MAF powder in the mouth

In the mouth and throat there is the lymphoid tissue which contains macrophages. When we administer oral Colostrum MAF powder by opening the capsules and putting the powder in our mouth for 15-20 minutes, or longer, these macrophages become activated. It's also possible that some GcMAF is absorbed sublingually through the blood vessels in the mouth, however the activation of macrophages in the lymphoid tissue of the throat is believed to be the most important method. Lymphoid tissue is the part of the body's immune system that is important for the immune response and helps protect it from infection and foreign bodies. For example, people who suffer from Immunoglobulin A (IgA) and Immunoglobulin M (IgM) deficiency can benefit from this form of administration.
Lymphoid tissue of the mouth
Lymphoid tissue of the mouth
How long should GcMAF therapy be continued?
One course of High Dose GcMAF is usually expected to be 48 doses for 6 months. Additional courses may be required depending on stage and type of disease, and based on disease symptoms, pathology and progress of improvement. Treatment with GcMAF should be continued as long as necessary while disease is present. Long term maintenance doses of GcMAF may be required depending on the type of disease. Maintenance doses are usually once a week or every 2 weeks administration.

As a general note, macrophage activation is always necessary for the effective functioning of the immune system to stay well and disease-free. GcMAF therapy should continue while there is disease present and for a period after to reduce the chance of recurrence for prevention.
What tests should be done during GcMAF therapy?
We recommend checking tumor markers and regular MRI, PET and CT scans.

Monocyte Count: A patients monocyte count will generally rise in the early stages of GcMAF treatment and indicates a response to GcMAF.

Increase in Monocyte percentage with High Dose GcMAF therapy


Increase in Monocyte number with High Dose GcMAF therapy

  • Example of monocyte count of Stage 4 Breast Cancer patient taking 0.5 ml High Dose GcMAF (1500 ng/0.5 ml) twice weekly by intramuscular injection during cancer treatment at Saisei Mirai clinics in Japan.
Are there any side effects with GcMAF?
Second Generation GcMAF has been clinically demonstrated to be largely free of any side effects in the great majority of patients. Only low grade fever or eczema has been observed in only about 1 out of 100 patients using Second Generation GcMAF, but these were short-term effects that are significantly less than occur with most other immunotherapies. In small numbers of patients local injection site skin reactions occur which can be easily treated with a local non-steroidal anti-inflammatory patch.
Can GcMAF be used with other conventional therapies?
Generally, yes. GcMAF can be safely used with a wide variety of other standard treatments and drugs to improve their effect. We refer to this as multimodality integrative medicine. Some therapies for cancer such as chemotherapy will reduce immune activity which will have some impact on GcMAF, however chemotherapy effectiveness can be increased in combination with GcMAF. Radiation for cancer has less negative impact on the immune system and the cancer killing effects helps macrophages to target the tumors and destroy it.

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.
Are there any supplements I need to take with GcMAF?
GcMAF is usually combination with about 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.
What should I avoid while using GcMAF?
Gc-MAF can be safely used with a wide variety of drugs and other treatments however minimal use of steroids is desirable because of their immune suppressing effect, however they may be safely used with GcMAF if necessary and prescribed by your doctor.
Is Nagalase testing necessary for GcMAF therapy?
Nagalase testing is not required for GcMAF therapy because macrophage activation is always necessary for the effective functioning of the immune system to destroy cancer cells, bacteria and viruses. GcMAF therapy should continue while there is disease present, regardless of Nagalase status.

Ordering and Shipping

How can I pay for GcMAF therapy?
Payment is by wire transfer (telegraphic transfer) to our bank account in Japan. Please contact us to confirm your order and then simply make your wire transfer.
How long does it take for my package to arrive?
It usually takes 3-6 days to ship to the US, Europe, Australia and New Zealand. Some delays can occur for various reasons, but this will not affect the stability of Second Generation GcMAF. Please refer to our Stability of GcMAF experiment report.
How much does shipping and handling cost?
Shipping and handling is 8,200 yen worldwide. Prices include shipping and handling costs. Shipping can be calculated for other couriers such as UPS.
How is GcMAF packaged for shipping?
The GcMAF is packaged in an insulated shipping box with ice packs to keep the temperature stable during shipping. Second Generation GcMAF activity does not decrease during shipping even at room temperature and temperatures as high as 40 °C (140 °F). Please refer to our Stability of GcMAF experiment report.


If you wish to purchase GcMAF therapy or make an enquiry, please contact us with details of your disease, current treatment and the quantities of Gc-MAF you require.



News

Heart Pharmacy Site is now open.

Site which can be purchased is colostrum MAF is now open. By all means, please use

Heart Pharmacy website


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

Research paper
2016 Case Report: GcMAF Treatment in a Patient with Multiple Sclerosis (PDF)
ANTICANCER RESEARCH 36: 3771-3774 (2016)

Case Report: GcMAF Treatment in a Patient with Multiple Sclerosis Case Report: GcMAF Treatment in a Patient with Multiple Sclerosis Case Report: GcMAF Treatment in a Patient with Multiple Sclerosis

Research paper
2016 Case Report: A Non-small Cell Lung Cancer Patient Treated with GcMAF, Sonodynamic Therapy and Tumor Treating Fields (PDF)
ANTICANCER RESEARCH 36: 3767-3770 (2016)

Case Report: A Non-small Cell Lung Cancer Patient Treated with GcMAF, Sonodynamic Therapy and Tumor Treating Fields Case Report: A Non-small Cell Lung Cancer Patient Treated with GcMAF, Sonodynamic Therapy and Tumor Treating Fields Case Report: A Non-small Cell Lung Cancer Patient Treated with GcMAF, Sonodynamic Therapy and Tumor Treating Fields

Research paper
2016 Macrophages Exhibit a Large Repertoire of Activation States via Multiple Mechanisms of Macrophage-activating Factors (PDF)
ANTICANCER RESEARCH 36: 3619-3624 (2016)

Macrophages Exhibit a Large Repertoire of Activation States via Multiple Mechanisms of Macrophage-activating Factors Macrophages Exhibit a Large Repertoire of Activation States via Multiple Mechanisms of Macrophage-activating Factors Macrophages Exhibit a Large Repertoire of Activation States via Multiple Mechanisms of Macrophage-activating Factors

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

New research papers on Oral Colostrum GcMAF for Chronic Fatigue Syndrome (CFS) and serious infection published in Anticancer Research journal.

Research paper
2015 Oral Colostrum Macrophage-activating Factor for Serious Infection and Chronic Fatigue Syndrome: Three Case Reports (PDF)
Anticancer Res August 2015 35 (8) 4545-4549

Conference presentation - 10th International Congress for Medical Laser Applications, Germany

13-JUN-2015
Clinical application of Second Generation GcMAF and oral GcMAF
Dr Toshio Inui

Clinical application of Second Generation GcMAF and oral GcMAF
ISLA website

Conference presentation - 9th International Congress for Medical Laser Applications, Germany

29-JUN-2014
Indications for GcMAF for immunotherapy of cancers and chronic viral and bacterial infections (PDF)

Dr Toshio Inui

Dr Toshio Inui Indications for GcMAF for immunotherapy of cancers and chronic viral and bacterial infections

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:

Imagin-K

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