- Colostrum MAF
- Oral Colostrum MAF administration
- Who is Saisei Mirai?
- What is GcMAF?
- What are macrophages?
- Where are macrophages found in the body?
- How does GcMAF work?
- How is GcMAF produced in our body?
- What is Nagalase?
- What is the comparison between 1st Generation GcMAF and 2nd 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?
- 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?
- 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?
We now also have Saisei Mirai oral Colostrum MAF in special Enteric capsules manufactured in a GMP facility in Japan. We recommend daily oral Colostrum MAF in combination with GcMAF injections for patients with cancer and other serious diseases. Oral MAF can also be used on it's own without the injections for treating many kinds of other diseases such as Autism, infectious diseases and Chronic Fatigue Syndrome (CFS).
* Colostrum GcMAF is taken every day orally (in an Enteric acid-resistant capsule) and sublingually as a powder by opening the capsule and putting the contents in the mouth for about 10-15 minutes for maximum effect. This should be on an empty stomach to allow easy passage to the gut.
* Activating macrophages in different places in the body - administered by injection, orally, sublingually, topically, using a nebulizer - is important for more complete effect all over the body and to treat a greater range of common symptoms.
* According to our activity experiments, 1 capsule of Oral Colostrum MAF is equivalent to approximately 100ng first generation GcMAF.
Commonly observed clinical effects of oral Colostrum MAF:
- Improved sleep, more energy and general wellbeing; reduced fatigue
- Improved digestion and bladder control; reduced frequency of nocturnal urination (nocturia)
- Improved hair regrowth after chemotherapy and reduced hair loss due to natural ageing
- Improved skin condition, reduced allergies and atopy, dermatitis symptoms
- Improved control or eradication of infectious diseases such as virus, bacteria and other pathogens
Please refer to our website page "Tests of Second Generation GcMAF" for activity tests of GcMAF and oral Colostrum MAF and our Frequently asked questions (FAQ) page for more information on all administration methods and general questions. Links can be found in the right side column from the main GcMAF section.
Second Generation GcMAF should be stored refrigerated for multi-dose use and will stay fully active for over 1 year. However, for expected storage longer than 2 or 3 months, vials may be immediately stored frozen and then each vial refrigerated at the beginning of multi-dose use.
Stability tests indicate that 2nd Generation GcMAF is very temperature stable and retains maximum activity even after 4 weeks at room temperature and 1 week at 40 °C (104 °F). Shipping will not affect the activity of the product. Please refer to our Stability of GcMAF experiment report on our website for laboratory data.
* Take 1 capsule orally with water, followed by 1 capsule sublingually first thing in the morning at least 30 minutes before food.
* For higher doses, take orally and sublingually twice daily (total 4 capsules/day).
* Oral administration is best on an empty stomach about 30 minutes before food in the morning or 30 minutes before other meals, or at least 2 hours after. This is to allow quicker passage of the special acid-resistant enteric capsule through the stomach and into the gut.
* For sublingual administration open the capsule and empty capsule powder into the mouth. If possible allow about 15-20 minutes for absorption in the mouth and throat, gradually swallowing when necessary. Avoid eating or drinking soon after, to continue absorbing the GcMAF for longer in the throat.
* Take a daily oral vitamin D3 supplement, 5000 IU or a dose to achieve a blood level of between 70-100 ng/ml (175-250 nmol/l) for treatment. After treatment maintain a level of 50-70 ng/ml (125-175 nmol/l).
Storage: To maintain maximum activity of Oral Colostrum MAF, please store bottles well sealed and refrigerated or in a cool dry place. The product will remain fully active for 1 year or longer when refrigerated. During daily use, bottles may be kept without refrigeration.
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.
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.
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.
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|
|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|
* 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).
GcMAF is a glycoprotein that activates macrophages which in turn increases macrophage activity and transforms them into Natural Killer (NK) cells.
Our phagocytic activity data shows that GcMAF produced from all subtypes have high activity
Classic Nagalase theories and new facts
- Alpha-nagalase is an enzyme secreted by cancer cells, virus-infected cells, and normal cells
- 2 types: Exo-type and endo-type Nagalase
- Nagalase has been reported to accumulate in the blood of cancer patients
- Nagalase deglycosylates vitamin D3-binding protein (Gc protein)
- Deglycosylated Gc protein cannot be converted into GcMAF, leading to immunosupression
- However: GcMAF from cancer patients has demonstrated high macrophage phagocytic activity
2 types of Nagalase
- Exo-type and endo-type
- Exo-type nagalase is secreted by: cancer cells, virus-infected cells and normal cells
- Endo-type Nagalase is secreted by: cancer cells and virus-infected cells
- Specific to each disease
- We should use both endo-type and exo-type substrate to measure Nagalase
First Generation GcMAF
- Developed by Dr Yamamoto in 1991
- Low concentration (100 ng/0.25 ml, 1 dose)
- Low stability at room temperature
- 25-(OH) Vitamin D3 Affinity Column
- Unstable in the absence of antioxidants such as albumin and uric acid
Second Generation GcMAF
- Developed by the University of Tokushima and Saisei Mirai in 2010
- High concentration (1500 ng/0.5 ml, 1 dose)
- Significantly higher stability and macrophage activating activity
- New patented production process
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.
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.
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.
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.
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.
We produce GcMAF in our own Saisei Mirai Cell Processing Center (CPC) in Osaka, Japan.
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 is a form of GcMAF produced from bovine colostrum by Saisei Mirai which was developed in collaboration with Tokushima University.
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.
Anyone can take Oral GcMAF to stay healthy and fight off disease.
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.
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
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.
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.
Oral GcMAF is produced in GMP facilities in Japan.
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||Parkinson's disease|
|Autism Spectrum Disorders (ASD)||Herpes Simplex virus (HSV)||Epstein-Barr Virus (EBV)|
|Chronic Fatigue Syndrome (CFS)||Multiple sclerosis (MS)||Cystitis|
|Myalgic Encephalomyelitis (ME)||Rheumatoid arthritis (RA)||Urinary tract infection (UTI)|
|Tuberculosis||Lyme disease (Lyme borreliosis)||Endometriosis|
|Lupus (Systemic lupus erythematosus, SLE)||Mycobacteria infections||Parkinson's disease|
|Malaria||Warts caused by viral infection||Herpes simplex virus (HSV)|
|Q fever (Coxiella burnetii)||Influenza virus (flu)||Chicken pox (varicella zoster virus)|
|Psoriasis||Polycystic ovary syndrome (PCOS)||Ulcerative colitis, Crohn's disease|
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.
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.
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.