Frequently asked questions about Second Generation GcMAF by Saisei Mirai.
General GcMAF questions
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.
A macrophage of a mouse stretching its “arms” (pseudopodia) to engulf two particles, possibly pathogens.
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 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).
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.
Second Generation GcMAF
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 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
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.
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.
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.
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.
We produce GcMAF in our own Saisei Mirai Cell Processing Center (CPC) in Osaka, Japan.
Oral GcMAF is produced in a similar way to Second Generation GcMAF but uses milk protein instead of serum. It is administered orally and sublingually.
See GcMAF Therapy for more details below.
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.
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 our 3rd Generation of GcMAF and is produced from milk proteins by Saisei Mirai which was developed in collaboration with Tokushima University.
Oral GcMAF is produced in GMP facilities in Japan.
Anyone can take Oral GcMAF to stay healthy and fight off disease.
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.
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.
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 administration is typically carried out through subcutaneous (SC) or intramuscular (IM) injections, with a recommended frequency of 2-3 times per week, as directed by the attending physician. The preferred needle size for this procedure is either Size 26G x 1/2″ (0.45 x 13 mm) or Size 27G, along with a 2.5 ml or 1 ml syringe, which should be single-use and sterile disposable. It’s important to highlight that the larger 2.5 ml syringe is often preferred because it reduces the distance the plunger needs to be pushed during the injection, thus improving user-friendliness. In some cases, diabetes needles may also suffice for the administration of GcMAF, although these feature finer needles. Patients should always follow their healthcare provider’s recommendations and guidance regarding the specific administration method and equipment.
Treatment at our clinics often involves intratumoral (IT) injections, although intramuscular (IM) and subcutaneous (SC) injections are the prevailing methods of administration for the majority of our patients. It is imperative to employ a rigorous aseptic technique, which includes the use of pharmaceutical ethanol (ethyl alcohol) for swabbing the vial tops prior to needle insertion when utilizing these vials.
Alternative Methods of Administration:
Oral Administration of Oral MAF via Enteric Capsules
Oral Administration of MAF Products for Enhanced Macrophage Activation
The oral administration of MAF (Macrophage Activation Factor) products, such as Oral MAF powder and MAF candies, presents a unique approach to harnessing the immune-boosting potential within the lymphoid tissue of the mouth and throat. This tissue is rich in macrophages, immune cells that play a pivotal role in defending the body against infections and foreign agents.
When we employ the use of Oral MAF powder and Oral MAF Capsules (by opening the capsules), the macrophages within the mouth and throat can be effectively activated. This activation is achieved by allowing the powder to rest in the mouth for a period of 15-20 minutes or longer. Alternatively, macrophage activation can also be stimulated by consuming MAF candies.
While there is the possibility of sublingual absorption of some GcMAF through the blood vessels in the mouth, the primary method of activation is believed to occur within the lymphoid tissue of the throat. This lymphoid tissue is a vital component of the immune system, crucial for mounting immune responses and safeguarding the body against infections and foreign invaders.
This method of administration holds particular promise for individuals with deficiencies in Immunoglobulin A (IgA) and Immunoglobulin M (IgM), as it offers a targeted approach to bolstering their immune defenses. By leveraging the lymphoid tissue’s innate capacity for macrophage activation, Oral MAF products can contribute to improving immune function and overall health.
Inhalation via Nebulization:
|Omron NE-U22 Portable Nebuliser for administration in the lungs to activate macrophages in the Bronchus-Associated Lymphoid Tissue (BALT) of the lungs.|
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.
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.
GcMAF and/or oral MAF immunotherapy are recommended for the management of conditions characterized by immune dysfunction or compromised immune systems, including but not limited to:
|Cancer||Autoimmune diseases||Respiratory tract infections|
|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.
GcMAF can be safely used with a wide variety of drugs and other treatments.
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.
Ordering and Shipping
If you wish to order Second/Third Generation GcMAF Therapy made by Saisei Mirai, please click here.
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.
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.
Shipping and handling cost 9,000 yen or more worldwide. Prices include shipping and handling costs. Shipping can be calculated for other couriers such as Fedex or EMS.
Import duties, taxes and charges are not included in the item price or shipping charges. These charges are the buyer’s responsibility. Please check with your country’s customs office.