Second Generation GcMAF
Second Generation Gc-MAF is produced using a new Patented 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 20 years. Our GcMAF is made in our sterile cell processing facility using this new and improved 2nd generation method which is 10-15 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 have 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
- 0.5ml of High Dose GcMAF (Saisei Mirai 2nd Generation GcMAF) is approximately 1500ng GcMAF.
- 0.5ml of High Dose GcMAF (1st Generation GcMAF) is approximately 1500ng 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
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.
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. 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.
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
- Infectious diseases, including antibiotics resistant bacteria and Covid-19
- Autism spectrum disorder (ASD)
- Chronic fatigue syndrome (CFS)
- Atopic dermatitis
- Hair loss
- Multiple sclerosis
- Pollinosis
- Autoimmune diseases
- Injuries
- Epilepsy
- Brain degenerative diseases
- Rejuvenation and Longevity
- 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:
- Radiation therapy is preferred over chemotherapy, if possible.
Treatment
- Treatment is by intramuscular (IM) or subcutaneous (SC) injection of GcMAF macrophage activating factor, 3-7 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:
GcMAF immunotherapy protocol for Cancer
New Generation GcMAF Protocol for Cancer
1. Optimal results can be achieved by combining Serum GcMAF injections with Dietary
GcMAF (available in capsules, powder, or candy).
2. GcMAF injections are administered subcutaneously or intramuscularly, preferably in
proximity to the tumors.
3. Updated as of November 11th, 2022, the dosage recommendations for Serum GcMAF
are as follows:
i) For cancer prevention: 1 ml GcMAF injection, typically once a week.
ii) For stage 1 cancer: 1 ml GcMAF injection, generally administered 1-2 times a week.
iii) For stage 2 cancer: 1 ml GcMAF injection, usually 2-3 times a week.
iv) For stage 3 cancer: 1 ml GcMAF injection, typically 3 times a week.
v) For stage 4 cancer: 1 ml GcMAF injection, usually 3-5 times a week.
AND/OR
4. Dietary GcMAF
Dietary GcMAF is beneficial for patients with poor nutrition and cancer cachexia, as it
improves appetite, boosts energy levels, and reduces fatigue. Dietary GcMAF is typically
taken orally.
5. Dosage recommendations for Dietary GcMAF (MAF Capsules Triple or MAF
Capsules):
■ MAF Triple
1. For Adults: 2 capsules per day, one in the morning 20 minutes before breakfast,
and one before bedtime.
2. For Children (20 kg): 1 capsule per day, either in the morning 20 minutes before
breakfast or before bedtime.
3. For cancer cachexia: 2-3 capsules per day, taken 1 capsule 2-3 times before
meals.
■ MAF Capsules
1. For Adults: 4 capsules per day, with 2 capsules in the morning 20 minutes before
breakfast and 2 capsules before bedtime.
2. For Children (20 kg): 2 capsules per day, with 1 capsule in the morning 20
minutes before breakfast and 1 capsule before bedtime.
3. For Cancer cachexia: 6-8 capsules per day, with 2 capsules taken 3-4 times
before meals.
Please store the vials in the freezer. Keep only the vial you are using in the fridge.
Freezing helps preserve the activity for an extended period and prevents the settling of
certain solid components in the GcMAF serum, which can occur after a few weeks to
months of storage in the fridge.
Stability tests have shown that Serum GcMAF is highly temperature-stable and
maintains maximum activity even after 4 weeks at room temperature and 1 week at 40
°C (104 °F). Shipping does not impact the product's activity. For laboratory data, please
consult our Stability of GcMAF Experiment Report on our website.
Furthermore, we recommend considering the combination of other therapies such as
Tumor Treating Field (TTF) and/or High Dose Vitamin C infusion alongside GcMAF for
improved results.
You can find more information here
Hepatitis, Tuberculosis:
For Hepatitis, Tuberculosis we suggest.
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. *
- Many patients start with Oral GcMAF (3rd Generation GcMAF), Capsules, or Powder. Below is Dr. Heather Way’s protocol.
- 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
Get Second/Third Generation GcMAF Therapy
Patients and doctors can order Second/Third Generation GcMAF Therapy made by Saisei Mirai from our official Saisei Mirai online shop, or oral MAF series products from our Saisei Pharma online shop.
High Dose GcMAF 2.5 ml multi-dose vials (1500 ng/0.5 ml):
- 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.
- Shipping and handling fee is from 18,000 JPY by FedEx.
- Please keep the vials in the freezer. Only the vial you are using is kept in the fridge.
When frozen, it helps preserve activity for a very long time and prevents the settling of some solid parts in the GcMAF serum, which may start to occur with a few weeks to months of sitting in the fridge.
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.
- Please keep the vials in the freezer. Only the vial you are using is kept in the fridge.
- Please contact us for pricing.
Information
If you wish to order Second/Third Generation GcMAF Therapy made by Saisei Mirai, please visit our official Saisei Mirai online shop, or for oral MAF series products, our Saisei Pharma online shop.
- 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 FedEx 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 below for the tests 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 Freezer 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.
However, we recommend keeping the vials in the freezer
Shipping Notes
We use special packaging and ice 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 Second Generation GcMAF 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 or frozen for longer term storage. Any vials being used should be kept refrigerated.
Tests of Second Generation GcMAF
Please refer to our Tests of Second Generation GcMAF page for detailed information.
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)
- Hepatitis B surface antigen (HBsAg)
- Hepatitis B core antibody (HBcAb)
- Hepatitis B e antigen (HBeAg)
- Hepatitis C virus (HCV) antibody
- HIV antigen and antibody
- Human T-cell lymphotropic virus (HTLV1) antibody
- 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.
- We recommend keeping the vials in the freezer.
Research Papers and Presentations
Please refer to our research papers and presentations page for detailed information.
