FREQUENTLY ASKED QUESTION (FAQ)

General GcMAF questions

• 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.

A macrophage of a mouse stretching its “arms” (pseudopodia) to engulf two particles, possibly pathogens.

• 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.

• 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).

• Who is Saisei Mirai?ư

  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

• 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 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 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.

• 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.

• 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.

• 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.

• Where do you produce Second Generation GcMAF?

We produce GcMAF in our own Saisei Mirai Cell Processing Center (CPC) in Osaka, Japan.

Oral GcMAF

• 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.

• 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.

• 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

• 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.

• Where is Oral GcMAF produced?

Oral GcMAF is produced in GMP facilities in Japan.

• Who can take Oral GcMAF?

Anyone can take Oral GcMAF to stay healthy and fight off disease.

GcMAF Therapy

• 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.

• 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.

• 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.

• 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 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.

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.

• How long should GcMAF therapy be continued?