Saisei Hawaii USA | Saisei Mirai Group | Immune health food supplements

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3rd Generation GcMAF was developed by Saisei Pharma for which we hold patents. There are fake GcMAF products sold online in Australia by a company which is registered in Hong Kong. Please be aware that 3rd Generation GcMAF products are only produced by Saisei Pharma. Any other products from other companies are fake products.

6-Jan-2021

Clinical trial using MAF for hospitalized COVID-19 patients in Ukraine

In June 2020 we applied to the COVID-19 Scientific Technical Triage of the US FDA for the evaluation of the rationale to study the efficacy of MAF Capsules in COVID-19 treatment. The US FDA in PreIND 151946 meeting response recommended a small proof of concept (POC) study as the initial step prior to the large-scale trial be run. The US FDA indicated recommendations including the major study endpoints addressing the investigation of MAF Capsules efficacy as a potential new drug was implemented in the proposed study design.

The recommended efficacy endpoints were also implemented in the open-label randomized clinical trial that started in Ukraine in November 2020 to assess the efficacy and safety of dietary supplements MAF Capsules, 148 mg and M Capsules, 148 mg in addition to standard of care (SOC) compared with SOC in the treatment of hospitalized non-critical COVID-19 patients.

Summary of preliminary results of clinical study

The ongoing interim study results showed a decrease in all-cause mortality and necessity of oxygen supply, as the mortality was 4/15 in the control group, vs 0/16 and 1/17 of currently enrolled patients in the MAF Capsules and M Capsules groups respectively. The mean duration of supplemental oxygen was 8.5 days in the control group, vs 4.1 and 5.1 days in the MAF Capsules and M Capsules groups respectively.

MAF Capsules, which is under investigational new drug process, is a dietary supplement that targets guts mucosal immunity to modulate macrophages functionality, limiting epithelial damage, and controlling inflammation response during COVID-19.

Clinical trial groups:

Control group
MAF Capsules (colostrum MAF) group
M Capsules (whey MAF) group

Patients randomized 1:1:1 to:

SOC (standard of care)
SOC plus MAF Capsules (148 mg, 3 caps. TID for 14 days)
SOC plus M Capsules (148 mg, 3 caps. TID for 14 days)

As compared to the control, both MAF groups showed a clear trend in decreasing mortality

No adverse events
Decrease in the mortality rate
Decrease in necessity and duration of supplemental oxygen
Decrease in time to recovery
Decrease in time until hospital discharge
Preventing of respiratory failure
Restoring the base-line decreased lymphocytes count

NEWS

Clinical trial to evaluate oral MAF, macrophage activating factor, in the prevention of the COVID-19 associated cytokine storm and the role of macrophages as a front-line innate immunity defense is announced.
A cytokine storm is a type of severe immune overreaction that could result from the novel coronavirus infection and may contribute to acute respiratory disease which has life-threatening complications in patients with COVID-19.

“Our innate immunity can fight off pathogens without causing inflammation and associated respiratory deterioration.”

Macrophage Activating Factor
MAF series

Immune activating MAF series will help boost the immune system by activating immune cells without any side effects. This anti-aging support food is for those who would like to stay young and healthy. The M series is made with natural ingredients and produced in our GMP Certified factory (Certification No. 26518) in Osaka.

Rationales of MAF as a therapeutic target for SARS-CoV-2

The fact that around 96% of patients recover from the infection despite there being no antiviral therapeutics that specifically target human coronaviruses suggests that the human immune system has mechanisms to combat SARS-CoV2.

are approved as food supplements in Ukraine.

“Health Food Products”
Saisei Hawaii

Saisei Pharama’s immune activating food products are very safe and made from natural ingredients.

M-Powder

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M-CAPSULES

Ingredients:

Whey powder, Lactase Enzyme, Microcrystalline cellulose, HPMC capsule

M-Powder

Ingredients:

Whey powder, Dextrin

M-Lollies

Ingredients:

Whey powder, Lactase enzyme, Dextrin, Sugar, Corn syrup, Palm oil, Artificial flavor

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Saisei Mirai Group

We have partnered with 5 domestic clinics in Japan which are based on Saisei Mirai Medical Corporation, bio-venture companies, pharmacies, and universities and medical institutions in Japan and overseas, and have started providing advanced medical care worldwide.