Research papers and Presentation papers

Based on a growing body of evidence that a dysregulated innate immune response mediated by monocytes/macrophages plays a key role in the pathogenesis of COVID-19, a clinical trial was conducted to investigate the therapeutic potential and safety of oral macrophage activating factor (MAF) plus standard of care (SoC) in the treatment of hospitalized patients with COVID-19 pneumonia. Ninety-seven hospitalized patients with confirmed COVID-19 pneumonia were treated with oral MAF and a vitamin D3 supplement, in combination with SoC, in a single-arm, open label, multicentre, phase II clinical trial. The primary outcome measure was a reduction in an intensive care unit transfer rate below 13% after MAF administration.


MAF Capsules and M Capsules are dietary supplements produced by Saisei Pharma, Japan. They are designated to modulate the mucosal immunity of the intestine. The main active ingredients of both products are vitamin D binding protein (VDBP) and other glycoproteins which undergo degalactosylation during the process of β-Galactosidase treatment applied to the whole heat-inactivated bovine colostrum in the case of MAF Capsules and to bovine whey in the case of M Capsules. This treatment converts VitD ~ VDBP into VitD-degalactosylated VDBP. The functional activity of degalactosylated VDBP is similar to that seen in the group-specific component macrophage activating factor (GcMAF). GcMAF is a protein that results from the sequential deglycosylation of its precursor – VDBP.  Download pdf

The effects of degalactosylated whey protein on lipopolysaccharide (LPS)-induced inflammatory responses in mice were observed in comparison with intact whey protein. Intraperitoneal administration of both intact and degalactosylated whey proteins for 5 days did not affect body weight and food intake in mice. On day 6, intraperitoneal administration of LPS induced a marked decrease in body weight 4 h later.  Read more >>

Trial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Hospitalized COVID-19 Patients (SaiseiCovUKR) URL :

The hypothesis: Based on the aforementioned findings and on documented analogies between SARS-CoV-2 and HIV, we hypothesized that the reduced conversion activity of the Gc protein (human group-specific component (Gc)) into the macrophage activating factor (MAF) could have a key role in the dysregulate immune response induced by SARS-CoV-2, just like for HIV infected patients. If this hypothesis is correct, it might help to set a valid strategy of immunotherapy also based on an off-label use of GcMAF in critically ill COVID-19 patients.

Conference presentation

Conference presentation - 9th International Congress for Medical Laser Applications, Germany

Conference presentation - The 17th Annual Meeting of The Society of Biotherapeutic Approaches, Fukuoka University

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