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 >>
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.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7513798/
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Research paper
2016 Case Report: GcMAF Treatment in a Patient with Multiple Sclerosis (PDF)
ANTICANCER RESEARCH 36: 3771-3774 (2016)
About the Sonodynamic and Photodynamic Therapy (3 papers)
Conference presentation
Conference presentation - 9th International Congress for Medical Laser Applications, Germany
29-JUN-2014
Indications for GcMAF for immunotherapy of cancers and chronic viral and bacterial infections (PDF) Dr. Toshio Inui
Conference presentation - The 17th Annual Meeting of The Society of Biotherapeutic Approaches, Fukuoka University
7-DEC-2013
Case Report: A Breast Cancer Patient Treated with GcMAF, Sonodynamic Therapy and Hormone Therapy (PDF), PPT Dr. Toshio Inui
Our research group
- Professor Hitoshi Hori, Institute of Technology and Science, The University of Tokushima, Tokushima, Japan.
- Associate professor, Yoshihiro Uto, Institute of Technology and Science, The University of Tokushima, Tokushima, Japan.
- Professor Norihiro Sakamoto, National University Hospital, Kobe University School of Medicine, Kobe, Japan.
- Professor Yoshinori Marunaka, Kyoto Prefectural University of Medicine, Kyoto, Japan.
- Professor Yoshito Nishikata, Faculty of Science, Konan University, Kobe, Japan.
- Kentaro Kubo, PhD., Saisei Mirai Cell Processing Center, Osaka, Japan.