Research papers and Presentation papers | Saisei Immunotherapy Clinics

Effect of degalactosylated bovine glycoprotein formulations MAF and M сapsules on lymphopenia and clinical outcomes in hospitalized Covid-19 patients: a randomized clinical trial

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.

US National Library of Medicine, NIH clinical trial

Trial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Hospitalized COVID-19 Patients (SaiseiCovUKR) URL : https://clinicaltrials.gov/ct2/show/NCT04762628

The clinical trial using MAF 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. (PDF)

Potential role of GcMAF in suppressing the severity of COVID-19-induced immune responses: Lesson learned from HIV

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)

[Sonodynamic and Photodynamic Therapy in Advanced Breast Carcinoma]

[Activated Cancer Therapy Using Light and Ultrasound – A Case Series of
Sonodynamic Photodynamic Therapy in 115 Patients over a 4 Year Period]

[Objective Outcome Measures Following Sonodynamic Photodynamic Therapy]

Degalactosylated/Desialylated Bovine Colostrum Induces Macrophage Phagocytic Activity Independently of Inflammatory Cytokine Production

Evaluation of the Sonosensitizing Activities of 5-Aminolevulinic Acid and Sn(IV) Chlorin e6 in Tumor-bearing Chick Embryos

Clinical Experience of Integrative Cancer Immunotherapy

Degalactosylated/Desialylated Human Serum Containing GcMAF Induces Macrophage Phagocytic Activity and In Vivo Antitumor Activity

GcMAF : our next generation immunotherapy

Clinical Experience of Integrative Cancer Immunotherapy

Degalactosylated/Desialylated Human Serum Containing GcMAF Induces Macrophage Phagocytic Activity and In Vivo Antitumor Activity

Evaluation of the Sonosensitizing Activities of 5-Aminolevulinic Acid and Sn(IV) Chlorin e6 in Tumor-bearing Chick Embryos

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.