Saisei Mirai Clinics

CLINICAL STUDY MAF capsules efficacy in post-COVID syndrome treatment is started in KAZAKHSTAN

MedInc Ltd in Kazakhstan on the base of National Research Cardiac Surgery Center has started the implementation of prospective randomized open-label clinical trial: “Evaluation of immune modulator MAF capsules efficacy in a therapy of patients with post-COVID syndrome”. The study sponsored by the developer and manufacturer of the study product Saisei Pharma Co. Ltd, Japan.

The goal of the study is the evaluation of the safety and efficiency of a MAF capsules dietary supplement with anti-inflammatory immune response modulating function in combined treatment of the post-COVID syndrome. |

The trial started in February 2021 and targeted 200 patients with post-COVID syndrome, which will be randomized 1:1 in two groups:
Group 1: SOC (standard of care) + dietary supplement MAF capsules administration for 30 days.
Group 2: SOC

The study primary endpoints aim to evaluate the improvement within 30 days period after MAF capsules administration, where the clinical efficacy refers to an improvement of life quality according to Chalder Fatigue Scale and the “Postcovid syndrome” consequences and symptoms severity evaluation according to ISARIC questionnaire.

The study secondary endpoints included the evaluation of changes according to the Karnofsky Performance Scale and Numerical Rating Scale, and evaluation of the MAF capsules side effects.

The exploratory endpoints include effects on:
1. Lymphocyte count, T cells and its subpopulation count, and B cells count
2. The plasma level of IgG against SARS-CoV-2

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

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

04-Mar-2021

The clinical trial using MAF capsules has started in Kazakhstan for the patients suffering with coronavirus aftereffects in February 2021.

28-Feb-2021

Update on the clinical trial using MAF for hospitalized COVID-19 patients in Ukraine.

30-Nov-2020

The clinical trial using MAF capsules has started in Italy from November for hospitalised patients with COVID-19.

11-Nov-2020 – Saisei Pharma Announcement

The clinical trial using MAF capsules has started in Ukraine from the end of October for hospitalised patients with COVID-19.

11-Nov-2020 – Saisei Pharma Announcement

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.

30-Nov-2020

News

2021.01.06 　Update on the clinical trial using MAF for hospitalized COVID-19 patients in Ukraine

Update on the clinical trial using MAF for hospitalized COVID-19 patients in Ukraine

check our research papers

2020.11.30 　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/

Conclusion: According to the provided literature overview, we firmly believe that GcMAF deserves be tested as immune-therapeutic to increase macrophages functionality for earlier SARS-CoV-2 viral control, protection against COVID-19 progression by limiting epithelial damage, control local inflammation and prevent from the hyperinflammatory immune response. For this purpose, we planned a Phase-II interventional clinical trial evaluating the effectiveness and safety of Oral immunotherapy with Third Generation GcMAF in hospitalized patients with COVID-19 pneumonia (COral-MAF1 Trial) at the “Ospedale del Mare” Hospital, Naples, Italy.

2020.11.07 　New Year Clinic closure dates

Keihan Clinic, Kobe Clinic and Science Clinic Cancer treatments, Science Clinic Skin Beauty treatments will be closed from Wednesday 30th December 2020 until Monday 4th January 2021.
We will reopen for business in the new year on Tuesday 5th January 2021.

2020.05.07 　Saisei Pharma plans clinical study of oral MAF in COVID-19 patients

Saisei Pharma plans clinical study of oral MAF in COVID-19 patients details were featured on some website.
Please check the below URL.

finanzen.ch
advfn.com
chestnutpost.com
benzinga.com

2018.11.01 　Announcement of partnership with Ukrainian National Cancer Center

This time, the Saisei Mirai, has contracted official partnership with the Ukrainian National Cancer Center as partner hospitals.

National Cancer Institute of Health Ukraine

2018.10.27 　True Facts about First Immune

Please check the link below.

https://www.bbc.com/news/health-34326801