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1.
BMC Infect Dis ; 24(1): 519, 2024 May 23.
Artigo em Inglês | MEDLINE | ID: mdl-38783176

RESUMO

BACKGROUND: Targeting mucosal immunity of the gut, which is known to provide antigen processing, while avoiding excessive or unnecessary inflammation, was tested as a way to modulate COVID-19 severity. METHODS: Randomized open-label trial in 204 adults hospitalized with non-critical COVID-19 who received for 14 days in addition to standard of care (SOC) degalactosylated bovine glycoproteins formulations of either MAF capsules (MAF group) or M capsules (M group) or SOC only (control group). RESULTS: Median recovery time when patients did not require supplemental oxygen was 6 days in both study groups compared to 9 days in the control (MAF vs. control; P = 0.020 and M vs. control; P = 0.004). A greater reduction in mortality was seen in the MAF group compared to the control by day 14 (8.3% vs. 1.6%; P = 0.121) and by day 29 (15.3% vs. 3.2%; P = 0.020), and similarly in the M group by day 14 (8.3% vs. 2.9%; P = 0.276) and by day 29 (15.3% vs. 2.9%; P = 0.017). The proportion of those who had baseline absolute lymphocyte count (ALC) lower than 0.8 × 109/L was 13/63 (20.6%), 17/69 (24.6%), and 18/72 (25.0%) of patients in MAF, M, and control group respectively. Day 29 mortality among these lymphopenic patients was three times higher than for the intent-to-treat population (21% vs. 7%) and consisted in above subgroups: 2/13 (15%), 2/17 (12%), and 6/18 (33%) of patients. The decreased mortality in both study subgroups correlated with greater ALC restoration above 0.8 × 109/L level seen on day 14 in 91% (11/12) and 87.5% (14/16) of survivors in MAF and M subgroups respectively compared to 53.3% (8/15) of survivors in control subgroup. Incidences of any ALC decrease below the baseline level on day 14 occurred in 25.4% of patients in the MAF group and 29.0% of patients in the M group compared to 45.8% in control and ALC depletion by ≥ 50% from the baseline level consisted of 7.9%, 5.8%, and 15.3% of cases in these groups respectively. CONCLUSION: This study showed that both study agents prevented ALC depletion and accelerated its restoration, which is believed to be one of the mechanisms of improved crucial clinical outcomes in hospitalized COVID-19 patients. TRIAL REGISTRATION: The trial was registered after the trial start in ClinicalTrials.gov NCT04762628, registered 21/02/2021, https://www. CLINICALTRIALS: gov/ct2/show/NCT04762628 .


Assuntos
COVID-19 , Glicoproteínas , Linfopenia , SARS-CoV-2 , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , COVID-19/mortalidade , COVID-19/imunologia , COVID-19/terapia , SARS-CoV-2/imunologia , Idoso , Glicoproteínas/imunologia , Glicoproteínas/uso terapêutico , Resultado do Tratamento , Tratamento Farmacológico da COVID-19 , Bovinos , Animais , Adulto , Hospitalização/estatística & dados numéricos , Cápsulas
2.
Biomed Pharmacother ; 169: 115894, 2023 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-37988850

RESUMO

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. At the end of the study, an additional propensity score matching (PSM) analysis was performed to compare the MAF group with a control group treated with SoC alone. Out of 97 patients treated with MAF, none needed care in the ICU and/or intubation with mechanical ventilation or died during hospitalization. Oxygen therapy was discontinued after a median of nine days of MAF treatment. The median length of viral shedding and hospital stay was 14 days and 18 days, respectively. After PSM, statistically significant differences were found in all of the in-hospital outcomes between the two groups. No mild to serious adverse events were recorded during the study. Notwithstanding the limitations of a single-arm study, which prevented definitive conclusions, a 21-day course of MAF treatment plus SoC was found to be safe and promising in the treatment of hospitalized adult patients with COVID-19 pneumonia. Further research will be needed to confirm these preliminary findings.


Assuntos
COVID-19 , Adulto , Humanos , Progressão da Doença , Hospitalização , Tempo de Internação , Estudos Prospectivos , SARS-CoV-2 , Resultado do Tratamento
3.
Anticancer Res ; 36(7): 3771-4, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27354653

RESUMO

BACKGROUND/AIM: Gc protein-derived macrophage-activating factor (GcMAF) has various functions as an immune modulator, such as macrophage activation, anti-angiogenic activity and anti-tumor activity. Clinical trials of second-generation GcMAF demonstrated remarkable clinical effects in several types of cancers. Thus, GcMAF-based immunotherapy has a wide application for use in the treatment of many diseases via macrophage activation that can be used as a supportive therapy. Multiple sclerosis (MS) is considered to be an autoimmune disorder that affects the myelinated axons in the central nervous system (CNS). This study was undertaken to examine the effects of second-generation GcMAF in a patient with MS. RESULTS: This case study demonstrated that treatments of GcMAF in a patient with MS have potent therapeutic actions with early beneficial responses, especially improvement of motor dysfunction. CONCLUSION: GcMAF shows therapeutic potency in the treatment of MS.


Assuntos
Fatores Imunológicos/uso terapêutico , Fatores Ativadores de Macrófagos/uso terapêutico , Esclerose Múltipla/tratamento farmacológico , Proteína de Ligação a Vitamina D/uso terapêutico , Idoso , Humanos , Fatores Imunológicos/farmacologia , Imunoterapia , Locomoção/efeitos dos fármacos , Fatores Ativadores de Macrófagos/farmacologia , Masculino , Esclerose Múltipla/fisiopatologia , Indução de Remissão , Resultado do Tratamento , Proteína de Ligação a Vitamina D/farmacologia
4.
Anticancer Res ; 36(7): 3767-70, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27354652

RESUMO

BACKGROUND/AIM: Macrophage activating factor (MAF)-based immunotherapy has a wide application for use in treating many diseases via macrophage activation. Sonodynamic therapy (SDT) using low-intensity ultrasound and tumor treating field (TTF) therapy are novel therapeutic modalities. SDT is usually combined with ozone therapy to improve local hypoxia within the tumor environment. CASE REPORT: We treated a 77-year-old male diagnosed with non-small cell lung cancer ((NSCLC) stage 3B) using second-generation serum GcMAF and oral colostrum MAF-based immunotherapy combined with SDT, TTF and ozone therapies. RESULTS: This case report demonstrates that GcMAF, oral colostrum MAF, SDT, TTF and ozone therapy can be used for NSCLC without adverse effects. CONCLUSION: This case report suggests a new concept of cancer treatment using local destruction of cancer tissue, in this case conducted with SDT and TTF therapy, to be used in combination with serum GcMAF and colostrum MAF immunotherapy as a systemic treatment.


Assuntos
Adenocarcinoma/diagnóstico por imagem , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/diagnóstico por imagem , Neoplasias Pulmonares/diagnóstico por imagem , Adenocarcinoma/tratamento farmacológico , Adenocarcinoma/patologia , Idoso , Carboplatina/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/patologia , Terapia Combinada , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/patologia , Fatores Ativadores de Macrófagos/administração & dosagem , Masculino , Pemetrexede/administração & dosagem , Resultado do Tratamento , Terapia por Ultrassom , Proteína de Ligação a Vitamina D/administração & dosagem , Gencitabina
5.
Anticancer Res ; 35(8): 4545-9, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26168499

RESUMO

BACKGROUND: Gc protein-derived macrophage-activating factor (GcMAF) immunotherapy has been steadily advancing over the last two decades. Oral colostrum macrophage-activating factor (MAF) produced from bovine colostrum has shown high macrophage phagocytic activity. GcMAF-based immunotherapy has a wide application for use in treating many diseases via macrophage activation or for use as supportive therapy. RESULTS: Three case studies demonstrate that oral colostrum MAF can be used for serious infection and chronic fatigue syndrome (CFS) without adverse effects. CONCLUSION: We demonstrate that colostrum MAF shows promising clinical results in patients with infectious diseases and for symptoms of fatigue, which is common in many chronic diseases.


Assuntos
Colostro/imunologia , Síndrome de Fadiga Crônica/terapia , Imunoterapia/métodos , Infecções/terapia , Fatores Ativadores de Macrófagos/uso terapêutico , Neoplasias/complicações , Proteína de Ligação a Vitamina D/uso terapêutico , Idoso , Doença Catastrófica/terapia , Síndrome de Fadiga Crônica/etiologia , Feminino , Febre/tratamento farmacológico , Humanos , Infecções/etiologia , Ativação de Macrófagos/efeitos dos fármacos , Macrófagos/efeitos dos fármacos , Macrófagos/imunologia , Pessoa de Meia-Idade , Gravidez
6.
Anticancer Res ; 35(8): 4487-92, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26168491

RESUMO

BACKGROUND/AIM: Colostrum contains antibodies, such as immunoglobulin G (IgG), immunoglobulin A (IgA) and immunoglobulin M (IgM), and, therefore, has potent immunomodulating activity. In particular, IgA has an O-linked sugar chain similar to that in the group-specific component (Gc) protein, a precursor of the Gc protein-derived macrophage-activating factor (GcMAF). In the present study, we investigated the macrophage-activating effects of degalactosylated/desialylated bovine colostrum. RESULTS: We detected the positive band in degalactosylated/ desialylated bovine colostrum by western blotting using Helix pomatia agglutinin lectin. We also found that degalactosylated/ desialylated bovine colostrum could significantly enhance the phagocytic activity of mouse peritoneal macrophages in vitro and of intestinal macrophages in vivo. Besides, degalactosylated/desialylated bovine colostrum did not mediate the production of inflammatory cytokines such as tumor necrosis factor-α (TNF-α) and interleukin-1ß (IL-1ß). CONCLUSION: Similar to the use of GcMAF, degalactosylated/desialylated bovine colostrum can be used as a potential macrophage activator for various immunotherapies.


Assuntos
Colostro/imunologia , Imunomodulação , Interleucina-1beta/biossíntese , Ativação de Macrófagos/imunologia , Macrófagos Peritoneais/imunologia , Fator de Necrose Tumoral alfa/biossíntese , Animais , Bovinos , Feminino , Imunoglobulina A/imunologia , Imunoglobulina G/imunologia , Imunoglobulina M/imunologia , Lectinas/imunologia , Fatores Ativadores de Macrófagos/imunologia , Camundongos , Camundongos Endogâmicos C57BL , Fagocitose , Gravidez , Proteína de Ligação a Vitamina D/imunologia
7.
Anticancer Res ; 34(8): 4589-93, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25075104

RESUMO

BACKGROUND: Gc protein-derived macrophage-activating factor (GcMAF) occurs naturally in the human body. It has various functions, such as macrophage activation and antitumor activities. Recently, immunotherapy has become an attractive new strategy in the treatment of cancer. GcMAF-based immunotherapy can be combined with many other therapies. Sonodynamic therapy (SDT) using low-intensity ultrasound is a novel therapeutic modality. Ultrasound has been demonstrated to activate a number of sonosensitive agents allowing for the possibility of non-invasive targeted treatment for both superficial and deep-seated tumors. The current case study demonstrates that GcMAF and SDT can be used in combination with conventional therapies in patients with metastatic cancer, especially where treatment options are limited due to factors such as toxicity. This case study also suggests a new concept of cancer treatment using local destruction of cancer tissue, in this case conducted with SDT, to be used in combination with GcMAF immunotherapy as a systemic treatment.


Assuntos
Androstadienos/uso terapêutico , Neoplasias da Mama/terapia , Fatores Ativadores de Macrófagos/uso terapêutico , Terapia por Ultrassom/métodos , Proteína de Ligação a Vitamina D/uso terapêutico , Terapia Combinada , Feminino , Humanos , Pessoa de Meia-Idade
8.
Anticancer Res ; 33(7): 2917-9, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23780980

RESUMO

BACKGROUND: Immunotherapy has become an attractive new strategy in the treatment of cancer. The laboratory and clinical study of cancer immunotherapy is rapidly advancing. However, in the clinical setting, the results of cancer immunotherapy are mixed. We therefore contend that cancer immunotherapy should be customized to each patient individually based on their immune status and propose an integrative immunotherapy approach with second-generation group-specific component macrophage activating factor (GcMAF)-containing human serum. PATIENTS AND METHODS: The standard protocol of our integrative cancer immunotherapy is as follows: i) 0.5 ml GcMAF-containing human serum is administered intramuscularly or subcutaneously once or twice per week for the duration of cancer therapy until all cancer cells are eradicated; ii) hyper T/natural killer (NK) cell therapy is given once per week for six weeks; iii) high-dose vitamin C is administered intravenously twice per week; iv) alpha lipoic acid (600 mg) is administered orally daily; v) vitamin D3 (5,000-10,000 IU) is administered orally daily. RESULTS: By March 2013, Saisei Mirai have treated over 345 patients with GcMAF. Among them we here present the cases of three patients for whom our integrative immunotherapy was remarkably effective. CONCLUSION: The results of our integrative immunotherapy seem hopeful. We also plan to conduct a comparative clinical study.>


Assuntos
Neoplasias Ósseas/terapia , Imunoterapia , Neoplasias Hepáticas/terapia , Neoplasias Pulmonares/terapia , Fatores Ativadores de Macrófagos/administração & dosagem , Neoplasias da Próstata/terapia , Neoplasias do Timo/terapia , Proteína de Ligação a Vitamina D/administração & dosagem , Idoso , Ácido Ascórbico/administração & dosagem , Neoplasias Ósseas/imunologia , Neoplasias Ósseas/secundário , Terapia Baseada em Transplante de Células e Tecidos , Terapia Combinada , Feminino , Humanos , Injeções Intramusculares , Injeções Subcutâneas , Neoplasias Hepáticas/imunologia , Neoplasias Hepáticas/patologia , Neoplasias Pulmonares/imunologia , Neoplasias Pulmonares/secundário , Masculino , Prognóstico , Neoplasias da Próstata/imunologia , Neoplasias da Próstata/patologia , Ácido Tióctico/administração & dosagem , Neoplasias do Timo/imunologia , Neoplasias do Timo/patologia
9.
Anticancer Res ; 33(7): 2881-5, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23780974

RESUMO

BACKGROUND: The group-specific component protein-derived macrophage-activating factor (GcMAF) has various biological activities, such as macrophage activation and antitumor activity. Clinical trials of GcMAF have been carried out for metastatic breast cancer, prostate cancer, and metastatic colorectal cancer. In this study, despite the complicated purification process of GcMAF, we used enzymatically-treated human serum containing GcMAF with a considerable macrophage-stimulating activity and antitumor activity. RESULTS: We detected GcMAF in degalactosylated/desialylated human serum by western blotting using an anti-human Gc globulin antibody, and Helix pomatia agglutinin lectin. We also found that GcMAF-containing human serum significantly enhanced the phagocytic activity of mouse peritoneal macrophages and extended the survival time of mice bearing Ehrlich ascites tumors. CONCLUSION: We demonstrated that GcMAF-containing human serum can be used as a potential macrophage activator for cancer immunotherapy.


Assuntos
Carcinoma de Ehrlich/prevenção & controle , Galactose/metabolismo , Ativação de Macrófagos/efeitos dos fármacos , Fatores Ativadores de Macrófagos/farmacologia , Macrófagos Peritoneais/efeitos dos fármacos , Fagocitose/efeitos dos fármacos , Soro/química , Ácidos Siálicos/metabolismo , Proteína de Ligação a Vitamina D/farmacologia , Animais , Western Blotting , Carcinoma de Ehrlich/metabolismo , Carcinoma de Ehrlich/patologia , Feminino , Humanos , Macrófagos Peritoneais/citologia , Macrófagos Peritoneais/metabolismo , Camundongos , Camundongos Endogâmicos ICR
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