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Article: IV. Two variants of biological response modifier glucans (BRMG) in Covid-19 pilot study; Follow-up summary.

Raghavan, Kadalraja

Journal of stem cells & regenerative medicine

2021 Volume 17, Issue 2, Page(s) 67

Language	English
Publishing date	2021-12-30
Publishing country	India
Document type	Journal Article
ZDB-ID	2587301-5
ISSN	0973-7154
ISSN	0973-7154
DOI	10.46582/jsrm.1702011
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Article ; Online: Qualitative Evaluation of α-Synuclein: A Critical Step in Unravelling the Complexities of Autism Spectrum Disorder.

Preethy, Senthilkumar / Raghavan, Kadalraja / Ikewaki, Nobunao / Abraham, Samuel J K

Medical principles and practice : international journal of the Kuwait University, Health Science Centre

2022 Volume 32, Issue 1, Page(s) 96–97

MeSH term(s)	Humans ; Autism Spectrum Disorder ; alpha-Synuclein ; Qualitative Research
Chemical Substances	alpha-Synuclein
Language	English
Publishing date	2022-10-29
Publishing country	Switzerland
Document type	Letter ; Comment
ZDB-ID	645108-1
ISSN	1423-0151 ; 1011-7571
ISSN (online)	1423-0151
ISSN	1011-7571
DOI	10.1159/000527728
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Article ; Online: Integrating the Synergy of the Gut Microbiome into Regenerative Medicine: Relevance to Neurological Disorders.

Preethy, Senthilkumar / Ranganathan, Natarajan / Raghavan, Kadalraja / Dedeepiya, Vidyasagar Devaprasad / Ikewaki, Nobunao / Abraham, Samuel J K

Journal of Alzheimer's disease : JAD

2022 Volume 87, Issue 4, Page(s) 1451–1460

Abstract: A new paradigm of cell therapy-based approaches as a solution to several diseases caused by damage or loss of cells/tissues leading to organ failure heralded the birth of a new branch in medicine called regenerative medicine (RM), which was further ... ...

Abstract	A new paradigm of cell therapy-based approaches as a solution to several diseases caused by damage or loss of cells/tissues leading to organ failure heralded the birth of a new branch in medicine called regenerative medicine (RM), which was further fueled by in vitro cell expansion and tissue engineering (TE) technologies, including the ability to grow embryonic stem cells, induce pluripotent stem cells, and so on. RM addresses organ failure by repair, regeneration, or restoration, rejuvenation using cells, stem cells, or progenitor cells as tools having added cell-derived products also as a tool, and extracellular matrix component-based support, either direct or indirect (e.g., matrix induced autologous chondrocyte implantation) using scaffolds. Now, the main objective of RM is to solve the functional loss of cells that have evolved from cells as tools to cell-derived factors and scaffolds per se as tools. In this context, an important yet indispensable group of cells that constitute the major portion of the human body in terms of the number of cells having several essential roles to play, both directly and indirectly, starting from digestion and the immune system to the growing evidence of influencing neuronal function, aging, and carcinogenesis has been ignored. We would like to focus on these in this review as they should essentially be considered as a tool of RM, especially for neurological disorders for their vital role. What we are indicating is the second genome or the gut microbiome.
MeSH term(s)	Gastrointestinal Microbiome ; Humans ; Nervous System Diseases/therapy ; Regenerative Medicine ; Stem Cells ; Tissue Engineering
Language	English
Publishing date	2022-05-25
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	1440127-7
ISSN	1875-8908 ; 1387-2877
ISSN (online)	1875-8908
ISSN	1387-2877
DOI	10.3233/JAD-220313
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Article ; Online: Efficacy of N-163 beta-glucan in beneficially improving biomarkers of relevance to muscle function in patients with muscular dystrophies in a pilot clinical study.

Raghavan, Kadalraja / Sivakumar, Thanasekar / Ichiyama, Koji / Yamamoto, Naoki / Balamurugan, Mangaleswaran / Dedeepiya, Vidyasagar Devaprasad / Senthilkumar, Rajappa / Preethy, Senthilkumar / Abraham, Samuel Jk

Acta myologica : myopathies and cardiomyopathies : official journal of the Mediterranean Society of Myology

2023 Volume 42, Issue 4, Page(s) 129–134

Abstract: Background: Muscular dystrophies other than Duchenne muscular dystrophy (DMD) are genetic diseases characterized by increasing muscle weakness, loss of ambulation, and ultimately cardiac and respiratory failure. There are currently no effective ... ...

Abstract	Background: Muscular dystrophies other than Duchenne muscular dystrophy (DMD) are genetic diseases characterized by increasing muscle weakness, loss of ambulation, and ultimately cardiac and respiratory failure. There are currently no effective therapeutics available. Having demonstrated the efficacy of a N-163 strain of Aureobasidium Pullulans (Neu-REFIX) produced B-1, 3-1,6-Glucan in pre-clinical and clinical studies of Duchenne muscular dystrophy (DMD) earlier, we assessed the effectiveness of this novel Beta glucan in the other muscular dystrophies in the present study. Methods: In this 60-day study, six patients with muscular dystrophies other than DMD consumed one 8g gel of Neu-REFIX beta-glucan along with their usual standard of care treatment regimen, and their biomarkers of relevance to muscle function such as serum calcium (SC), creatine phosphokinase (CPK), and alkaline phosphatase (ALP) levels along with functional improvement criteria, which is, Medical research council (MRC) scale and North Star Ambulatory assessment (NSAA), assessed at baseline and following the intervention. Results: After the intervention, the SC levels significantly decreased from a mean baseline value of 9.28 mg/dL to 8.31 mg/dL (p-value = 0.02). With a p-value of 0.29, the mean CPK value dropped from 2192.33 IU/L to 1567.5 IU/L. Following the intervention, the ALP levels dropped from 200.33 to 75.5 U/L (p-value = 0.15). MRC scale improved in three out of six patients. NSAA remained stable. There were no adverse effects. Conclusion: This study has proven the safety of Neu REFIX beta-glucan food supplement and its efficacy in improving both plasma biomarkers and functional parameters of muscle in a short duration of 2 months. Further validation by evaluation of muscle function for a longer duration is recommended to confirm the efficacy of Neu-REFIX food supplement as a potential adjuvant DMT in muscular dystrophies.
MeSH term(s)	Humans ; Muscular Dystrophy, Duchenne/genetics ; beta-Glucans ; Biomarkers ; Muscles ; Muscle Weakness
Chemical Substances	beta-Glucans ; Biomarkers
Language	English
Publishing date	2023-12-20
Publishing country	Italy
Document type	Case Reports
ZDB-ID	2102328-1
ISSN	2532-1900 ; 1128-2460
ISSN (online)	2532-1900
ISSN	1128-2460
DOI	10.36185/2532-1900-312
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Article ; Online: Re-examination of therapeutic management of muscular dystrophies using a vascular smooth muscle-centered approach.

Preethy, Senthilkumar / Yamamoto, Naoki / Osaza, Shiro / Raghavan, Kadalraja / Dedeepiya, Vidyasagar Devaprasad / Iwasaki, Masaru / Abraham, Samuel Jk

Journal of smooth muscle research = Nihon Heikatsukin Gakkai kikanshi

2023 Volume 59, Page(s) 67–80

Abstract: In contrast to the long-standing focus on the pathophysiology of skeletal muscles in the hunt for a cure for Duchenne muscular dystrophy (DMD), we opine that the malfunctioning of dystrophin produced by vascular smooth muscle is a major contributor to ... ...

Abstract	In contrast to the long-standing focus on the pathophysiology of skeletal muscles in the hunt for a cure for Duchenne muscular dystrophy (DMD), we opine that the malfunctioning of dystrophin produced by vascular smooth muscle is a major contributor to the pathology of the illness. We believe that a biological response modifier glucan (BRMG), which has been shown in clinical studies of DMD to boost the expression of vascular smooth muscle dystrophin and provide anti-fibrotic and anti-inflammatory effects, may play a key role in reducing the pathogenesis of DMD. According to the evaluation of biomarkers, this BRMG, which is safe and side-effect-free, reduces the pathogenesis of DMD. We describe the possible mechanisms of action by which this BRMG helps in alleviating the symptoms of DMD by targeting smooth muscle dystrophin, in addition to its advantages over other therapeutic modalities, as well as how it can serve as a valuable adjunct to existing therapies. We suggest that using BRMG adjuncts that target smooth muscle dystrophin would be a potential therapeutic approach that prolongs the lifespan and extends the duration of ambulation from the onset of DMD. Further studies are needed to validate this hypothesis.
MeSH term(s)	Humans ; Dystrophin/genetics ; Muscle, Smooth, Vascular ; Muscular Dystrophy, Duchenne/drug therapy ; Muscle, Skeletal ; Drug-Related Side Effects and Adverse Reactions ; Glucans
Chemical Substances	Dystrophin ; Glucans
Language	English
Publishing date	2023-09-09
Publishing country	Japan
Document type	Journal Article
ISSN	1884-8796
ISSN (online)	1884-8796
DOI	10.1540/jsmr.59.67
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Article ; Online: Potentials to alleviate coagulopathy and enhance microglial function of beta (β)- glucans, making them worth a clinical study for COVID-19's neurological sequalae.

Raghavan, Kadalraja / Kandaswamy, Ramesh Shankar / Ikewaki, Nobunao / Iwasaki, Masaru / Abraham, Samuel J K

Journal of the neurological sciences

2021 Volume 427, Page(s) 117554

MeSH term(s)	COVID-19 ; Humans ; Microglia ; SARS-CoV-2 ; beta-Glucans
Chemical Substances	beta-Glucans
Language	English
Publishing date	2021-06-22
Publishing country	Netherlands
Document type	Letter
ZDB-ID	80160-4
ISSN	1878-5883 ; 0022-510X ; 0374-8642
ISSN (online)	1878-5883
ISSN	0022-510X ; 0374-8642
DOI	10.1016/j.jns.2021.117554
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Article ; Online: Improvement of behavioural pattern and alpha-synuclein levels in autism spectrum disorder after consumption of a beta-glucan food supplement in a randomised, parallel-group pilot clinical study.

Raghavan, Kadalraja / Dedeepiya, Vidyasagar Devaprasad / Ikewaki, Nobunao / Sonoda, Tohru / Iwasaki, Masaru / Preethy, Senthilkumar / Abraham, Samuel Jk

BMJ neurology open

2022 Volume 4, Issue 1, Page(s) e000203

Abstract: Background: Autism spectrum disorders (ASDs) are a wide range of behavioural disabilities for which there are no definite interventional modalities available. Remedial therapies remain the only option but with varying outcomes. We have evaluated the ... ...

Abstract	Background: Autism spectrum disorders (ASDs) are a wide range of behavioural disabilities for which there are no definite interventional modalities available. Remedial therapies remain the only option but with varying outcomes. We have evaluated the Childhood Autism Rating Scale (CARS) and alpha-synuclein levels in this parallel-group, multiple-arm pilot clinical study after supplementation with a biological response modifier beta-glucan food supplement (Nichi Glucan). Methods: Six subjects with ASD (n=6) Gr. 1 underwent conventional treatment comprising remedial behavioural therapies and L-carnosine 500 mg per day, and 12 subjects (n=12) Gr. 2 underwent supplementation with the Nichi Glucan 0.5 g two times per day along with the conventional treatment. Results: There was a significant decrease in the CARS score in all of the children of the Nichi Glucan Gr.2 compared with the control (p=0.034517). Plasma levels of alpha-synuclein were significantly higher in Gr. 2 (Nichi Glucan) than in the control group Gr. 1 (p=0.091701). Conclusion: Improvement of the behavioural pattern CARS score and a correlating alpha-synuclein level, followed by a safe beta-glucan food supplement, warrants further research on other parameters, such as gut-microbiota evaluation, and relevant neuronal biomarkers which is likely to cast light on novel solutions.
Language	English
Publishing date	2022-01-18
Publishing country	England
Document type	Journal Article
ISSN	2632-6140
ISSN (online)	2632-6140
DOI	10.1136/bmjno-2021-000203
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Article ; Online: Corrigendum to "Beneficial immune-modulatory effects of the N-163 strain of Aureobasidium pullulans-produced 1,3-1,6 Beta glucans in Duchenne muscular dystrophy: Results of an open-label, prospective, exploratory case-control clinical study" [IBRO Neurosci. Rep. 15 (2023), pp. 90-99].

Raghavan, Kadalraja / Dedeepiya, Vidyasagar Devaprasad / Srinivasan, Subramaniam / Pushkala, Subramanian / Bharatidasan, Sudhakar S / Ikewaki, Nobunao / Iwasaki, Masaru / Senthilkumar, Rajappa / Preethy, Senthilkumar / Abraham, Samuel J K

IBRO neuroscience reports

2023 Volume 15, Page(s) 149–150

Language	English
Publishing date	2023-08-09
Publishing country	Netherlands
Document type	Journal Article
ISSN	2667-2421
ISSN (online)	2667-2421
DOI	10.1016/j.ibneur.2023.08.001
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Article ; Online: Beneficial immune-modulatory effects of the N-163 strain of

IBRO neuroscience reports

2023 Volume 15, Page(s) 90–99

Abstract: Background: This exploratory case-control study is to evaluate the effects of supplementation of : Methods: Twenty-seven male subjects aged 5-19 years with DMD were included, nine in the control arm and 18 in the treatment arm to receive N-163 beta ... ...

Abstract	Background: This exploratory case-control study is to evaluate the effects of supplementation of Methods: Twenty-seven male subjects aged 5-19 years with DMD were included, nine in the control arm and 18 in the treatment arm to receive N-163 beta glucan along with conventional therapies for 45 days. While performing the analysis, steroid usage was also taken into consideration, those not administered steroids (Steroid -ve) (Control, n = 5; treatment, n = 9), those administered steroids (Steroid +ve) (Control, n = 4; treatment, n = 9). Results: IL-6 showed a significant decrease in the treatment groups, especially the N-163 Steroid -ve group. IL-13 decreased in both treatment groups and TGF-β levels showed a significant decrease in the treatment groups, especially the N-163 Steroid -ve group, (p < 0.05). Dystrophin levels increased by up to 32% in the treatment groups compared to the control. Medical research council (MRC) grading showed slight improvement in muscle strength improvement in 12 out of 18 patients (67%) in the treatment group and four out of nine (44%) subjects in the control group. Conclusion: Supplementation with the N-163 beta glucan food supplement produced beneficial effects: a significant decrease in inflammation and fibrosis markers, increase in serum dystrophin and slight improvement in muscle strength in DMD subjects over 45 days, thus making this a potential adjunct treatment for DMD after validation. Trial registration: The study was registered in Clinical trials registry of India, CTRI/2021/05/033346. Registered on 5th May, 2021.
Language	English
Publishing date	2023-07-04
Publishing country	Netherlands
Document type	Journal Article
ISSN	2667-2421
ISSN (online)	2667-2421
DOI	10.1016/j.ibneur.2023.06.007
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Article ; Online: Beneficial Immune Regulation by Biological Response Modifier Glucans in COVID-19 and Their Envisaged Potentials in the Management of Sepsis.

Preethy, Senthilkumar / Raghavan, Kadalraja / Dedeepiya, Vidyasagar Devaprasad / Surya Prakash, Vaddi / Ikewaki, Nobunao / Ikeue, Yasunori / Nagataki, Mitsuru / Iwasaki, Masaru / Senthilkumar, Rajappa / Abraham, Samuel J K

Frontiers in immunology

2022 Volume 13, Page(s) 870632

Abstract: Sepsis is a life-threatening condition caused by an abnormal immune response induced by infection with no approved or specific therapeutic options. We present our perspectives for the therapeutic management of sepsis through a four-way approach: (1) ... ...

Abstract	Sepsis is a life-threatening condition caused by an abnormal immune response induced by infection with no approved or specific therapeutic options. We present our perspectives for the therapeutic management of sepsis through a four-way approach: (1) infection control through immune enhancement; (2) immune suppression during the initial hyper-inflammatory phase; (3) balanced immune-modulation to counter the later immune-paralysis phase; and (4) advantageous effects on metabolic and coagulation parameters throughout. COVID-19 is a virus-triggered, accelerated sepsis-like reaction that is associated with the rapid progress of an inflammatory cascade involving a cytokine storm and multiorgan failure. Here, we discuss the potential of the biological response modifiers, β-glucans (BRMGs), in the management of sepsis based on their beneficial effects on inflammatory-immune events in COVID-19 clinical studies. In COVID-19 patients, apart from metabolic regulation, BRMGs, derived from a black yeast,
MeSH term(s)	C-Reactive Protein ; COVID-19 ; Glucans/pharmacology ; Humans ; Immunologic Factors ; Interleukin-6 ; Sepsis ; beta-Glucans/therapeutic use
Chemical Substances	Glucans ; Immunologic Factors ; Interleukin-6 ; beta-Glucans ; C-Reactive Protein (9007-41-4)
Language	English
Publishing date	2022-06-27
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2022.870632
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