scholarly journals Recent Developments in Clinical Applications of Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis and Osteoarthritis

2021 ◽  
Vol 12 ◽  
Author(s):  
Joel Jihwan Hwang ◽  
Yeri Alice Rim ◽  
Yoojun Nam ◽  
Ji Hyeon Ju
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Clinical Applications ◽  
Clinical Settings ◽  
Positive Outcomes ◽  
Joint Function ◽  
Safety And Efficacy ◽  
High Expectations ◽  
Recent Developments

Mesenchymal stem cell (MSC) therapies have been used as cell-based treatments for decades, owing to their anti-inflammatory, immunomodulatory, and regenerative properties. With high expectations, many ongoing clinical trials are investigating the safety and efficacy of MSC therapies to treat arthritic diseases. Studies on osteoarthritis (OA) have shown positive clinical outcomes, with improved joint function, pain level, and quality of life. In addition, few clinical MSC trials conducted on rheumatoid arthritis (RA) patients have also displayed some optimistic outlook. The largely positive outcomes in clinical trials without severe side effects establish MSCs as promising tools for arthritis treatment. However, further research is required to investigate its applicability in clinical settings. This review discusses the most recent advances in clinical studies on MSC therapies for OA and RA.

scholarly journals Use of Herbal Medications for Treatment of Osteoarthritis and Rheumatoid Arthritis

Medicines ◽  
2020 ◽  
Vol 7 (11) ◽  
pp. 67
Author(s):  
Breanna N. Lindler ◽  
Katelyn E. Long ◽  
Nancy A. Taylor ◽  
Wei Lei
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
The United States ◽  
Pharmacological Therapy ◽  
Effective Management ◽  
Pharmacological Interventions ◽  
Safety And Efficacy ◽  
Herbal Medications ◽  
Anti Oxidant

Arthritis is a chronic condition that affects nearly a quarter of the United States population. Osteoarthritis (OA) and rheumatoid arthritis (RA) are two major forms of arthritis associated with severe joint pain and reduced quality of life. Various pharmacological interventions may be utilized for arthritis treatment when non-pharmacological therapy is insufficient. However, pharmacological therapy can be associated with serious side effects and high costs. Therefore, alternative therapies have been under investigation. Herbal medications have shown the potential for safe and effective management of arthritis. For this review, we attempt to summarize the mechanisms, safety, and efficacy of herbal treatments for OA and RA. After searching electronic databases, we identified nine herbs among 23 clinical trials used for the treatment of OA or RA patients. Improvement of OA and RA symptoms, pain, and inflammation was demonstrated. The herbs exhibited strong anti-inflammatory and anti-oxidant activities, contributing to a reduction in inflammation and tissue damage. Several herbs elucidated new mechanisms for OA and RA treatment as well. Though these herbs have shown promise for OA and RA treatment, more studies and clinical trials are required for determining safety and efficacy, bioactivity, and optimal bioavailability.

scholarly journals The exosome journey: from biogenesis to uptake and intracellular signalling

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Sonam Gurung ◽  
Dany Perocheau ◽  
Loukia Touramanidou ◽  
Julien Baruteau
Keyword(s):  
Clinical Trials ◽  
Plasma Membrane ◽  
Scientific Community ◽  
Cell Types ◽  
Clinical Applications ◽  
Clinical Development ◽  
Intracellular Signalling ◽  
Clinical Settings ◽  
Health And Disease ◽  
Adequate Definition

AbstractThe use of exosomes in clinical settings is progressively becoming a reality, as clinical trials testing exosomes for diagnostic and therapeutic applications are generating remarkable interest from the scientific community and investors. Exosomes are small extracellular vesicles secreted by all cell types playing intercellular communication roles in health and disease by transferring cellular cargoes such as functional proteins, metabolites and nucleic acids to recipient cells. An in-depth understanding of exosome biology is therefore essential to ensure clinical development of exosome based investigational therapeutic products. Here we summarise the most up-to-date knowkedge about the complex biological journey of exosomes from biogenesis and secretion, transport and uptake to their intracellular signalling. We delineate the major pathways and molecular players that influence each step of exosome physiology, highlighting the routes of interest, which will be of benefit to exosome manipulation and engineering. We highlight the main controversies in the field of exosome research: their adequate definition, characterisation and biogenesis at plasma membrane. We also delineate the most common identified pitfalls affecting exosome research and development. Unravelling exosome physiology is key to their ultimate progression towards clinical applications.

scholarly journals Can prospective systematic reviews of animal studies improve clinical translation?

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Pandora Pound ◽  
Merel Ritskes-Hoitinga
Keyword(s):  
Clinical Trials ◽  
Systematic Reviews ◽  
Animal Studies ◽  
Poor Quality ◽  
Human Studies ◽  
Clinical Knowledge ◽  
Safety And Efficacy ◽  
High Quality Evidence ◽  
Animal Data

AbstractSystematic reviews are powerful tools with the potential to generate high quality evidence. Their application to animal studies has been instrumental in exposing the poor quality of these studies, as well as a catalyst for improvements in study design, conduct and reporting. It has been suggested that prospective systematic reviews of animal studies (i.e. systematic reviews conducted prior to clinical trials) would allow scrutiny of the preclinical evidence, providing valuable information on safety and efficacy, and helping to determine whether clinical trials should proceed. However, while prospective systematic reviews allow valuable scrutiny of the preclinical animal data, they are not necessarily able to reliably predict the safety and efficacy of an intervention when trialled in humans. Consequently, they may not reliably safeguard humans participating in clinical trials and might potentially result in lost opportunities for beneficial clinical treatments. Furthermore, animal and human studies are often conducted concurrently, which not only makes prospective systematic reviews of animal studies impossible, but suggests that animal studies do not inform human studies in the manner presumed. We suggest that this points to a confused attitude regarding animal studies, whereby tradition demands that they precede human studies but practice indicates that their findings are often ignored. We argue that it is time to assess the relative contributions of animal and human research in order to better understand how clinical knowledge is actually produced.

scholarly journals Nanopharmaceutics: Part I—Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU

Pharmaceutics ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 146 ◽  
Author(s):  
Eliana B. Souto ◽  
Gabriela F. Silva ◽  
João Dias-Ferreira ◽  
Aleksandra Zielinska ◽  
Fátima Ventura ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Scale Up ◽  
Intravenous Iron ◽  
Matrix Composition ◽  
Clinical Settings ◽  
The European Union ◽  
Production Methods ◽  
Good Manufacturing Practices ◽  
Copolymer Micelle

The latest advances in pharmaceutical technology are leading to the development of cutting edged approaches to produce what is now known as the “Holy Grail” of medicine—nanopharmaceutics. Over the latest decade, the pharmaceutical industry has made important contributions to the scale up of these new products. To ensure their quality, efficacy, and safety for human use, clinical trials are mandatory. Yet, regulation regarding nanopharmaceuticals is still limited with a set of guidelines being recently released with respect to compliance with quality and safety. For the coming years, updates on regulatory issues about nanopharmaceuticals and their use in clinical settings are expected. The use of nanopharmaceuticals in clinical trials depends on the approval of the production methods and assurance of the quality of the final product by implementation and verification of the good manufacturing practices (GMP). This review addresses the available legislation on nanopharmaceuticals within the European Union (EU), the GMP that should be followed for their production, and the current challenges encountered in clinical trials of these new formulations. The singular properties of nanopharmaceuticals over their bulk counterparts are associated with their size, matrix composition, and surface properties. To understand their relevance, four main clinical trial guidelines, namely, for intravenous iron-based nanopharmaceuticals, liposomal-based nanopharmaceuticals, block copolymer micelle-based nanopharmaceuticals, and related to surface coating requirements, are described here.

Measuring clinical practice: science and methods

2013 ◽  
Vol 34 (1) ◽  
pp. E3 ◽  
Author(s):  
Peter D. Angevine ◽  
Paul C. McCormick
Keyword(s):  
Clinical Trials ◽  
Clinical Data ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Treatment Options ◽  
Routine Practice ◽  
Clinical Settings ◽  
Clinical Registries ◽  
Basic Understanding

The routine practice of neurosurgery generates a large amount of clinical data. The structured, systematic capture of this information using clinical registries or other rigorously designed observational studies can yield useful evidence to help improve the care of patients. Registries in particular can be designed to measure outcomes in real-world clinical settings and to study differences in outcomes between subgroups. This information can help clinicians to advise patients regarding their treatment options. To provide valid, generalizable evidence, however, registries and other observational studies must be designed and conducted with a rigor similar to that of randomized clinical trials. Neurosurgeons with a basic understanding of the potential advantages and pitfalls of nonrandomized trials and the methods of statistical analysis will be able to assess the quality of clinical data and to incorporate the findings appropriately into their patients' care.

scholarly journals Manufacturing and Banking Canine Adipose-Derived Mesenchymal Stem Cells for Veterinary Clinical Application

2021 ◽  
Author(s):  
Huina Luo ◽  
Dongsheng Li ◽  
Zhisheng Chen ◽  
Bingyun Wang ◽  
Shengfeng Chen
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Normal Karyotype ◽  
Clinical Applications ◽  
Therapeutic Application ◽  
Differentiation Potential ◽  
Safety And Efficacy

Abstract BACKGROUND: Mesenchymal stem cells (MSCs) have generated a great amount of interest in recent years as a novel therapeutic application for improving the quality of pet life and helping them free from painful conditions and diseases. It has now become critical to address the challenges related to the safety and efficacy of MSCs expanded in vitro. In this study, we establish a standardized process for manufacture of canine adipose-derived MSCs (AD-MSCs), including tissue sourcing, cell isolation and culture, cryopreservation, thawing and expansion, quality control and testing, and evaluate the safety and efficacy of those cells for clinical applications. RESULTS: After expansion, the viability of AD-MSCs manufactured under our standardized process was above 90 %. Expression of surface markers and differentiation potential was consistent with ISCT standards. Sterility, mycoplasma, and endotoxin tests were consistently negative. AD-MSCs presented normal karyotype, and did not form in vivo tumors. No adverse events were noted in two cases treated with intravenously AD-MSCs. CONCLUSION: Herein we demonstrated the establishment of a feasible bioprocess for manufacturing and banking canine AD-MSCs for veterinary clinical use.

Benefit-Finding and Growth

2009 ◽  
pp. 632-640 ◽  
Author(s):  
Suzanne C. Lechner ◽  
Howard Tennen ◽  
Glenn Affleck
Keyword(s):  
Life Events ◽  
Clinical Applications ◽  
Benefit Finding ◽  
Positive Thinking ◽  
Positive Outcomes ◽  
Adverse Life Events ◽  
Future Directions ◽  
Self Reliance ◽  
New Treatments

Following adverse life events, many people report positive outcomes, sometimes referred to as benefit finding and growth (or BFG). Some people experience a new appreciation of their own strength and resilience or an increased self-reliance. Others describe strengthened relationships and increased closeness with others, greater compassion or altruism, a heightened sense of the fragility of life, or changes in life philosophies and spirituality. This chapter addresses several unresolved issues in the study of BFG, including whether an individual's ability to find benefits in a stressful or traumatic life event is an important contributor to subsequent quality of life and adjustment; how BFG perceptions develop and are maintained over time; shortcomings of current indicators purporting to measure benefits in the context of adversity; future directions for research in this area; and clinical applications of research in BFG. In this chapter, we take a new look at the BFG literature, revisit concerns identified in the first edition of this Handbook, and raise new concerns regarding how BFG is currently assessed and translated into new treatments. We caution against the rush to create interventions to enhance BFG in light of the potential detrimental effects on victimized individuals created by our societal emphasis on the power of positive thinking.

scholarly journals Dietary Interventions with Polyphenols in Osteoarthritis: A Systematic Review Directed from the Preclinical Data to Randomized Clinical Studies

Nutrients ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1420
Author(s):  
Evdokia Valsamidou ◽  
Aristea Gioxari ◽  
Charalampia Amerikanou ◽  
Panagiotis Zoumpoulakis ◽  
George Skarpas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Synergistic Effects ◽  
Antioxidant Properties ◽  
Research Field ◽  
Clinical Settings ◽  
Dietary Interventions ◽  
Interesting Approach ◽  
Relationship Of

Osteoarthritis (OA) is the most common form of arthritis and a major cause of limited functionality and thus a decrease in the quality of life of the inflicted. Given the fact that the existing pharmacological treatments lack disease-modifying properties and their use entails significant side effects, nutraceuticals with bioactive compounds constitute an interesting field of research. Polyphenols are plant-derived molecules with established anti-inflammatory and antioxidant properties that have been extensively evaluated in clinical settings and preclinical models in OA. As more knowledge is gained in the research field, an interesting approach in the management of OA is the additive and/or synergistic effects that polyphenols may have in an optimized supplement. Therefore, the aim of this review was to summarize the recent literature regarding the use of combined polyphenols in the management of OA. For that purpose, a PubMed literature survey was conducted with a focus on some preclinical osteoarthritis models and randomized clinical trials on patients with osteoarthritis from 2018 to 2021 which have evaluated the effect of combinations of polyphenol-rich extracts and purified polyphenol constituents. Data indicate that combined polyphenols may be promising for the treatment of osteoarthritis in the future, but more clinical trials with novel approaches in the identification of the in-between relationship of such constituents are needed.

scholarly journals Favipiravir for treating patients with novel coronavirus (COVID-19): protocol for a systematic review and meta-analysis of randomised clinical trials

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e039730 ◽  
Author(s):  
Morteza Arab-Zozani ◽  
Soheil Hassanipour ◽  
Djavad Ghoddoosi-Nejad
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Code Of Ethics ◽  
Meta Analysis ◽  
Randomised Clinical Trials ◽  
Secondary Outcome ◽  
Eligibility Criteria ◽  
Safety And Efficacy ◽  
Statistical Heterogeneity

IntroductionAn outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was reported in Wuhan, China, in mid-December 2019, and declared a pandemic by the WHO on 11 March 2020. Due to the unknown nature of the disease and the lack of specific drugs, several potential treatments were used for patients. This systematic review and meta-analysis will evaluate studies of the effects of favipiravir in COVID-19 pneumonia.Methods and analysisWe will search electronic databases including LitCovid hub, PubMed, Scopus, ISI Web of Sciences, Cochrane and Embase using keywords related to COVID-19 and favipiravir. We will search the reference lists of all included studies and reviews. We will also search for clinical trial registries, such as ClinicalTrials.gov, for the ongoing clinical trials. All randomised clinical trials investigating the safety and efficacy of favipiravir compared with other control groups for the treatment of patients with confirmed infection with SARS-CoV-2 will be included. Patients’ survival at the end of the treatment as well as the follow-up will be the primary outcome of the treatment, followed by the time and rate of the patient with a negative COVID-19 test. The desired secondary outcome will consist of a decreased rate of symptoms, proportion of intensive care unit (ICU) transfers, length of the hospital stay, ICU treatments, the quality of life and additional adverse events. Data synthesis will be conducted using CMA V.2. Two independent investigators will be screening titles, abstracts and full texts of included studies, based on eligibility criteria. These investigators will then independently extract the data and appraise the quality of said studies. All potential discrepancies will be resolved through consultation with the third reviewer. Statistical heterogeneity will be assessed using a standard I2 test. A funnel plot, Egger’s test and Begg’s test will be used for detecting asymmetry to explore possible publication bias.Ethics and disseminationAll findings of this systematic review and meta-analysis will help identify the safety and efficacy of favipiravir for patients with COVID-19. Given that the design of the study is a systematic review, there is no need to follow the code of ethics protocol. The results of this study will be published in a reputable journal.PROSPERO registration numberCRD42020180032.

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