The evolving regulatory landscape in regenerative medicine.

Regenerative medicine as a field has emerged as a new component of modern medicine and medical research that encompasses a wide range of products including cellular and acellular therapies. As this new field emerged, regulatory agencies like the Food and Drug Administration (FDA) rapidly adapted existing regulatory frameworks to address the transplantation, gene therapy, cell-based therapeutics, and acellular biologics that fall under the broader regenerative medicine umbrella. Where it has not been possible to modify existing regulation and processes, entirely new frameworks have been generated with the intention of providing flexible, forward-facing systems to regulate this rapidly growing field. This review discusses the current state of FDA regulatory affairs in the context of stem cells and extracellular vesicles by highlighting gaps in the current regulatory system and then discussing where regulatory science in regenerative medicine may be headed based on these gaps and the FDA's historical ability to deal with emerging fields. Lastly, we utilize case studies in stem cell and acellular based treatments to demonstrate how regulatory science has evolved in regenerative medicine and highlight the ongoing clinical efforts and challenges of these therapies.

COVID-19, Myocarditis and Pericarditis.

Viral infections are a leading cause of myocarditis and pericarditis worldwide, conditions that frequently coexist. Myocarditis and pericarditis were some of the early comorbidities associated with SARS-CoV-2 infection and COVID-19. Many epidemiologic studies have been conducted since that time concluding that SARS-CoV-2 increased the incidence of myocarditis/pericarditis at least 15× over pre-COVID levels although the condition remains rare. The incidence of myocarditis pre-COVID was reported at 1 to 10 cases/100 000 individuals and with COVID ranging from 150 to 4000 cases/100 000 individuals. Before COVID-19, some vaccines were reported to cause myocarditis and pericarditis in rare cases, but the use of novel mRNA platforms led to a higher number of reported cases than with previous platforms providing new insight into potential pathogenic mechanisms. The incidence of COVID-19 vaccine-associated myocarditis/pericarditis covers a large range depending on the vaccine platform, age, and sex examined. Importantly, the findings highlight that myocarditis occurs predominantly in male patients aged 12 to 40 years regardless of whether the cause was due to a virus-like SARS-CoV-2 or associated with a vaccine-a demographic that has been reported before COVID-19. This review discusses findings from COVID-19 and COVID-19 vaccine-associated myocarditis and pericarditis considering the known symptoms, diagnosis, management, treatment, and pathogenesis of disease that has been gleaned from clinical research and animal models. Sex differences in the immune response to COVID-19 are discussed, and theories for how mRNA vaccines could lead to myocarditis/pericarditis are proposed. Additionally, gaps in our understanding that need further research are raised.

Urban and Peri-Urban Agriculture as a Nature-Based Solution to Support Food Supply, Health and Well-Being in Bucharest Metropolitan Area During the COVID-19 Pandemic

Cities and metropolitan areas are becoming increasingly vulnerable to various environmental and socio-economic disturbances, posing a growing concern to food security, public health and well-being. This chapter intends to address two concepts that have only recently been addressed together – urban and peri-urban agriculture (UPUA) and nature-based solutions (NbS) – through their potential to mitigate the effects of the COVID-19 pandemic associated challenges in Bucharest Metropolitan Area. The work relies on statistical and spatial data related to UPUA as NbS initiatives, being identified two main types: bottom-up (e.g. community, private companies, or NGOs) and top-down (from the local authorities). Lessons learnt from experimenting with NBS during the pandemic period can be relevant for urban governance to further innovate and replicate the successful initiatives. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Sex-Specific Effects of Plastic Caging in Murine Viral Myocarditis.

BACKGROUND: Myocarditis is an inflammatory heart disease caused by viral infections that can lead to heart failure, and occurs more often in men than women. Since animal studies have shown that myocarditis is influenced by sex hormones, we hypothesized that endocrine disruptors, which interfere with natural hormones, may play a role in the progression of the disease. The human population is exposed to the endocrine disruptor bisphenol A (BPA) from plastics, such as water bottles and plastic food containers. METHODS: Male and female adult BALB/c mice were housed in plastic versus glass caging, or exposed to BPA in drinking water versus control water. Myocarditis was induced with coxsackievirus B3 on day 0, and the endpoints were assessed on day 10 post infection. RESULTS: We found that male BALB/c mice that were exposed to plastic caging had increased myocarditis due to complement activation and elevated numbers of macrophages and neutrophils, whereas females had elevated mast cell activation and fibrosis. CONCLUSIONS: These findings show that housing mice in traditional plastic caging increases viral myocarditis in males and females, but using sex-specific immune mechanisms.

Territorial characteristics of the vaccination process in Romania. evidence at a local level

In the context of the SARS-CoV-2 pandemic crisis, declared by the World Health Organization in March, 2020, a sustainable and permanent solution was the development of an efficacious and safe vaccine against the virus. This study aims to be a picture of the vaccination process (VP), performed at the end of February, 2021, on the subject of the population at risk - e.g the elderly (one category of persons targeted by the second stage of VP). The present paper aims to analyze several geographic features of the VP in Romania, such as: (i) the territorial distribution of vaccination centers (VCs);(ii) their capacity to cover the potential needs of the local population in terms of the anti-COVID-19 vaccination;(iii) the spatial itineraries induced to the elderly population by the overly-busy VCs;(iv) the effect of a VC on local economy, especially in rural settlements and small towns. The used research methods are of a qualitative and quantitative nature (e.g. official statistical public documents analyses, interviews) and the analysis is performed at the lowest territorial level at which statistical data are available, namely the Local Administrative Units (LAU). The main conclusion is that the topic of the VC's geographic position should be studied on a local scale, for that the VP to have a positive impact on population, wherever it may be.

Brief Review on COVID-19: The 2020 Pandemic Caused by SARS-CoV-2.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus responsible for the coronavirus disease of 2019 (COVID-19). First identified in Wuhan (Hubei, China) in December of 2019, it has since been declared a pandemic by the World Health Organization in March of 2020. In this study, we will provide a brief review of viral origin, identification, symptoms, transmission, diagnosis, and potential treatment strategies for the newly identified SARS-CoV-2 strain.