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Cardiovascular diseases are the leading cause of morbidity and mortality in the United States. Cardiac tissue engineering is a direction in regenerative medicine that aims to repair various heart defects with the long-term goal of artificially rebuilding a full-scale organ that matches its native structure and function. Three-dimensional (3D) bioprinting offers promising applications through its layer-by-layer biomaterial deposition using different techniques and bio-inks. In this review, we will introduce cardiac tissue engineering, 3D bioprinting processes, bioprinting techniques, bio-ink materials, areas of limitation, and the latest applications of this technology, alongside its future directions for further innovation. [ABSTRACT FROM AUTHOR]

This article discusses ownership and property issues in three-dimensional (3D) bioprinting from the perspective of the tangible aspect of the technology. Many scholars have examined property issues in the intangible aspect of the technology, namely, the intellectual property issue. Since a major component of 3D bioprinting is cells taken from patients and donors, it is important to explore the right of ownership over the physical product, including cells used in the 3D bioprinting process and the 3D bioprinted organ itself. What is the extent of the donor's right over his/her cells taken for use in 3D bioprinting and even the 3D bioprinted organ - the product of those cells? For example, can the cell donor determine how his/her cells are used, or even who gets the 3D bioprinted organ? What rights does a person have over the commercial use of his/her cells or tissue for 3D bioprinting? [ABSTRACT FROM AUTHOR]

The limitations of traditional cancer treatments are driving the creation and development of new nanomedicines. At present, with the rapid increase of research on nanomedicine in the field of cancer, there is a lack of intuitive analysis of the development trend, main authors and research hotspots of nanomedicine in the field of cancer, as well as detailed elaboration of possible research hotspots. In this review, data collected from the Web of Science Core Collection database between January 1st, 2000, and December 31st, 2021, were subjected to a bibliometric analysis. The co-authorship, co-citation, and co-occurrence of countries, institutions, authors, literature, and keywords in this subject were examined using VOSviewer, Citespace, and a well-known online bibliometrics platform. We collected 19,654 published papers, China produced the most publications (36.654%, 7204), followed by the United States (29.594%, 5777), and India (7.780%, 1529). An interesting fact is that, despite China having more publications than the United States, the United States still dominates this field, having the highest H-index and the most citations. Acs Nano, Nano Letters, and Biomaterials are the top three academic publications that publish articles on nanomedicine for cancer out of a total of 7580 academic journals. The most significant increases were shown for the keywords "cancer nanomedicine", "tumor microenvironment", "nanoparticles", "prodrug", "targeted nanomedicine", "combination", and "cancer immunotherapy" indicating the promising area of research. Meanwhile, the development prospects and challenges of nanomedicine in cancer are also discussed and provided some solutions to the major obstacles. [Display omitted] • Data of current nanomedicine in cancer were collected from the Web of Science. • Collected data were systematically analyzed through bibliometric analysis. • Many keywords of nanomedicine in cancer were intuitively analyzed. • Hotspots, emerging frontiers and trend of nanomedicine in cancer were investigated. • Development prospects and challenges of nanomedicine in cancer were discussed. [ABSTRACT FROM AUTHOR]

Vaccines have been used to prevent and eradicate different diseases for over 200 years, and new vaccine technologies have the potential to prevent many common illnesses. Cancer, despite many advances in therapeutics, is still the second leading causes of death in the United States. Prophylactic, or preventative, cancer vaccines have the potential to reduce cancer prevalence by initiating a specific immune response that will target cancer before it can develop. Cancer vaccines can include many different components, such as peptides and carbohydrates, and be fabricated for delivery using a variety of means including through incorporation of stabilizing chemicals like polyethylene glycol (PEG) and pan-DR helper T-lymphocyte epitope (PADRE), fusion with antigen-presenting cells (APCs), microneedle patches, and liposomal encapsulation. There are currently five cancer vaccines used in the clinic, protecting against either human papillomavirus (HPV) or hepatitis B virus (HBV), and preventing several different types of cancer including cervical and oral cancer. Prophylactic cancer vaccines can promote three different types of adaptive responses: humoral (B cell, or antibody-mediated), cellular (T cell) or a combination of the two types. Each vaccine has its advantages and challenges at eliciting an adaptive immune response, but these prophylactic cancer vaccines in development have the potential to prevent or delay tumor development, and reduce the incidence of many common cancers. [ABSTRACT FROM AUTHOR]

Gastrointestinal disease burden continues to rise in the United States and worldwide. The development of bioengineering strategies to model gut injury or disease and to reestablish functional gut tissue could expand therapeutic options and improve clinical outcomes. Current approaches leverage a rapidly evolving gut bioengineering toolkit aimed at 1) de novo generation of gutlike tissues at multiple scales for microtissue models or implantable grafts and 2) regeneration of functional gut in vivo. Although significant progress has been made in intestinal organoid cultures and engineered tissues, development of predictive in vitro models and effective regenerative therapies remains challenging. In this review, we survey emerging bioengineering tools and recent methodological advances to identify current challenges and future opportunities in gut bioengineering for disease modeling and regenerative medicine. [ABSTRACT FROM AUTHOR]

The field of craniomaxillofacial (CMF) surgery is rich in pathological diversity and broad in the ages that it treats. Moreover, the CMF skeleton is a complex confluence of sensory organs and hard and soft tissue with load-bearing demands that can change within millimeters. Computer-aided design (CAD) and additive manufacturing (AM) create extraordinary opportunities to repair the infinite array of craniomaxillofacial defects that exist because of the aforementioned circumstances. 3D printed scaffolds have the potential to serve as a comparable if not superior alternative to the " gold standard " autologous graft. In vitro and in vivo studies continue to investigate the optimal 3D printed scaffold design and composition to foster bone regeneration that is suited to the unique biological and mechanical environment of each CMF defect. Furthermore, 3D printed fixation devices serve as a patient-specific alternative to those that are available off-the-shelf with an opportunity to reduce operative time and optimize fit. Similar benefits have been found to apply to 3D printed anatomical models and surgical guides for preoperative or intraoperative use. Creation and implementation of these devices requires extensive preclinical and clinical research, novel manufacturing capabilities, and strict regulatory oversight. Researchers, manufacturers, CMF surgeons, and the United States Food and Drug Administration (FDA) are working in tandem to further the development of such technology within their respective domains, all with a mutual goal to deliver safe, effective, cost-efficient, and patient-specific CMF care. This manuscript reviews FDA regulatory status, 3D printing techniques, biomaterials, and sterilization procedures suitable for 3D printed devices of the craniomaxillofacial skeleton. It also seeks to discuss recent clinical applications, economic feasibility, and future directions of this novel technology. By reviewing the current state of 3D printing in CMF surgery, we hope to gain a better understanding of its impact and in turn identify opportunities to further the development of patient-specific surgical care.

Summary: The purpose of this risk assessment (RA) was to qualitatively estimate the risk of emergence of the Japanese encephalitis virus (JEV) in the United States (US). We followed the framework for RA of emerging vector‐borne livestock diseases (de Vos et al. 2011), which consists of a structured questionnaire, whose answers to questions can be delivered in risk categories, descriptive statements, or yes or no type of answers, being supported by the literature. The most likely pathways of introduction of JEV identified were: (a) entry through infected vectors (by aircraft, cargo ships, tires, or wind); (b) import of infected viremic animals; (c) entry of viremic migratory birds; (d) import of infected biological materials; (e) import of infected animal products; (f) entry of infected humans; and (g) import/production of contaminated biological material (e.g., vaccines). From these pathways, the probability of introduction of JEV through infected adult mosquitoes via aircraft was considered very high and via ships/containers was deemed low to moderate. The probability of introduction via other pathways or modes of entry (vector eggs or larvae, hosts, and vaccines) was considered negligible. The probability of transmission of JEV was variable, ranging from low to high (in the presence of both competent vectors and hosts), depending on the area of introduction within the US. Lastly, the probability of establishment of JEV in the continental US was considered negligible. For that reason, we stopped the risk assessment at this point of the framework. This RA provides important information regarding the elements that contribute to the risk associated with the introduction of JEV in the US. This RA also indicates that infected mosquitoes transported in aircraft (and cargo ships) are the most likely pathway of JEV entry and therefore, mitigation strategies should be directed towards this pathway. [ABSTRACT FROM AUTHOR]

Type 1 diabetes mellitus (T1DM) is an autoimmune disease affecting 3 million individuals in the U.S. The pathogenesis of T1DM is driven by immune-mediated destruction of pancreatic β cells, the source of glucose regulator insulin. While T1DM can be successfully managed with insulin replacement therapy, approaches that can modify the underlying immuno-pathology of β cell destruction has been long sought after. Immunotherapy can attenuate T cell responses against β cell antigens. Given the detailed cellular and molecular definitions of T1DM immune responses, rational immunomodulation can be and have been developed in mouse models, and in some instances, tested in humans. The possibility of identifying individuals who are predisposed to T1DM through genotyping lend to the possibility of preventive vaccines. While much has been accomplished in delineating the mechanisms of immunotherapies, some of which are being tested in humans, long-term preservation of β cells and insulin independency has not been achieved. In this regard, the drug delivery field has much to offer in maximizing the benefits of immune modulators by optimizing spatiotemporal presentation of antigens and costimulatory signals. In this review, we attempt to capture the current state of T1DM immunotherapy by highlighting representative studies. Unlabelled Image [ABSTRACT FROM AUTHOR]

Biomaterials research output has experienced an exponential increase over the last three decades. The majority of research is published in the form of scientific articles and is therefore available as unstructured text, making it a challenging input for computational processing. Computational tools are becoming essential to overcome this information overload. Among them, text mining systems present an attractive option for the automated extraction of information from text documents into structured datasets. This work presents the first automated system for biomaterial related information extraction from the National Library of Medicine's premier bibliographic database (MEDLINE) research abstracts into a searchable database. The system is a text mining pipeline that periodically retrieves abstracts from PubMed and identifies research and clinical studies of biomaterials. Thereafter, the pipeline identifies sixteen concept types of interest in the abstract using the Biomaterials Annotator, a tool for biomaterials Named Entity Recognition (NER). These concepts of interest, along with the abstract and relevant metadata are then deposited in DEBBIE, the Database of Experimental Biomaterials and their Biological Effect. DEBBIE is accessible through a web application that provides keyword searches and displays results in an intuitive and meaningful manner, aiming to facilitate an efficient mapping and organization of biomaterials information., (© 2023 Wiley-VCH GmbH.)

Mammalian central nervous system (CNS) has limited capacity for regeneration. CNS injuries cause life-long debilitation and lead to $50 billion in healthcare costs in U.S. alone each year. Despite numerous efforts in the last few decades, CNS-related injuries remain as detrimental as they were 50 years ago. Some functional recovery can occur, but most regeneration are limited by an extracellular matrix (ECM) that actively inhibits axonal repair and promotes glial scarring. In most tissues, the ECM is an architectural foundation that plays an active role in supporting cellular development and regenerative response after injury. In mammalian CNS, however, this is not the case - its composition is not conducive for regeneration, with various molecules restricting plasticity and neuronal growth. In fact, the CNS ECM alters its composition dramatically following injury to restrict regeneration and to prioritize containment of injury as well as preservation of intact neural circuitry. This leads us to hypothesize that the inhibitory extracellular environment needs be modified or supplemented to be more regeneration-permissive for significant CNS regeneration. Mammalian nervous tissue cannot provide such ECM, and synthesizing it in a laboratory is beyond current technology. Evolutionarily lower species possess remarkably regenerative neural tissue. For example, small fresh-water dwelling zebrafish ( Danio rerio ) can regenerate severed spinal cord, re-gaining full motor function in a week. We believe their ECM contributes to its regenerative capability and that it can be harnessed to induce more regeneration in mammalian CNS. This study shows that ECM derived from zebrafish brains promotes more neuronal survival and axonal network formation than the widely studied and available ECM derived from mammalian tissues such as porcine brains, porcine urinary bladder, and rat brains. We believe its regenerative potential, combined with its affordability, easy handling, and fast reproduction, will make zebrafish an excellent candidate as a novel ECM source. [ABSTRACT FROM AUTHOR]

Muscle myopathies or defects, such as white striping (WS), downgrade the quality of broiler meat, leading to the loss of millions of dollars annually for the United States poultry industry. Visual inspection is currently practiced for assessing myopathies in broiler meat, which is however prone to human evaluation error, labor-intensive, and costly. Imaging technology that employs uniform or diffuse illumination has been investigated for assessing broiler meat quality, but their performance is not always satisfactory, especially for detecting subtle defects with few visual symptoms. This study presents the first proof-of-concept evaluation of the utility of an innovative technique for improved imaging of structures of biological materials, i.e., structured-illumination reflectance imaging (SIRI), for detecting WS conditions in broiler breast meat. Broiler breast fillets with varying degrees of WS severity were imaged by an in-house assembled SIRI system under sinusoidal illumination at different spatial frequencies (0.05–0.40 cycles/mm). The acquired pattern images were demodulated into direct components (DC) and amplitude components (AC) at each spatial frequency. Texture features were extracted from DC and AC images for building classification models using regularized linear discriminant analysis, which were to classify the poultry meat samples into 2, 3, and 4 classes, respectively, according to WS conditions. AC images were found by visual inspection more effective than DC in resolving WS characteristics, depending on the spatial frequency of illumination patterns. Compared to DC, AC yielded the maximum accuracy improvements of 8.33%, 7.93%, and 12.3% in 2-, 3- and 4-class classifications, respectively. Classification models using ranked features yielded similar improvements of up to 9.53% by AC over DC. The SIRI technique is promising for enhanced detection of WS and potentially other defects of broiler breast meat. • Structured-illumination reflectance imaging (SIRI) was used for poultry quality detection. • Amplitude component (AC) images enabled resolving white striping (WS) of broiler breast meat. • Broiler breast fillets were classified by models into 2, 3 and 4 classes according to WS conditions. • SIRI offered substantial improvements of up to 12% in classifying WS-affected poultry samples. [ABSTRACT FROM AUTHOR]

Burn injuries in the United States account for over one million hospital admissions per year, with treatment estimated at four billion dollars. Of severe burn patients, 30–90% will develop hypertrophic scars (HSc). In this study, we evaluate the impact of an elastomeric, randomly-oriented biostable polyurethane (PU) scaffold on HSc-related outcomes. In vitro , fibroblast-seeded PU scaffolds contracted significantly less and demonstrated fewer αSMA + myofibroblasts compared to fibroblast-seeded collagen lattices. In a murine HSc model, collagen coated PU (ccPU) scaffolds significantly reduced HSc contraction as compared to untreated control wounds and wounds treated with the clinical standard of care. Our data suggest that electrospun ccPU scaffolds meet the requirements to reduce HSc contraction including reduction of in vitro HSc related outcomes, diminished scar stiffness, and reduced scar contraction. While clinical dogma suggests treating severe burn patients with rapidly biodegrading skin equivalents, our data suggest that a more long-term scaffold may possess merit in reducing HSc. Statement of Significance In severe burns treated with skin grafting, between 30% and 90% of patients develop hypertrophic scars (HSc). There are no therapies to prevent HSc, and treatments are marginally effective. This work is the first example we are aware of which studies the impact of a permanent electrospun elastomer on HSc contraction in a murine model that mimics the human condition. Collagen coated polyurethane scaffolds decrease αSMA+ myofibroblast formation in vitro , prevent stiffening of scar tissue, and mitigate HSc contraction. Unlike current standards of care, electrospun, polyurethane scaffolds do not lose architecture over time. We propose that the future bioengineering strategy of mitigating HSc contraction should consider a long-term elastomeric matrix which persists within the wound bed throughout the remodeling phase of repair. [ABSTRACT FROM AUTHOR]

Globally health care spending is increasing unsustainably. This is especially true of the treatment of musculoskeletal (MSK) disease where in the United States the MSK disease burden has doubled over the last 15 years. With an aging and increasingly obese population, the surge in MSK related spending is only set to worsen. Despite increased funding, research and attention to this pressing health need, little progress has been made toward novel therapies. Tissue engineering and regenerative medicine (TERM) strategies could provide the solutions required to mitigate this mounting burden. Biomaterial-based treatments in particular present a promising field of potentially cost-effective therapies. However, the translation of a scientific development to a successful treatment is fraught with difficulties. These barriers have so far limited translation of TERM science into clinical treatments. It is crucial for primary researchers to be aware of the barriers currently restricting the progression of science to treatments. Researchers need to act prospectively to ensure the clinical, financial, and regulatory hurdles which seem so far removed from laboratory science do not stall or prevent the subsequent translation of their idea into a treatment. The aim of this review is to explore the development and translation of new treatments. Increasing the understanding of these complexities and barriers among primary researchers could enhance the efficiency of biomaterial translation. J. Cell. Physiol. 230: 36-49, 2016. © 2015 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Elizabeth Dianne Rekow, BSME, MSME, MBA, DDS, MS, Certificate in Orthodontics, and PhD (1944-2022), was a dental science futurist pursuing brave new paths during her career. She was one of the pivotal scientists who initiated the CAD/CAM movement in the 1980s and went on to focus on digital dentistry for the rest of her career. Her professional contributions involved seven patents, 92 peer-reviewed publications, 10 book contributions, 31 proceeding contributions, and well over 100 national and international presentations. She was an avid supporter of women in science. Her greatest contribution was her expansive imagination. She served as 35th president of the American Association for Dental, Oral, and Craniofacial Research in 2006-2007 and 88th president of the International Association for Dental Research in 2011-2012. The present article reviews key elements of her career and includes testimonies from friends about her special relationships.

With greater than 500,000 orthopaedic procedures performed in the United States each year requiring a bone graft, the development of novel graft materials is necessary. We report that some porous polymer/ceramic composite scaffolds possess intrinsic osteoinductivity as shown through their capacity to induce in vivo host osteoid mineralization and in vitro stem cell osteogenesis making them attractive synthetic bone graft substitutes. It was discovered that certain low crystallinity ceramics partially dissociate into simple signaling molecules (i.e., calcium and phosphate ions) that induce stem cells to endogenously produce their own osteoinductive proteins. Review of the literature has uncovered a variety of simple signaling molecules (i.e., gases, ions, and redox reagents) capable of inducing other desirable stem cell differentiation through endogenous growth factor production. Inductive simple signaling molecules, which we have termed inducerons, represent a paradigm shift in the field of regenerative engineering where they can be utilized in place of recombinant protein growth factors. [ABSTRACT FROM AUTHOR]

Abstract: The current definition of biomaterials differs vastly from it of just a decade ago. According to advancing technologies, it encompasses unpredictable materials such as engineered human cells and tissue. These biomaterials also have to be approved to use in health care business by regulatory authority, which are defined as drug, medical device, or biologics in the regulation. This Leading Opinion Paper addresses the regulatory issues of engineered human cells and tissue products using allogeneic cells that should have a great possibility to develop therapeutics for life-threating diseases or orphan diseases. Six allogeneic human cells and tissue products derived from neonatal or infant fibroblasts and/or keratinocytes were approved as medical devices or biologics in the United States as well as a hematopoietic cell product. For five of the seven products, well-controlled comparative clinical trials were conducted as pre-approval evaluation followed by post-approval evaluation. Although these products avoid a sterilization process usually used for medical devices, no serious malfunction that would lead to class 1 recall was reported. This article would provide insight for development of the engineered human cells and tissue. [Copyright &y& Elsevier]

Abstract: The ability to engineer particles has the potential to shift the paradigm in the creation of new medicines and diagnostics. Complete control over particle characteristics, such as size, shape, mechanical property, and surface chemistry, can enable rapid translation and facilitate the US Food and Drug Administration (FDA) approval of particle technologies for the treatment of cancer, infectious diseases, diabetes, and a host of other major illnesses. The incorporation of natural and artificial external stimuli to trigger the release of drugs enables exquisite control over the release profiles of drugs in a given environment. In this article, we examine several readily scalable top–down methods for the fabrication of shape-specific particles that utilize stimuli-responsive biomaterials for controlled drug delivery. Special attention is given to Particle Replication In Nonwetting Templates (PRINT®) technology and the application of novel triggered-release synthetic and natural polymers. [Copyright &y& Elsevier]

For polymers in tissue engineering to reach their full potential, the three-dimensional integration of cells with scaffolds must become more complex. In vascular grafts this is particularly challenging as specific physical property requirements must be met. We apply a combination of polymer processing techniques-electrospinning and femtosecond laser ablation-to produce microchannels inside the walls of electrospun tubes providing for spatially-controlled cell seeding. To determine if such a scaffold can provide the desired physical properties, a greater understanding of the relationship between manufacturing and mechanics is needed. As the strength of these scaffolds is an important functional component, the relative properties of single, bi- and tri-layer combinations produced using different solvents were compared. The effect of fiber layer thickness was also investigated. The thickness of the hexafluorisopropanol-derived layer dominated the overall scaffold properties regardless of the nature of the other two layers. Although laser-machined microchannels had substantial effects on single layer and some of the bilayers, in the 'final' trilayer scaffold, little effect on mechanical properties was observed. The concept of 'vascular wall engineering' could successfully produce trilayer composite scaffolds that maintain the targeted mechanical properties while allowing intricate, three-dimensional cell seeding. © 2011 Wiley Periodicals, Inc. J Appl Polym Sci, 2012 [ABSTRACT FROM AUTHOR]

Abstract: Several nerve guidance conduits (NGCs) and nerve protectant wraps are approved by the US Food and Drug Administration (FDA) for clinical use in peripheral nerve repair. These devices cover a wide range of natural and synthetic materials, which may or may not be resorbable. This review consolidates the data pertaining to all FDA approved materials into a single reference, which emphasizes material composition alongside pre-clinical and clinical safety and efficacy (where possible). This article also summarizes the key advantages and limitations for each material as noted in the literature (with respect to the indication considered). In this context, this review provides a comprehensive reference for clinicians which may facilitate optimal material/device selection for peripheral nerve repair. For materials scientists, this review highlights predicate devices and evaluation methodologies, offering an insight into current deficiencies associated with state-of-the-art materials and may help direct new technology developments and evaluation methodologies thereof. [Copyright &y& Elsevier]

The article focuses on the factors to consider in ensuring the compliance of increasing importance of the cold chain management in biopharmaceutical development. It states that training site personnel in correct shipping and receiving process for the temperature-sensitive biomaterials cannot be overdrawn and it is essential for cold chain partners' proper qualification. It says that persons who package the shipping of biomaterials must be certain and sufficient to avoid compromising the refrigerated biological materials' sample integrity. It relates that International Air Transport Association (IATA) standards for documentation and labels of biomaterials vary via hazard class. It adds that domestic transportation of biomaterials within the U.S. is an evolving process and heavily regulated.

Awareness of the regulatory environment is fundamental to understanding the biological assessment of biomaterials and medical devices. Medical devices are a diverse and heterogenous group of medical products and technologies defined by the lack of chemical action or requirement for metabolism. Regional activity and the Global Harmonization Task Force are now working on harmonizing the categorization and testing of medical devices. The International Organization for Standardization (ISO) has published 19 standards for biological evaluation. ISO 10993 standards are generally accepted outright or as an alternative to most national regulatory directives or acts, although Japan and the United States require more stringency in some tests. Type of materials, intended use, and risk are the basis for drafting testing programs for biomaterials and medical devices. With growth of the medical device industry and advent of new biomaterials and technologies, the need for toxicologic pathologists in safety (biocompatibility) and efficacy (conditions of use) evaluation of moderate- to high-risk devices is expanding. Preclinical evaluation of biomaterials and medical devices increasingly requires a basic understanding of materials science and bioengineering to facilitate interpretation of complex interface reactions between biomaterials, cellular and secretory factors, and vascular and tissue responses that modulate success or failure of medical devices. [ABSTRACT FROM AUTHOR]

There are >200,000 anterior cruciate ligament (ACL) ruptures each year in the United States, and, due to the poor healing properties of the ACL, surgical reconstruction with autograft or allograft tissue is the current treatment of these injuries. To regenerate the ACL, the ideal matrix should be biodegradable, porous, and exhibit sufficient mechanical strength to allow formation of neoligament tissue. Researchers have developed ACL scaffolds with collagen fibers, silk, biodegradable polymers, and composites with limited success. Our group has developed a biomimetic ligament replacement by using 3D braiding technology. In this preliminary in vivo rabbit model study for ACL reconstruction, the histological and mechanical evaluation demonstrated excellent healing and regeneration with our cell-seeded, tissue-engineered ligament replacement. [ABSTRACT FROM AUTHOR]

Polymer-based composites are a group of biomaterials that exert synergic and combined activity. There are multiple reported uses of these composites in multiple biomedical areas, such as drug carriers, in wound dressings, and, more prominently, in tissue engineering and regenerative medicine. Bone grafting is a promising field in the use of polymeric composites, as this is the second most frequently transplanted organ in the United States. Advances in novel biomaterials, such as polymeric composites, will undoubtedly be of great aid in bone tissue engineering and regeneration. In this paper, a general view of bone structure and polymeric composites will be given, discussing the potential role of these components in bone tissue. Moreover, the most relevant jawbone and maxillofacial applications of polymeric composites will be revised in this article, collecting the main knowledge about this topic and emphasizing the need of further clinical studies in humans. [ABSTRACT FROM AUTHOR]

Few university-based regenerative medicine innovations in the dental, oral, and craniofacial (DOC) space have been commercialized and affected clinical practice in the United States. An analysis of the commercial translation literature and National Institute for Dental and Craniofacial Research's (NIDCR's) portfolio identified barriers to commercial translation of university-based DOC innovations. To overcome these barriers, the NIDCR established the Dental Oral Craniofacial Tissue Regeneration Consortium. We provide generalized strategies to inform readers how to bridge the "valley of death" and more effectively translate DOC technologies from the research laboratory or early stage company environment to clinical trials and bring needed innovations to the clinic. Three valleys of death are covered: 1) from basic science to translational development, 2) from translational technology validation to new company formation (or licensing to an existing company), and 3) from new company formation to scaling toward commercialization. An adapted phase-gate model is presented to inform DOC regenerative medicine teams how to involve regulatory, manufacturability, intellectual property, competitive assessments, business models, and commercially oriented funding mechanisms earlier in the translational development process. An Industrial Partners Program describes how to conduct market assessments, industry maps, business development processes, and industry relationship management methods to sustain commercial translation through the later-stage valley of death. Paramount to successfully implementing these methods is the coordination and collaboration of interdisciplinary teams around specific commercial translation goals and objectives. We also provide several case studies for translational projects with an emphasis on how they addressed DOC biomaterials for tissue regeneration within a rigorous commercial translation development environment. These generalized strategies and methods support innovations within a university-based and early stage company-based translational development process, traversing the many funding gaps in dental, oral, and craniofacial regenerative medicine innovations. Although the focus is on shepherding technologies through the US Food and Drug Administration, the approaches are applicable worldwide.

Traumatic brain injuries (TBIs) are a significant health problem both in the United States and worldwide with over 27 million cases being reported globally every year. TBIs can vary significantly from a mild TBI with short-term symptoms to a moderate or severe TBI that can result in long-term or life-long detrimental effects. In the case of a moderate to severe TBI, the primary injury causes immediate damage to structural tissue and cellular components. This may be followed by secondary injuries that can be the cause of chronic and debilitating neurodegenerative effects. At present, there are no standard treatments that effectively target the primary or secondary TBI injuries themselves. Current treatment strategies often focus on addressing post-injury symptoms, including the trauma itself as well as the development of cognitive, behavioral, and psychiatric impairment. Additional therapies such as pharmacological, stem cell, and rehabilitative have in some cases shown little to no improvement on their own, but when applied in combination have given encouraging results. In this review, we will abridge and discuss some of the most recent research advances in stem cell therapies, advanced engineered biomaterials used to support stem transplantation, and the role of rehabilitative therapies in TBI treatment. These research examples are intended to form a multi-tiered perspective for stem-cell therapies used to treat TBIs; stem cells and stem cell products to mitigate neuroinflammation and provide neuroprotective effects, biomaterials to support the survival, migration, and integration of transplanted stem cells, and finally rehabilitative therapies to support stem cell integration and compensatory and restorative plasticity. [ABSTRACT FROM AUTHOR]

Cancer is the second leading cause of death in the United States, claiming more than 560,000 lives each year. Osteosarcoma (OS) is the most common primary malignant tumor of bone in children and young adults, while bone is a common site of metastasis for tumors initiating from other tissues. The heterogeneity, continual evolution, and complexity of this disease at different stages of tumor progression drives a critical need for physiologically relevant models that capture the dynamic cancer microenvironment and advance chemotherapy techniques. Monolayer cultures have been favored for cell-based research for decades due to their simplicity and scalability. However, the nature of these models makes it impossible to fully describe the biomechanical and biochemical cues present in 3-dimensional (3D) microenvironments, such as ECM stiffness, degradability, surface topography, and adhesivity. Biomaterials have emerged as valuable tools to model the behavior of various cancers by creating highly tunable 3D systems for studying neoplasm behavior, screening chemotherapeutic drugs, and developing novel treatment delivery techniques. This review highlights the recent application of biomaterials toward the development of tumor models, details methods for their tunability, and discusses the clinical and therapeutic applications of these systems. [ABSTRACT FROM AUTHOR]

Currently, there are more than 1.5 million knee and hip replacement procedures carried out in the United States. Implants have a 10–15-year lifespan with up to 30% of revision surgeries showing complications with osteomyelitis. Titanium and titanium alloys are the favored implant materials because they are lightweight and have high mechanical strength. However, this increased strength can be associated with decreased bone density around the implant, leading to implant loosening and failure. To avoid this, current strategies include plasma-spraying titanium surfaces and foaming titanium. Both techniques give the titanium a rough and irregular finish that improves biocompatibility. Recently, researchers have also sought to surface-conjugate proteins to titanium to induce osteointegration. Cell adhesion-promoting proteins can be conjugated to methacrylate groups and crosslinked using a variety of methods. Methacrylated proteins can be conjugated to titanium surfaces through atom transfer radical polymerization (ATRP). However, surface conjugation of proteins increases biocompatibility non-specifically to bone cells, adding to the risk of biofouling which may result in osteomyelitis that causes implant failure. In this work, we analyze the factors contributing to biofouling when coating titanium to improve biocompatibility, and design an experimental scheme to evaluate optimal coating parameters. [ABSTRACT FROM AUTHOR]

The field of bioprinting is rapidly evolving as researchers innovate and drive the field forward. This chapter provides a brief overview of the history of bioprinting from the first described printer system in the early 2000s to present-day relatively inexpensive commercially available units and considers the current state of the field and emerging trends, including selected applications and techniques.

The novelty of this study consists of the formulation and characterization of three experimental bleaching gels with hydroxylapatite oxides and fluorine (G28®, G29®, G30®) based on natural fruit extracts compared to the commercial Opalescence 15% (GC, Ultradent, South Jordan, UT, USA). Studies have been conducted on the effect that the experimental bleaching gels have on the color and morphology of different restorative materials (Nanofill®-Schulzer, P.L. Superior Dental Materials GmbH, Hamburg, Germany, and experimental nanocomposites (P11®, P31®, P61®)), immersed in coffee and artificial saliva (for 10 days and 30 days). The study also includes a cytotoxicity test on the gels and nanocomposites after bleaching, with ISO 109993-5 protocols on human dental follicle stem cells. UV-VIS spectroscopy, computerized measurement, and fluorescence spectrometry were used in order to observe the color changes, while the microstructure of the surface was investigated by Scanning Electron Microscopy (SEM). All of the samples immersed in coffee showed the highest color shift in comparison to the baseline. The color difference ΔE values obtained using the two methods (UV-Vis, computerized based on digital images) both after coloring and bleaching, respectively, were different for all four types of nanocomposites stored in the coffee, while no difference was observed in those stored in artificial saliva. The studied experimental gels and nanocomposites had a low cytotoxic effect on cell cultures after bleaching. [ABSTRACT FROM AUTHOR]

The article discusses future uses of the U.S. Department of Defense Joint Pathology Center (JPC) Biorepository. Topics discussed include challenges that complicate transforming the JPC into a modern biorepository, variations in handling specimens, and use of biorepository to obtain uncommon material for research.

In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.

The article presents information on the Federal Biobased Products Preferred Procurement Program, launched by the Ministry of Agriculture in the 2000s. The purpose of this program is to promote the increased purchase of biobased products, which are commercial or industrial products composed of biological products or renewable domestic agricultural materials. The will of the US to reduce the country's dependence to fossil energies and stimulate the consumption of national products is analyzed.

Information about several papers discussed at Fall 2011 Closed Meeting of The Hip Society and the Open Scientific Meeting of The Hip Society held in the U.S. in 2011-2012 is presented. Topics include novel biomaterials, surgical techniques and hip arthroplasty. The symposium highlighted The Hip Society members and the researches done by them on surgical procedures of the hip by surgeons.

The article provides an overview of the development of strategies to prevent possible misuse of toxic chemical and biological materials in 2011. A third meeting was agreed upon by the Seventh Review Conference of the States Parties to the 1971 Biological and Toxic Weapons Convention to promote understanding and effective action on cooperation. Exchanges between Iran and the U.S. have been witnessed in the 16th Conference of the States Parties to the 1993 Chemical Weapons Convention.

In this Editor's Review, articles published in 2014 are organized by category and briefly summarized. We aim to provide a brief reflection of the currently available worldwide knowledge that is intended to advance and better human life while providing insight for continued application of technologies and methods of organ Replacement, Recovery, and Regeneration. As the official journal of the International Federation for Artificial Organs, the International Faculty for Artificial Organs, the International Society for Rotary Blood Pumps, the International Society for Pediatric Mechanical Cardiopulmonary Support, and the Vienna International Workshop on Functional Electrical Stimulation, Artificial Organs continues in the original mission of its founders "to foster communications in the field of artificial organs on an international level." Artificial Organs continues to publish developments and clinical applications of artificial organ technologies in this broad and expanding field of organ Replacement, Recovery, and Regeneration from all over the world. We take this time also to express our gratitude to our authors for offering their work to this journal. We offer our very special thanks to our reviewers who give so generously of time and expertise to review, critique, and especially provide meaningful suggestions to the author's work whether eventually accepted or rejected. Without these excellent and dedicated reviewers, the quality expected from such a journal could not be possible. We also express our special thanks to our Publisher, John Wiley & Sons, for their expert attention and support in the production and marketing of Artificial Organs. We look forward to reporting further advances in the coming years., (Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.)

Ford Motor is continuing its research into the use of natural fibres and bio-based plastics by investigating the use of coconut coir as a composite reinforcement in collaboration with US garden materials company Scotts Miracle-Gro (SMG). The aim is to produce moulded plastic parts that are lighter and more natural-looking while reducing the use of petroleum-based chemicals. [ABSTRACT FROM AUTHOR]