Development Of Biomedical Technologies Research Articles

INTERNATIONAL LEGAL INSTRUMENTS IN THE FIELD OF BIOETHICS AND THEIR IMPACT ON PROTECTION OF HUMAN RIGHTS

Introduction: A rapid development of biomedicine, genetics, pharmacology, transplantation and biotechnology has posed a number of problems to humanity, in particular, with regard to human rights protection in healthcare. These problems solution requires considering the achievements and propositions of biology, medicine, ethics and law. International legal standards in the field of bioethics are of significance in development of national states regulations on bioethics and biotic legislation. Aim: To investigate the impact of international legal instruments in the field of bioethics on protection of human rights. Materials and methods: In the research the international legal instruments and documents in the field of healthcare and bioethics were used. Civilizational, axiological, dialectical, systemic and comparative legal methods as well as systematization, analysis and synthesis were decisive in the research process. Conclusions: Legal instruments in the field of biomedical technologies (directives and regulations) are mainly advisory by nature. In many cases, the problems arising in biotechnology are resolved through establishment and involvement of national supervision bodies: councils (commissions, committees) in bioethics as well as courts. An important role in protection of human rights in the field of biotechnology is played by the ECHR the decisions of which are dynamic, based on the Convention and consideration of national legislations. At the same time, a number of problems remain unresolved because of constant development of biomedical technologies, necessity to take into account the latest achievements and discoveries as well as all types and methods of applying of genetic engineering to humans. In general, insufficient attention is paid to the problems of medical biotechnologies application both at the international and national levels.

КОНСТРУИРОВАНИЕ ЧЕЛОВЕКА В РАКУРСЕ СОВРЕМЕННОЙ БИОМЕДИЦИНЫ: ПАНИЧЕСКИЕ ОЖИДАНИЯ, ЭЙФОРИЯ И ОСТОРОЖНЫЕ ПРОГНОЗЫ

The article attempts to conduct a balanced analysis of the impact of modern biomedical technologies on human corporeality from the perspective of its formation processes. On the one hand, there is a panic mood about the loss of the human proper in man due to the rapid development of biomedical technolo-gies and the construction of human corporeality using them, and as a result, the adoption of measures to prevent radical modification of such corporeality. On the other hand, there are also excessive expecta-tions for modern biomedical technologies that are ultimately, as supposed, to be able to make humans immortal. The task of the author of the article is to show that the scientists involved in biomedical are rather cautious about radical changes in human body, seeing the real risks from such intervention and the lack of clarity about the long-term consequences. At the same time, any interference with a person 's body must be based on respect for and observance of human rights and human dignity.

МАТЕРІАЛИ ДЛЯ РЕКОНСТРУКЦІЇ ТРАВМОВАНОЇ ПЕРЕДНЬОЇ ХРЕСТОПОДІБНОЇ ЗВ’ЯЗКИ У СПОРТСМЕНІВ

Due to various reasons and peculiarities in modern professional sport, the number and severity of injuries are constantly increasing s. Especially important and dangerous are the injuries of the lower extremity, among which not the last place is occupied by the ruptures of the anterior cruciate ligament, one of the most injured ligaments of the knee joint. The peculiarity of injuries of anterior cruciate ligament in athletes is that they, after operations, should return to previous workouts as soon as possible and withstand systematic loads. Classical reconstruction of the anterior cruciate ligament using the patient’s own tissues and the operative treatment of concomitant injuries does not allow for a quick return to professional sports, since it requires prolonged relaxation and rest until the wound is completely healed. Due to the development of biomedical technologies, one of the methods for treating rupture of anterior cruciate ligament was the minimally invasive arthroscopic technique, which provides a lower invasiveness of the intervention and thus accelerates the rehabilitation process. But despite the many modern materials and types of prostheses for creating artificial anterior cruciate ligament, there is a high percentage of unsatisfactory functional results, early and late postoperative complications associated with the implantation of synthetic tissues into the joint. During this research were carried out a comparative analysis of the techniques of reconstruction of the injured anterior cruciate ligament, identification of deficiencies in the techniques and implants that are used now, the formation of basic requirements for their improvement and the development of proposals for special requirements for the treatment of athletes with anterior cruciate ligament . In the “SolidWorks” environment, 2 samples of communication implants were simulated conditionally. Mathematical analysis and comparison of a synthetic implant and an autograft shows that a synthetic anterior cruciate ligament can withstand a load of up to 387 N, while a bundle of human tissues is only 203 N. Considering all the above data, at this stage of development of medical technologies, modern traumatologists should more often consider anterior cruciate ligament reconstructions using minimally invasive arthroscopy and synthetic implants. Since, in accordance with the results, such an approach to treatment can reduce the time of rehabilitation for athletes and help them return to work in the shortest time possible.

Medical Equipment Cost Assessment i n t he Conditions o f Intensive Technological Changes

The purpose of the article is to consider the theoretical and methodological foundations of equipment assessment, in particular, the features of medical equipment assessment. The novelty of the study is associated with the fact that equipment assessment is considered by researchers, as a rule, as a stage in assessing the value of an industrial enterprise, that is, to a greater extent, production equipment is considered. Given the rapid development of biomedical engineering, the novelty of the study is related to the consideration of the features of medical equipment assessment. The article substantiates the relevance of medical equipment assessment and analyzes the use of different approaches to medical equipment assessment. Based on the analysis of scientific literature and expert survey, the characteristics of different approaches to medical equipment assessment are presented; cost factors, as well as advantages and disadvantages of various assessment methods, are indicated.

Facile Method for Fabricating Microfluidic Chip Integrated with Microwell Arrays for Cell Trapping.

With the development of biomedical technology, personalized diagnosis and treatment at the single-cell level are becoming more important in the medical field. As one of the most powerful tools, microfluidic chips have shown significant potential for various applications related to cell separation, cell proliferation, and cell behavior analysis. However, fabricating microfluidic devices requires complicated procedures and high-cost equipment. In this study, an optofluidic maskless lithography method was proposed for rapid fabrication of microfluidic devices integrated with microwells. Through the use of this approach, microwells can be on-line designed and the exposure patterns can be modulated. Single or multi polystyrene microspheres were successfully trapped by using the designed microwells. The capture of MCF-7 cells and cell arrays indicated that the microfluidic devices fabricated in the present study can be applied for cell research.

Patenting of Human Genes: The United States, Canada and Australia Case Law

The paper is a review of the case law of the United States of America, Canada and Australia, in which an attempt is made to answer the question on possibility of human gene patenting. The paper substantiates the relevance of this issue, examines the ethical aspects of gene patenting. The author analyzes the landmark and most significant cases from the point of view of the development of patent law of foreign countries: Diamond v. Chakrabarty (USA), Association for Molecular Pathology v. Myriad Genetics (USA), Myriad v. Cancer Voices (Australia), The Children’s Hospital of Eastern Ontario (CHEO) v. Transgenomic (Canada). In the analysis, the author gives special attention to the arguments and conclusions of judicial institutions regarding the patentability of human genes. A conclusion is drawn regarding the continuity and possible harmonization of legislation and judicial practices of both the states mentioned in the paper and countries that have just embarked on the development of biomedical technologies.

Abstract CT220: Expansion into multiple institutions for training in the use of the LUM Imaging System for intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer

Abstract Background: Obtaining tumor-free margins is critical for local control in breast conserving surgery. Currently, 20-40% of lumpectomy patients have positive margins that require surgical re-excision; this is a significant burden for patients, surgeons and the healthcare system. Therefore, it is of paramount importance that all cancer be resected from the tumor bed during lumpectomy surgery. The LUM Imaging System consists of a fluorescence-based imaging agent, a hand-held wide-field detector (LUM Imaging Device) used to image the surgical cavity walls intraoperatively in real-time after the resection of the main lumpectomy specimen, and a proprietary tumor detection algorithm that highlights regions in the tumor bed suspected to contain residual cancer. Methods: This multi-site clinical study is designed to refine the tumor detection algorithm developed in previous studies by correlating images generated by the LUM Imaging System with histopathology results. This is a prospective, interventional feasibility study and is an introductory arm to a pivotal study which will evaluate the safety and efficacy of the LUM Imaging System in reducing the positive margin rate during standard of care lumpectomies. Up to 250 adult female breast cancer patients undergoing lumpectomies are being enrolled at sixteen medical centers across the US. The novel imaging agent, LUM015, is injected into all enrolled subjects prior to their lumpectomy procedure. Subjects undergo the standard of care lumpectomy followed by intraoperative use of the LUM Imaging System which helps guide surgeons in identifying potential residual tumor tissue. The primary objective is to assess performance characteristics of the LUM Imaging System and to fine-tune the tumor detection algorithm. A secondary objective is to develop and refine the process of implementing the LUM Imaging System into institution-specific workflows during lumpectomies. A comprehensive process to evaluate the LUM Imaging System has been implemented and will be reported. This study is being conducted under an Investigational Device Exemption (IDE) approved by the FDA. To date, 72 subjects have been imaged using the LUM Imaging System. Successful implementation of standardized tissue collection, naming conventions, and LUM Imaging System training is intended to improve the quality and integrity of the data collected in the upcoming pivotal clinical trial to evaluate the safety and efficacy of the LUM Imaging System. This study is partially funded by a grant from the National Cancer Institute (award 1R44CA211013) to support biomedical technology development and Lumicell Inc. and is registered on Clinical Trials.gov as NCT03321929. Citation Format: Kate Smith, Jorge M. Ferrer, Barbara L. Smith, E. Shelley Hwang, Kelly K. Hunt, Daleela G. Dodge, Stephen E. Karp, Stephanie A. Valente, Irene L. Wapnir, Lynne P. Clark, David R. Carr, Peter D. Beitsch, Donna L. Dyess, Beth-Ann Lesnikoski, Peter W. Blumencranz, Nayana S. Dekhne, Linsey P. Gold, Anees Chagpar, Katherine Kacena, Livia Gjylameti, Felix Geissler. Expansion into multiple institutions for training in the use of the LUM Imaging System for intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT220.

Cell-Based Fish: A Novel Approach to Seafood Production and an Opportunity for Cellular Agriculture

Cellular agriculture is defined as the production of agricultural products from cell cultures rather than from whole plants or animals. With growing interest in cellular agriculture as a means to address the public health, environmental, and animal welfare challenges of animal agriculture, the concept of producing seafood from fish cell- and tissue-cultures is emerging as a means to address similar challenges with industrial aquaculture systems and marine capture. Cell-based seafood - as opposed to animal-based seafood - can combine developments in biomedical engineering with modern aquaculture techniques. Biomedical engineering developments such as closed-system bioreactor production of land animal cells create a basis for large scale production of marine animal cells. Aquaculture techniques such as genetic modification and closed system aquaculture have achieved marked gains in production that can pave the way for innovations in cell-based seafood production. Here, we present the current state of innovation relevant to the development of cell-based seafood across multiple species as well as specific opportunities and challenges that exist for advancing this science. The authors find that the physiological properties of fish cell- and tissue- culture may be uniquely suited to cultivation in vitro. These physiological properties, including hypoxia tolerance, high buffering capacity, and low-temperature growth conditions, make marine cell culture an attractive opportunity for scale production of cell-based seafood; perhaps even more so than mammalian and avian cell cultures for cell-based meats. This, coupled with the unique capabilities of crustacean tissue-friendly scaffolding such as chitosan, a common seafood waste product and mushroom derivative, presents great promise for cell-based seafood production via bioreactor cultivation. To become fully realized, cell-based seafood research will require more understanding of fish muscle culture and cultivation; more investigation into serum-free media formulations optimized for fish cell culture; and bioreactor designs tuned to the needs of fish cells for large scale production.

Review of comprehensive intervention by hand rehabilitation robot after stroke

Using intelligent rehabilitation robot to intervene hand function after stroke is an important physical treatment. With the development of biomedical engineering and the improvement of clinical demand, the comprehensive intervention of hand-function rehabilitation robot combined with new technologies is gradually emerging. This article summarizes the hand rehabilitation robots based on electromyogram (EMG), the brain-computer interface (BCI) hand rehabilitation robots, the somatosensory hand rehabilitation robots and the hand rehabilitation robots with functional electrostimulation. The advantages and disadvantages of various intervention methods are discussed, and the research trend about comprehensive intervention of hand rehabilitation robot is analyzed.

Nuts and Bolts: Microfluidics for the Production of Biomaterials

AbstractNanotechnology holds the promise of bringing revolutionary therapeutic strategies into the clinic. However, an enormous fraction of the currently proposed nanotechnology‐based therapies suffers from lack of reproducibility, complexity, high costs, and scale‐up‐related issues. For these reasons, the research community is moving toward the miniaturization of biomaterials and fabrication methods. Customizable microfluidic‐based products have gained tremendous relevance in the development of biomedical technologies. This review provides an overview of different materials that can be used for the fabrication of microfluidic devices, as well as the other parameters influencing the production of biomaterials and biosensors. Moreover, several advanced microfluidic‐based technologies that are designed to overcome the current challenges of cancer, immunotherapy, and diabetes therapy, among others are described. Then, the pros and cons of microfluidics as alternative to conventional preparation methods, and the challenges of translating this technique to an industrial context are highlighted. Overall, microfluidic technologies and their accessibility to the research community offer a set of exciting opportunities to bridge the development of innovative therapies and their commercialization in the foreseeable future.

Защита конституционного права на жизнь и достоинство ребенка на пренатальной стадии развития в условиях совершенствования биомедицинских технологий

Защита конституционного права на жизнь и достоинство ребенка на пренатальной стадии развития в условиях совершенствования биомедицинских технологий

Progress in laboratory detection of anti-neutrophil cytoplasmic antibodies

Along with the rapid development of biomedical technology and the clinical application of anti-neutrophil cytoplasmic antibody (ANCA), the detection of ANCA by indirect immunofluorescence (IIF) and the detection of specific autoantibodies of ANCA by various immunological methods have also been developed, which promoted the standardization of ANCA′s laboratory testing procedures. These advances have brought new opportunities and challenges to ANCA′s laboratory testing technology and its clinical application. (Chin J Lab Med, 2018, 41: 905-908) Key words: Antibodies, antineutrophil cytoplasmic; Autoantibodies; Fluorescent antibody technique, indirect; Clinical laboratory techniques

The BIG Data Center's database resources

Omics data in life and health sciences are of fundamental significance for scientific research and biomedical technology development. However, there is yet to be a platform for biological data management and sharing in China, making it difficult to meet the development needs of biomedical and related fields and consequently leading to severe issues in big data management, sharing and translation. To address these issues, Beijing Institute of Genomics (BIG) of Chinese Academy of Sciences founded the BIG Data Center (BIGD) in 2016, which is dedicated to establish a biological big data management platform and multi-omics databases, with a particular focus on national population healthcare and important strategic biological resources. In this paper, we describe core database resources in BIGD, including GSA (Genome Sequence Archive), GWH (Genome Warehouse), GVM (Genome Variation Map), GEN (Gene Expression Nebulas), MethBank (Methylation Bank), BioCode and Science Wikis. Taken together, all these resources provide a series of services for data deposition, integration and sharing, laying solid foundations for enhancing national biological science data management and further promoting the construction of national bioinformatics center.

Research progress of transplantation of marrow mesenchymal stem cells for the treatment of traumatic brain injury

At present, traumatic brain injury (TBI) is one of the major diseases that threaten human lives and its morbidity is continuously increasing, with high disability rate and mortality rate. With the rapid development of biomedical technology, stem cells transplantation in the treatment of TBI has become a hot topic. In animal experiments and clinical studies, bone marrow mesenchymal stem cells (MSCs) are the most widely used, and have become the most important seed cells in nerve tissue engineering. In this paper, we reviewed the mechanisms of MSCs transplantation in the treatment of TBI, the transplantation method, the evaluation methods after transplantation and the progress of clinical research. Key words: Marrow mesenchymal stem cells; Transplantation; Traumatic brain injury

A multi-omics annotation platform for rare disease to benefit precision medicine

In recent years, with the development of biomedical technology as well as the concept of “precision medicine”, much effort has been devoted to relevant preclinical and clinical research, leading to the molecular study of diseases. Meanwhile, the diagnosis and treatment of diseases are becoming more and more personalized. With low incidence, complicated pathogenesis and large difficulty in treatment, rare diseases have aroused public awareness. Latest studies have found that detailed clinical phenotype is the keystone of deciphering genes and precise treatment for rare diseases. To develop precision medicine and to improve the diagnosis and treatment of rare diseases, we built a standardized Chinese platform named Encyclopedia of Rare Disease Annotation for Precision Medicine (eRAM, www.unimd.cn/eram ), which systematically integrates the clinical manifestations and molecular annotations of rare diseases and provides new connections among rare diseases. At present, the platform contains a rich annotation for 15,942 rare diseases, including 6,147 human disease-related phenotypes, 31,661 mammalian phenotypes, 10,202 symptoms from UMLS, 18,815 genes, and 92,580 genotypes. eRAM provides enriched disease multi-level annotations, as well as connections among rare diseases. Moreover, additional functions are provided, including disease prediction and EMR (electric medical records) submission for users, providing information about rare disease mechanisms and assisting clinicians to make accurate diagnosis and treatment decisions for rare diseases.

¿Quién Es (R)? Una consideración en Torno a la identidad a partir del Primer Trasplante de Cabeza en humanos

El desarrollo actual de las tecnologías biomédicas ha contribuido extraordinariamente al bienestar de la humanidad, por lo que anhelamos que continúe haciéndolo. No obstante, ese mismo desarrollo ha producido nuevos riesgos para la integridad y lo que asumimos como la identidad del ser humano al situarlo como punto medular en los debates públicos sobre la ética, la estética y la salud. Su cuerpo, que se explicita como un territorio de disputa estratégico, es el lugar donde se expresan las vastas transformaciones tecnocientíficas, logrando convertirse en parte esencial de los dilemas bioéticos actuales que abarcan la vida humana desde su nacimiento y su desarrollo hasta su muerte. Entre estos debates podemos destacar las polémicas acontecidas alrededor de temas como el aborto, la eutanasia, la procreación asistida, la manipulación genética, y la primera anastomosis de cabeza en humanos. El siguiente artículo realiza una reflexión ético- filosófica en torno a la noción de identidad implícita a partir del primer trasplante de cabeza en humanos. Para ello, se presenta de forma clara y sucinta los aspectos históricos que antecedieron al primer intento quirúrgico de trasplantar una cabeza humana, seguido a ésto se trae a colación las particularidades técnicas del procedimiento y, por último, se hace hincapié en la preocupación por el hombre y el riesgo de ser modelado a imagen de los objetos técnicos

Abstract CT166: Expansion into multiple institutions for training in the use of the LUM Imaging System for intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer

Abstract Clinical need: Obtaining tumor-free margins is critical for local control in breast conserving surgery. Currently, 20-40% of lumpectomy patients have positive margins that require surgical re-excision which is a burden for patients, surgeons and the healthcare system. Therefore, it is of paramount importance that all cancer be resected from the tumor bed during lumpectomy surgery. Background: The LUM Imaging System consists of a fluorescence-based imaging agent, LUM015, a hand-held wide-field detector (LUM Imaging Device) used to image a tumor bed cavity in real-time, and a proprietary tumor detection algorithm that highlights regions of a tumor bed suspected to contain residual cancer. The LUM Imaging System may be used to scan the surgical cavity walls intraoperatively after the resection of the main lumpectomy specimen. Trial Objectives and Methodology: This multi-site study is designed to validate the process of implementing the LUM Imaging System into institution-specific workflows during lumpectomies and to correlate images generated by the LUM Imaging System with histopathology results. This study is a prospective, interventional feasibility study and is an introductory arm to a pivotal study which will evaluate the safety and efficacy of the LUM Imaging System in reducing the positive margin rate in excised tissue during standard of care lumpectomies. Up to 165 adult female breast cancer patients undergoing lumpectomies are being enrolled at up to eleven medical centers across the US. This study is being conducted under an Investigational Device Exemption granted by the FDA. This study evaluates the use of the LUM Imaging System within the scope of the study protocol, while maintaining institutional standards on maintaining specimen tissue orientation and nomenclature. Surgeons record images of in-vivo tissue and ex-vivo tissue to measure the ratio of fluorescent intensity between the in-vivo and ex-vivo images to verify that consistent tissue contact is made during lumpectomy cavity scanning. A comprehensive process to evaluate LUM System operation is implemented and will be reported. The novel imaging agent, LUM015, is injected into all enrolled subjects and safety data is being collected. Discussion: Successful implementation of standardized tissue collection, naming conventions, and LUM Imaging System training is intended to improve the quality and integrity of the data collected in the upcoming Pivotal clinical trial to evaluate the safety and efficacy of the LUM Imaging System. This System is also currently being evaluated in other cancer indications including gastrointestinal cancers, prostate cancer and brain cancer. This study is funded by a grant from the National Cancer Institute to support biomedical technology development. Citation Format: Jorge M. Ferrer, Shelly Hwang, Kelly Hunt, Daleela Dodge, Anees Chagpar, Stephen Grobmyer, Stephen Karp, Stephanie Valente, Irene Wapnir, Kate Smith, Elena Ramirez, Thomas Bischof, David Strasfeld, David Lee, Barbara Smith. Expansion into multiple institutions for training in the use of the LUM Imaging System for intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr CT166.

Legal Progress in the Protection of the Rights and Interests of Human Subjects in Biomedical Research in China

The rapid development of biomedical technology in China requires much research and a large number of human subjects have emerged in response. Chinese government has been sparing no efforts in protecting the rights of human subjects by the law and has made further achievements in 2016. This article finds that the laws are being improved, the ethical principles have been growing clearer, the validity of informed consent has been better guaranteed and the gap that the law fails to fill has been compensated for in legislation in China. Though legislative technique and legislation in this field need improvement, the legal guarantee of the rights of subjects is promising.

Pravni problemi definisanja polja pravne zaštite nondum conceptus-a

Legal science and practice has long been interested in the protection of an unborn life, both the one conceived in vivo, naturally, and the one conceived in vitro, by means of artificial insemination. Due to the rapid development of biomedical technology, we are becoming increasingly familiar with risk factors for a child’s existence that could leave it with physical and psychological consequences, such as serious genetic diseases or infectious diseases that a mother could transfer to her child through her blood at the very moment of conception. Since such risk factors can be prevented only before conception, the only way to preclude potential damage is to consider the child’s interests before it is conceived. That is why it is important to establish the status of an unconceived person, nondum conceptus. Even though it exists as one of three legally recognized stages in relation to the occurrence of a person’s legal capacity, there are numerous dilemmas about what this subject actually represents, its characteristics and how it functions within the law. The author concludes that the status of nondum conceptus requires analysis beyond the existing limits of the traditional comprehension of natural persons’ legal capacity and that it also calls for defining new concepts and constructs for subjects such as unconceived humans.

The BioDARPA Concept

The dramatic development of biomedical technologies inevitably raises a question of the increasing gap between basic biomedical discoveries and their use in clinical practice. Created in 1958 with the same purpose, DARPA has had to bridging the gap in defense technologies (mostly in rocket and radar sciences). Today we can talk about the relevance of the idea of biomedical DARPA (BioDARPA) as a concept of organizational design for priority research and development of emerging biotechnologies.