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Autore: Grafiati

Pubblicato: 22 giugno 2024

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1

Szabłowska-Gadomska, Ilona, Leonora Bużańska e Maciej Małecki. "Stem cell properties, current legal status and medical application". Postępy Higieny i Medycyny Doświadczalnej 71 (31 dicembre 2017): 0. http://dx.doi.org/10.5604/01.3001.0010.7733.

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Stem cells due to their unique properties of self-renewal and differentiation play a potential role in the process of damaged tissue repair. Isolated from the inner cell mass of the blastocyst have pluripotential properties and are called embryonic stem cells (ESC). Pluripotential stem cells can be also generated from the differentiated cells by the process of reprogramming and are called induced pluripotent stem cells (iPSC). Stem cells isolated from tissues (somatic or adult stem cells) are more restricted in their differentiation potential and referred as multipotent. The rapid rise in number of clinical trials using somatic stem cells is due to their proved in basic and preclinical studies therapeutic safety and paracrine properties to modulate microenvironment. Increased translation to the clinic of studies using adult stem cells provide hope for patients with diseases for which traditional medicine is powerless .or ineffective. On the other hand progress in iPSC technology allows to derive disease models and personalize future clinical diagnosis and treatment. This paper will focus on characteristics of stem cells, potential application in regenerative medicine, and the current legal status of cell therapy.

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Spranger, Tade Matthias. "Legal Status and Patentability of Stem Cells in Europe". Biotechnology Law Report 21, n. 2 (aprile 2002): 105–12. http://dx.doi.org/10.1089/07300310252962019.

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TSANG, L. "Legal and ethical status of stem cells as medicinal products". Advanced Drug Delivery Reviews 57, n. 13 (12 dicembre 2005): 1970–80. http://dx.doi.org/10.1016/j.addr.2005.08.005.

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Lebacqz, Karen. "Stumbling on status: Abortion, stem cells, and faulty reasoning". Theoretical Medicine and Bioethics 33, n. 1 (31 dicembre 2011): 75–82. http://dx.doi.org/10.1007/s11017-011-9205-x.

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Пестрикова, Анастасия. "THE PROBLEMS OF DETERMINING THE LEGAL STATUS OF THE EMBRYO AND PARTHENOGENETIC STEM CELLS IN LIGHT OF THE DEVELOPMENT OF GENETIC ENGINEERING". Rule-of-law state: theory and practice 16, n. 2 (1 febbraio 2020): 69–80. http://dx.doi.org/10.33184/pravgos-2020.2.7.

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At the present stage of the development of genetic engineering, the question is raised about the legal status of a human embryo in connection with the commercialization and patenting of parthenogenetic embryonic stem cells. Aim: the article considers the main directions of developing criteria for distinguishing between cellular substances included in the definition of a human embryo, taking into account the latest achievements in the field of genetic engineering and judicial practice of the European Union. Methods: the author uses a comparative analysis of the main scientific achievements in the field of genetic engineering and emerging international practice of legal research in this field. Results: the author proves the importance of distinguishing between the definition of the concept of an embryo in terms of biology and genetics, and the consolidation of legal status and the need for legal protection, in order to avoid abuse of law and evasion of law in the commercial use of human stem cells and human embryos.

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Osadolor, I. O. "The status of nasciturus in the Mexican legal system and ITS relationship with embryonic stem cells". Cytotherapy 19, n. 5 (maggio 2017): S87. http://dx.doi.org/10.1016/j.jcyt.2017.02.155.

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Steinbock, Bonnie. "The Morality of Killing Human Embryos". Journal of Law, Medicine & Ethics 34, n. 1 (2006): 26–34. http://dx.doi.org/10.1111/j.1748-720x.2006.00005.x.

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Embryonic stem cell research is morally and politically controversial because the process of deriving the embryonic stem (ES) cells kills embryos. If embryos are, as some would claim, human beings like you and me, then ES cell research is clearly impermissible. If, on the other hand, the blastocysts from which embryonic stem cells are derived are not yet human beings, but rather microscopic balls of undifferentiated cells, as others maintain, then ES cell research is probably morally permissible. Whether the research can be justified depends on such issues as its cost, chance of success, and numbers likely to benefit. But this is an issue for any research project, not just ES cell research. What makes the debate over ES cell research controversial is that it, like the debate over abortion, raises “questions that politicians cannot settle: when does human life begin, and what is the moral status of the human embryo?” This paper looks at several theories of moral status and their implications for embryo research.

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Sivaraman, Purnima. "An Empirical Study on the Legal Issues Surrounding Embryonic Stem Cell Research in India". Journal of Legal Studies & Research 08, n. 05 (2022): 164–81. http://dx.doi.org/10.55662/jlsr.2022.8504.

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The discovery of stem cells particularly embryonic stem cells with its possible clinical application has generated great curiosity amongst medical professionals and general public. Embryonic stem cell research has become a challenging issue for biomedical scientists, policy makers and regulatory bodies. The key controversial issue is the determination of moral and legal status of the embryo as embryo stem cell research involves retrieving embryonic tissue from spare embryos leading to their destruction. This embryo that has the full capacity to develop into a human being is sacrificed for the benefit of others. Global regulations monitoring stem cell research are also troubled with similar ethical and moral issues associated with it. The main source of embryonic tissue is the spare or supernumerary embryos created during infertility treatment by artificial reproductive techniques (ART). Sadly, in absence of regulatory provisions to govern them, the field of ART is open for all forms of medical malpraxis bearing direct implications on embryonic stem cell research. This article is an attempt to seek clarity on the concept of embryonic stem cell research and contentious issues associated with it. This is a non-doctrinal study. The researcher has depended on both primary and secondary data. Random sampling has been used to collect the primary data which has been analysed using Frequencies, Chi-Square test and Crosstab method. Secondary data like books, websites, journals and case laws have also been referred to provide a comprehensive and holistic approach towards the study.

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A.S., Herasymenko, e Kultenko V. P. "ETHICS OF THE USE OF EMBRYONIC STEM CELLS IN SCIENCE AND MEDICINE". HUMANITARIAN STUDIOS: PEDAGOGICS, PSYCHOLOGY, PHILOSOPHY 12, n. 3 (novembre 2021): 81–86. http://dx.doi.org/10.31548/hspedagog2021.03.081.

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Ethical dimensions of biotechnology problems are studied, in particular: ethics of use of embryonic stem cells in science and medicine; the responsibility of researchers for the consequences of their actions; the ethics of using animals in biotechnological research to solve human problems and ensure human health; the limits of human intervention in the genome of living beings; problems of maintaining the balance of the ecosystem; moral and legal status of the embryo, which is used as a resource material in biotechnological research. The attitude of different religions to biotechnological research and experiments with embryonic stem cells is also considered. The question of the impossibility of obtaining economic benefits from the human body, including the unborn and its parts, is becoming more acute.

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Kossow, Sydney. "Creating a United Front: Harmonizing the United States Regulatory Policies Surrounding Human Embryonic Stem Cell Research". SMU Science and Technology Law Review 25, n. 2 (2022): 295. http://dx.doi.org/10.25172/smustlr.25.2.7.

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Stem cell therapy is an imperative development in science and medicine that is heavily regulated worldwide. With the potential to cure illnesses, help understand disease development, and advance regenerative medicine, a harmonized regulatory policy is crucial to capitalize on the benefits of stem cells. This article examines an important topic of discussion surrounding stem cell therapy and research: the political debate on how and when embryonic stem cells can be used. In addition to examining ethical challenges, this article discusses the legal challenges surrounding using embryonic stem cells to inform regenerative therapies. Specifically, this article will examine the National Institute of Health’s Guidelines for Human Stem Cell Research and the historic avenues of federal and state legislation to regulate the use of these cells in research. This article discusses the internal and external inconsistencies of the United States’ current regulation of embryonic stem cells and how the divide between states is problematic for the United States’ completive stance in developmental science and medicine. Finally, this article contemplates a cohesive regulatory system influenced by individual states and other countries that currently lead the medical field, to form a united front in approaching the use of stem cells.

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Streiffer, Robert. "Chimeras, Moral Status, and Public Policy: Implications of the Abortion Debate for Public Policy on Human/Nonhuman Chimera Research". Journal of Law, Medicine & Ethics 38, n. 2 (2010): 238–50. http://dx.doi.org/10.1111/j.1748-720x.2010.00484.x.

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Moral status is the moral value that something has in its own right, independently of the interests or concerns of others. Research using human embryonic stem cells (hESCs) implicates issues about moral status because the current method of extracting hESCs involves the destruction of a human embryo, the moral status of which is contested. Moral status issues can also arise, however, when hESCs are transplanted into embryonic or fetal animals, thereby creating human/ nonhuman stem cell chimeras (“chimeras” for short). In particular, one concern about chimera research is that it could confer upon an animal the moral status of a normal human adult, but then impermissibly fail to accord the animal the protections it merits in virtue of its enhanced status. Understanding the public policy implications of this ethical conclusion is complicated by the fact that certain views about the moral status of the embryo cannot legitimately be used to justify public policy decisions. Arguments like those employed in the abortion debate for the conclusion that abortion should be legally permissible even if abortion is not morally permissible also support, to a more limited degree, a liberal policy on hESC research involving the creation of chimeras.

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Ruhela, Naman, Rohit Bhatia, Ananya Parashar, Pawan Kumar Jaggi e Arti R. Thakkar. "Comparative Regulatory Requirements for the Stem Cells and Stem Cells Based Products in India, United States and European Union". Current Drug Therapy 16, n. 5 (ottobre 2021): 381–92. http://dx.doi.org/10.2174/1574885516666211005120320.

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: Stem cells are the unique cells in the body which have the capability to divide continuously and differentiate into various other kinds of cells and tissues. This work represents the issues and challenges in the stem cells and stem cells-based products regulations and compares the related guidelines in India, the USA, and the EU. In India, stem cells (SCs) and stem cells-based products (SCBP) are considered as ‘drugs’ as per the recent guidelines and amendments in the Indian Drugs and Cosmetics Act with a view to streamline the regulatory framework for advanced research. The United States Food and Drug Administration (USFDA) and the Centre for Biologics Evaluation and Research (CBER) in America regulate stem cells and stem cell therapies-based products. European regulation 1394/2007 was issued in 2008, which lays down the legal framework for cell- derived medicinal products in Europe. In the present review, India, USA and EU guidelines have been compared and critically evaluated. After the comparison of the drug approval process in India, the USA and the EU, it was found that India and the USA both have a single registration process for the approval of the drug products, while the EU has multiple processes. The product approval time is more in the USA. EU charges more fees compared to the other countries. Previously, India was following paper CTD formats, but now India is following eCTD, which is also followed by US and EU countries.

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Isasi, Rosario, e Bartha Knoppers. "Mind the Gap: Policy Approaches to Embryonic Stem Cell and Cloning Research in 50 Countries". European Journal of Health Law 13, n. 1 (2006): 9–25. http://dx.doi.org/10.1163/157180906777036328.

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AbstractThis article provides an overview of (I) the moral and legal status of the human embryo and of the (II) regulatory approaches to embryonic stem cells and cloning research by comparing the regulatory frameworks of 50 countries. The major goal of this study is to provide and analytical understanding of the policy landscape around the globe, with an aim to contribute to worldwide policy debates. The comparison of these policies underscores the hurdles that scientific consortia involving international jurisdictions and policy frameworks have to confront, as well as the challenges facing the international harmonization of such policies.

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Kuz’menko, G. N., O. F. Lobazova e O. A. Evreeva. "Modern ethical, legal and institutional framework of biomedical cell technologies development in the People’s Republic of China". Kazan medical journal 97, n. 1 (15 febbraio 2016): 108–13. http://dx.doi.org/10.17750/kmj2016-108.

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New Chinese medicine democracy almost did not affect the traditional bases of the medical code, a certain pragmatism in relation to the moral component was preserved in it. Interest in the individual’s health was originally inscribed in the worldview code of the Chinese nation, which understands the best way of a living being existence as a harmony of the natural elements, energy states in it. General pantheistic basis, hidden or explicit anthropological naturalism of religious and philosophical views, which are traditional for China, Confucianism, Taoism and Buddhism form had a corresponding impact on medical ethics. Millennium beginning was expressed in the focusing of the government attention on the ethical and legal support of biotechnologies, in particular biomedical cell technologies. Government set targets to accelerate the implementation of the governmental scientific and technological specific projects in innovation areas. As a result of special solutions development by the China’s Communist Party, government emphasized the formation of developed system of «high technology zones», including biotechnoparks. Strict regulatory requirements for production, storage and use of stem cells different types, which have been adopted by the government of the People’s Republic of China in recent years, objectively allow China to sell products and services in the field of cell technology not only domestically but also abroad. If the business component of those services types, which are currently formed in the Chinese industry of biomedical cell technologies, are considered, three models can be distinguished: the first model is related to stem cells collection and storage; the second model includes stem cells production and research; the third business model - enterprises directly engaged with stem cell transplantation.

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Acosta, Nefi D., e Sidney H. Golub. "The New Federalism: State Policies Regarding Embryonic Stem Cell Research". Journal of Law, Medicine & Ethics 44, n. 3 (2016): 419–36. http://dx.doi.org/10.1177/1073110516667939.

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Stem cell policy in the United States is an amalgam of federal and state policies. The scientific development of human pluripotent embryonic stem cells (ESCs) triggered a contentious national stem cell policy debate during the administration of President George W. Bush. The Bush “compromise” that allowed federal funding to study only a very limited number of ESC derived cell lines did not satisfy either the researchers or the patient advocates who saw great medical potential being stifled. Neither more restrictive legislation nor expansion of federal funding proved politically possible and the federal impasse opened the door for a variety of state-based experiments. In 2004, California became the largest and most influential state venture into stem cell research by passing “Prop 71,” a voter initiative that created a new stem cell agency and funded it with $3 billion. Several states followed suit with similar programs to protect the right of investigators to do stem cell research and in some cases to invest state funding in such projects. Other states devised legislation to restrict stem cell research and in five states, criminal penalties were included. Thus, the US stem cell policy is a patchwork of multiple, often conflicting, state and federal policies.

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YIN, Jie. "“禮”而非“理”——為何應以儒家視角看待胚胎幹細胞研究問題". International Journal of Chinese & Comparative Philosophy of Medicine 9, n. 2 (1 gennaio 2011): 11–26. http://dx.doi.org/10.24112/ijccpm.91503.

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LANGUAGE NOTE | Document text in Chinese; abstract also in English.現代醫學中的胚胎幹細胞研究引發極具爭議性的倫理問題。西方社會本著崇尚理性的精神，探討胚胎幹細胞研究多從合法性和合理性的角度出發。至於中國文化，理性不是唯一的工具，甚至從來不曾用於制定規範的基準線。如儒家對於倫理學問題，便主張採取以仁為本、以禮為綱的態度。本文試圖以胚胎幹細胞之問題為例，分析並論證這種觀點，即儒家視角可能是我們看待倫理學問題另一較為有效之方法。儒家“禮”的觀念既是個人修為的標準、社會習俗和輿論的指引，也是立法的基礎，並且是倫理與律法相協調之根本。在當代社會科技飛速發展的形勢下，儒家傳統觀念仍因其關涉人之根本問題的本質而擁有強大的生命力。Stem cell research is a controversial issue in bioethical debates because, although stem cells have great therapeutic potential, such research involves the creation, use, and destruction of human embryos. Some debates center on the question of whether embryonic stem cells have a moral status. This paper contends that in the West, the discussion on whether research on embryonic stem cells is ethically acceptable is usually approached from the perspective of reason or rationality, as one sees in legal provisions pertaining to the issue. Very often, (instrumental) rationality is taken as the primary source for moral and legal justification. The paper analyzes the Kantian notion of “moral status,” pointing out the limits of this way of thinking.Chinese philosophy, especially Confucianism, does not merely employ rationality as a means for making moral judgments. The Confucian idea of “li” (appropriateness), which aims at achieving propriety in one’s roles and relations, can be used to deal with specific ethical difficulties. Because stem cell research deals with humans and human relationships, it goes beyond legal permission or issues such as informed consent. This paper attempts to show that a rational approach may not always work for people whose moral lives and ideals are embedded in Chinese culture. It does not argue that Confucian ethical views can resolve all moral controversies, particularly those raised by modern medical technologies. It does, however, argue that Confucian moral theory and ethical practice should be reconstructed to tackle the current moral dilemmas concerning bioethical issues.DOWNLOAD HISTORY | This article has been downloaded 89 times in Digital Commons before migrating into this platform.

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О. L., Lvovа, e Ivaniv I. R. "The moral and legal foundations of bioethics in the context of human rights: legal theory and international practice". Almanac of law: The role of legal doctrine in ensuring of human rights 11, n. 11 (agosto 2020): 327–33. http://dx.doi.org/10.33663/2524-017x-2020-11-55.

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Modern processes of globalization taking place in the field of law are a great challenge to the idea of human nature, which is recognized in Ukraine as the highest social value, as well as to the concept and essence of law itself. In our opinion, this is a threat on a global scale and necessitates the search for an adequate response to the threat from the scientific and technical process in the field of biomedicine, both for the natural (physical) existence of man and the preservation of his moral identity. In fact, these foundations have become the prerequisites for the development of the science of bioethics. Bioethics studies controversial and ambiguous issues and proposes a humanitarian examination, which aims to assess the arguments in favor of the development of human creativity, health and prevention of premature death, and arguments in favor of preserving human identity in its spiritual and physical integrity. The purpose of the article is to study the essence of controversial bioethical problems, the reasons for their occurrence and prospects for solving these problems. human, manipulation of stem cells and others. Bioethical issues usually include the ethical issues of abortion; contraception and new reproductive technologies (artificial insemination, surrogacy); conducting experiments on humans and animals; obtaining informed consent and ensuring patients' rights; determination of death, suicide and euthanasia; problems in relation to dying patients (hospices); demographic policy and family planning; genetics (including problems of genome research, genetic engineering and gene therapy); transplantology; health equity; human cloning, manipulation of stem cells and others. These issues related to the progress of genetics, genomics, pharmacology, transplantation, biotechnology, cloning are becoming increasingly important as a direction of international law in the context of ensuring and protecting human rights. IN legal literature indicates the formation of "biolaw", "bioethical legislation", "bioethical human rights". Thus there is a combination of possibilities and purposes of medicine and law. In our article, we have explored only some of these issues, which are currently the most relevant, debatable, and therefore require detailed analysis. These include, in our view, the legal status of the embryo, therapeutic and reproductive cloning, abortion, the use of assisted reproductive technologies and organ transplantation. In order to adequately cover these issues, we compare the rules of law governing these debatable issues with the views of church representatives and scholars on these issues. We also proposed changes that need to be made to the legislation of Ukraine so that the rules of law governing these issues meet the moral and ethical principles. As a conclusion is marked, that as bioethics as science dealing with survival combines in itself biological knowledge and general human values, then it is possible to consider natural human rights, her honour and dignity morally-legal principles of bioethics, a self right and law must become on defence of that, in particular, with the aim of providing of natural (physical) existence of man, and maintenance of her moral identity. Keywords: human rights, moral, bioethics, abortion, reproductive technologies, cloning.

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Baylis, Françoise, e Timothy Krahn. "The trouble with embryos". Science & Technology Studies 22, n. 2 (1 gennaio 2009): 31–54. http://dx.doi.org/10.23987/sts.55238.

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In an effort to quell ongoing debate about the ethics of human embryonic stem cell (hESC) research, there have been concerted efforts to develop ethical standards for both embryo and hESC research and to entrench these standards in law. Surprisingly these efforts have not included efforts at standardizing the meaning of the pivotal term ‘embryo’. This paper reviews the legal framework for embryo research in the United Kingdom, the United States and Germany and highlights the absence of any agreed upon standard for what counts as a human embryo. This is an important lacuna, especially in light of the most recent advances in stem cell research involving the reprogramming of human somatic cell nuclei to generate human induced pluripotent stem (iPS) cells.

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Julian, Katie, Nick Yuhasz, Ethan Hollingsworth e Jaime Imitola. "The “Growing” Reality of the Neurological Complications of Global “Stem Cell Tourism”". Seminars in Neurology 38, n. 02 (aprile 2018): 176–81. http://dx.doi.org/10.1055/s-0038-1649338.

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Abstract“Stem cell tourism” is defined as the unethical practice of offering unproven cellular preparations to patients suffering from various medical conditions. This phenomenon is rising in the field of neurology as patients are requesting information and opportunities for treatment with stem cells for incurable conditions such as multiple sclerosis and amyotrophic lateral sclerosis, despite their clinical research and experimental designation. Here, we review the recent trends in “stem cell tourism” in both the United States and abroad, and discuss the recent reports of neurological complications from these activities. Finally, we frame critical questions for the field of neurology regarding training in the ethical, legal, and societal issues of the global “stem cell tourism,” as well as suggest strategies to alleviate this problem. Although there are ongoing legitimate clinical trials with stem cells for neurological diseases, procedures offered by “stem cell clinics” cannot be defined as clinical research. They lack the experimental and state-of-the-art framework defined by peers and the FDA that focus on human research that safeguard the protection of human subjects against economical exploitation, unwanted side effects, and futility of unproven procedures. “Stem cell tourism” ultimately exploits therapeutic hope of patients and families with incurable neurological diseases and can put in danger the legitimacy of stem cell research as a whole. We posit that an improvement in education, regulation, legislation, and involvement of authorities in global health in neurology and neurosurgery is required.

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Tejaswini, A., N. L. Prasanthi e K. Venkateswara Raju. "A Comparative study of Regulations of Cell and Gene therapy in US, EU and India". International Journal of Drug Regulatory Affairs 10, n. 4 (15 dicembre 2022): 88–95. http://dx.doi.org/10.22270/ijdra.v10i4.569.

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Cell and Gene therapy products were a field that is growing fast inventive therapies. The United States (US) and the European Union (EU) are encouraging their evolution and India is in its nascent stage. For three regions, CGTs fall beneath the biological merchandise regulatory framework of it requires the legal foundation for their evolution. In the EU, there is a defined trend between cell- and gene-based products concerning their classification as advanced therapies or coverage by the legal frameworks, while in the United States there is a wide classification as to classified as organic products. In EU, USA and India, to allocate a cell or an gene product’s as innovative therapy, care has to be taken for therapy of cells involves manoeuvres that amend their characters which are organic, as the term tactic in the USA is difference between systemic and non- systemic cells and gene therapy products. A descriptive analysis was carried out. Till now in USA 20 CGTPs are approved, out of 20 GTMP consists of 7 and CTMP consists of 13 products. Many products are under clinical trials, I searched clinical trials website to know the status of clinical trials in USA. I found 355 clinical trials under ATMPs, out of 355 GTMP consist of 225, SCTMP consists of 105, and CATMP consists of 25. In India the procedures are of two types which are to speed up the drug approval process for the betterment of everyone. They are 1) Conditional Approval, 2). Fast Track Approval. There are only 4 products were approved namely Apceden, Stempeucel, Ossgrow and Cartigrow. The problems related to clinical has been degenerate as the unproven stem cell clinics numbers in the USA reportedly were increased to approximately 715 by 2017. Therefore, the unproven industry of sanatorium is a moving intention essential in method examine and regulatory lapse.

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Pizon, Monika, Dorothea Schott, Ulrich A. Pachmann, Katharina Pachmann e Rainer Schobert. "Chick chorioallantoic membrane (CAM) assays as a model of xenografts derived from circulating cancer stem cells from breast cancer patients." Journal of Clinical Oncology 38, n. 15_suppl (20 maggio 2020): e15596-e15596. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e15596.

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e15596 Background: Circulating cancer stem cells (cCSCs) are a rare fraction of circulating tumor cells with a profile of stemness, resistance to chemotherapy and the capacity to generate metastases. Patient-derived xenografts (PDX) are an increasingly noticed tool in oncology, providing biologically meaningful models of many cancer types, and potential platforms for the development of precision oncology approaches. Commonly, mouse models are used for the in vivo assessment of potential new therapeutic targets in cancers. However, given the high cost, time investment, and legal obligations of such animal models CAM assays are an attractive alternative. Methods: In this study, primary cultures from circulating cancer stem cells were established using sphere-forming assays. Subsequently, tumorspheres were transplanted onto the CAM membrane of fertilized chicken eggs to form secondary microtumors. Results: We have developed an innovative in vitro platform for cultivation of CSCs from peripheral blood of breast cancer patients. The number of tumorspheres increased significantly with tumor progression. Patients with metastatic disease had statistically more tumorspheres as compared to patients without metastasis (30 vs 10/100µl blood, p < 0.05). Patients with multiple metastases had more tumorspheres compared to patients with single metastases (30 vs 60/100µl blood, p < 0.05). The number of tumorspheres was positively correlated with Ki-67, Her2 status and grade score in primary breast tumors. Tumorspheres showed self-renewal, growth potentials, invasion and differentiation in vivo. Their transplantation on CAM membranes resulted in the rapid formation of microtumors in many cases. These tumors pathologically closely resembled the primary tumor. The success rate of PDX was positively correlated with aggressiveness and proliferation capacity of the primary tumor. Conclusions: The number of tumorspheres cultured from peripheral blood of cancer patients and the success rate of establishing PDX directly reflect the aggressiveness and proliferation capacity of the primary tumor. A CAM-based PDX model using circulating cancer stem cells provides a fast, low-cost, easy to handle and powerful preclinical platform for drug screening, therapy optimization, and biomarker discovery.

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Pyatigorskaya, N. V., M. A. Tulina, Zh I. Aladysheva e V. V. Beregovykh. "INTERNATIONAL APPROACHES TO THE REGULATION OF CELL THERAPY PRODUCTS". Annals of the Russian academy of medical sciences 68, n. 8 (19 agosto 2013): 4–8. http://dx.doi.org/10.15690/vramn.v68i8.715.

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This article is a review of the main methods and approaches used in regulation of cell therapy products in the United States of America, Canada, European Union, Australia, Japan and South Korea. Intensive developments of scientific and technological aspects in stem cell and tissue engineering have led to the wide use of human cells and tissues for the treatment of various diseases and injuries of organs and tissues. Drug regulatory agencies of different countries are working on implementation of a risk-based legal framework with some common features. In many countries there is a multilevel control system that assures quality and safety of used cell products. Competent authorities establish strict requirements both to safety of the products and to the implemented standards of good laboratory, manufacturing, clinical and tissue practices.

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Montanari Vergallo, Gianluca. "Freedom of Scientific Research and Embryo Protection Under Italian and European Court of Human Rights’ Jurisprudence. Brief European Legislation Overview". European Journal of Health Law 28, n. 1 (25 gennaio 2021): 3–25. http://dx.doi.org/10.1163/15718093-bja10036.

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Abstract The paper addresses the issues of admissibility of human embryo research and the legal protection to be recognized, in light of the growing importance that scientific research has been gaining in the clinical and biomedical fields of embryonic stem cells for therapeutic purposes. As for human embryo experimentation, particularly on cryopreserved supernumerary embryos, European legislation varies, since the European Court has granted member States a wide margin of appreciation. Some countries, including Italy, have strict legislation protecting embryos from the fertilisation stage, whereas others have taken permissive approaches, allowing experimentation until 14 days after fertilisation. Science, however, has shown that the 14-day limit can be moved. The author finds it necessary to achieve broad international consensus and shared regulations. Lawmakers, however, need to balance respect for the principle of life, represented by the embryo, against scientific needs, in order to devise sound regulations safeguarding both apparently conflicting fundamental values.

24

Lewicki, Zbigniew. "WYBRANE ZAGADNIENIA RELACJI RELIGIA-KOŚCIÓŁ-PAŃSTWO-PRAWO W STANACH ZJEDNOCZONYCH". Zeszyty Prawnicze 14, n. 1 (8 dicembre 2016): 55. http://dx.doi.org/10.21697/zp.2014.14.1.02.

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SELECTED ASPECTS OF THE INTERRELATIONSHIP BETWEEN CHURCH, STATE, RELIGION, AND THE LAW IN THE UNITED STATESSummaryThe United States is a secular state which at the same time puts religion and its institutions at the centre of its legal and constitutional considerations. This situation leads to frequent tension between state institutions and the followers of different religions, whose religious requirements or prohibitions come into conflict with the uniform legal standards. The classic examples of this include Mormon polygamy, which Mormons consider a condition of salvation, but which has been found unconstitutional; and the use of legally prohibited drugs by the followers of Indian religions during their religious ceremonies. Recognition of the needs of worshippers in the latter case shows that over time the U.S. authorities have tended more and more to acknowledge the need to take into account the specific requirements of the non-mainstream religious institutions. Another specific feature of the U.S. system of constitutional law is that as a rule such discrepancies are settled not by Congress but by the Supreme Court, although the two institutions have been known to make conflicting decisions on the same issue. The article is also a review of judicial decisions and legislative acts on controversial issues like abortion, the admissibility of the use of stem cells, same-sex marriages, and conscientious objection to military service.

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Mollaki, Vasiliki. "Ethical Challenges in Organoid Use". BioTech 10, n. 3 (28 giugno 2021): 12. http://dx.doi.org/10.3390/biotech10030012.

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Abstract (sommario):

Organoids hold great promises for numerous applications in biomedicine and biotechnology. Despite its potential in science, organoid technology poses complex ethical challenges that may hinder any future benefits for patients and society. This study aims to analyze the multifaceted ethical issues raised by organoids and recommend measures that must be taken at various levels to ensure the ethical use and application of this technology. Organoid technology raises several serious ethics issues related to the source of stem cells for organoid creation, informed consent and privacy of cell donors, the moral and legal status of organoids, the potential acquisition of human “characteristics or qualities”, use of gene editing, creation of chimeras, organoid transplantation, commercialization and patentability, issues of equity in the resulting treatments, potential misuse and dual use issues and long-term storage in biobanks. Existing guidelines and regulatory frameworks that are applicable to organoids are also discussed. It is concluded that despite the serious ethical challenges posed by organoid use and biobanking, we have a moral obligation to support organoid research and ensure that we do not lose any of the potential benefits that organoids offer. In this direction, a four-step approach is recommended, which includes existing regulations and guidelines, special regulatory provisions that may be needed, public engagement and continuous monitoring of the rapid advancements in the field. This approach may help maximize the biomedical and social benefits of organoid technology and contribute to future governance models in organoid technology.

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Blikhar, M. M., I. M. Zharovska, N. V. Ortynska, I. I. Komarnytska e R. M. Matkivska. "Bioethics in a transformation society on the example of the legal regulation". REPRODUCTIVE ENDOCRINOLOGY, n. 67 (31 marzo 2023): 115–20. http://dx.doi.org/10.18370/2309-4117.2023.67.115-120.

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The article is devoted to bioethical problems that exist in a transformational society. The most important issues are considered, including organ and tissue transplantation, use of embryonic and stem cells for the treatment, gene therapy, in vitro fertilization, cloning, etc. It is emphasized that along with scientific progress there are deep transformations connected with this process in the socio-psychological and cultural spheres, the reason for which is the penetration into mass culture and the mentality of new ideas, conceptions and terms. Emphasis was placed on the need to create a DNA database of servicemen, which is especially relevant during the wartime in Ukraine. Attention is drawn to the need to create special legislation for quality legal regulation of surrogacy, which is especially relevant today. The problems of biomedical transformations and their conflict became the subject of consideration by scientists. Recent studies are devoted to a number of issues related to updating the understanding of the determinants of bioethics in various directions. First of all, attention should be paid to the genesis of the basic standards of bioethics. T. Beauchamp and J. Childress in many editions and reprints have transformed the understanding of the problem over forty years, and it is now agreed that it should be considered within four broad moral principles: respect for autonomy, benevolence, and justice. They can and should be seen as arising historically and philosophically from general morality, as universal morality (as opposed to pure relativism or pluralism) gradually became an integral part of the principled approach. Taking into account all the latest trends in the field of biomedicine, the purpose of this article is to address the problem of the development of biomedical legal standards in Ukraine and the issues of combining them with national identity in the current conditions of the pandemic crisis. The relevance of this topic is important for several reasons: it can serve as a basis for a comparative analysis of the practical application of biomedical legal standards; the example of Ukraine is valuable as an experimental benchmark of the legal policy of the states of the former USSR for the analysis of the development of the post-Soviet socio-legal and cultural sphere; will make it possible to interpret identity in the context of globalized changes.

27

Hall, Stephen S. "Stem Cells: A Status Report". Hastings Center Report 36, n. 1 (2006): 16–22. http://dx.doi.org/10.1353/hcr.2006.0009.

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Dhamodaran, Kamesh, Murali Subramani, Murugeswari Ponnalagu, Reshma Shetty e Debashish Das. "Ocular stem cells: a status update!" Stem Cell Research & Therapy 5, n. 2 (2014): 56. http://dx.doi.org/10.1186/scrt445.

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Zwaka, Thomas P. "Status Anxiety among Pluripotent Stem Cells?" Developmental Cell 42, n. 6 (settembre 2017): 555–56. http://dx.doi.org/10.1016/j.devcel.2017.09.006.

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SAGAN, AGATA, e PETER SINGER. "THE MORAL STATUS OF STEM CELLS". Metaphilosophy 38, n. 2-3 (aprile 2007): 264–84. http://dx.doi.org/10.1111/j.1467-9973.2007.00482.x.

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Martinho, Andreia Martins, e Leigh Turner. "Stem cells in court: historical trends in US legal cases related to stem cells". Regenerative Medicine 12, n. 4 (aprile 2017): 419–30. http://dx.doi.org/10.2217/rme-2017-0002.

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Lebacqz, Karen, Carol Tauer, Glenn McGee e Arthur Caplan. "Stem Cells". Hastings Center Report 29, n. 4 (luglio 1999): 4. http://dx.doi.org/10.2307/3528057.

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Reddy, Kaladhar B. "Stem Cells: Current Status and Therapeutic Implications". Genes 11, n. 11 (20 novembre 2020): 1372. http://dx.doi.org/10.3390/genes11111372.

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Abstract (sommario):

Cancer stem cells (CSCs) are a class of pluripotent cells that have been observed in most types of cancers. Evolving evidence suggests that CSCs, has the ability to self-renew and initiate tumors, may be responsible for promoting therapeutic resistance, tumor recurrence and metastasis. Tumor heterogeneity is originating from CSCs and its progenitors are recognized as major difficulty in efficaciously treating cancer patients. Therefore, understanding the biological mechanisms by which CSCs survive chemo- and-radiation therapy has the potential to identify new therapeutic strategies in the future. In this review, we summarized recent advances in CSC biology and their environment, and discuss about the potential therapies to prevent therapeutic resistance.

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Rugg-Gunn, Peter J., Anne C. Ferguson-Smith e Roger A. Pedersen. "Epigenetic status of human embryonic stem cells". Nature Genetics 37, n. 6 (1 maggio 2005): 585–87. http://dx.doi.org/10.1038/ng1556.

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Mackey, M. C. "Cell kinetic status of haematopoietic stem cells". Cell Proliferation 34, n. 2 (aprile 2001): 71–83. http://dx.doi.org/10.1046/j.1365-2184.2001.00195.x.

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36

Alberio, Ramiro, Keith H. Campbell e Andrew D. Johnson. "Reprogramming somatic cells into stem cells". Reproduction 132, n. 5 (novembre 2006): 709–20. http://dx.doi.org/10.1530/rep.1.01077.

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Abstract (sommario):

Recent scientific achievements in cell and developmental biology have provided unprecedented opportunities for advances in biomedical research. The demonstration that fully differentiated cells can reverse their gene expression profile to that of a pluripotent cell, and the successful derivation and culture of human embryonic stem cells (ESCs) have fuelled hopes for applications in regenerative medicine. These advances have been put to public scrutiny raising legal, moral and ethical issues which have resulted in different levels of acceptance. Ethical issues concerning the use of cloned human embryos for the derivation of stem cells have stimulated the search for alternative methods for reversing differentiated cells into multi/pluripotent cells. In this article, we will review the present state of these reprogramming technologies and discuss their relative success. We also overview reprogramming events after somatic cell nuclear transfer (SCNT), as they may further instructex ovostrategies for cellular manipulation.

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Kalwak, Krzysztof, Peter Bader, Jean-Hugues Dalle, Petr Sedlacek, Jochen Buechner, Marianne Ifversen, Peter Svec et al. "Comparable Outcome after Busulfan- or Treosulfan-Based Conditioning Regimen in Children Above 4 Years of Age with ALL Undergoing Allogeneic HSCT. Results from the Prospective International Forum-Trial". Blood 142, Supplement 1 (28 novembre 2023): 232. http://dx.doi.org/10.1182/blood-2023-180728.

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Purpose: Total body irradiation (TBI) has proved to be the “gold standard” as part of the conditioning regimen before allogeneic hematopoietic stem cell transplantation (HSCT) in pediatric patients with acute lymphoblastic leukemia (ALL). Its superiority over chemo-based conditioning was recently demonstrated in the prospective, international, randomized phase III study, which enrolled 417 patients beyond the age of 4 years transplanted for ALL in complete morphological remission (CR) from either matched sibling (MSD) or matched unrelated donor (MD) (Peters et al, JCO 2021, FORUM study; EudraCT: 2012-003032-22;ClinicalTrials.gov: NCT01949129). The use of either of the two protocol-prespecified chemo-conditioning regimens resulted in significantly worse EFS. Given the unavailability of TBI in some regions/centres and contraindications to TBI in individual patients, we here compare the outcomes of patients who received busulfan (BU) - based regimen vs of those who were given a treosulfan (TREO) - based conditioning in FORUM centres in both randomizing and non-randomizing countries in the years 2013-2018. Patients and methods: Patients ≤ 18 years at diagnosis (median age at HSCT 9.9 years, range 4-19.5), in CR pre-HSCT and with an MSD or MUD were assigned to myeloablative conditioning with fludarabine (FLU), thiotepa (THIO) and either BU or TREO according to country preference. Children transplanted from MSDs received cyclosporine A only as graft-versus-host disease (GvHD) prophylaxis, whereas recipients of MUD HSCT also received short-term methotrexate and anti-thymocyte globulin (ATG). Further details of the transplant procedure have been previously described (Peters C, et al. J Clin Oncol 2021). Results:In addition to the 193 patients from the randomizing countries, the FORUM trial included 115 additional children enrolled in countries where randomization could not occur (for legal or technical reasons). Overall, 180 vs. 128 patients received BU/THIO/FLU vs TREO/THIO/FLU, respectively. There were no differences about the patients' gender, age, and remission status and slight differences regarding donor, stem cell source and MRD status pre-transplant between the two cohorts of patients (see Table 1 for details). Patient's outcomes were updated as of February 20 th, 2023, and median follow-up was 4.2 years (range 0.3 - 9.1). There were neither differences between the 3-year overall survival (OS) (0.71±0.03 for BU/THIO/FLU vs 0.72±0.04 for TREO/THIO/FLU) nor event-free survival (EFS) (0.61±0.04 for BU/THIO/FLU vs 0.55±0.04 for TREO/THIO/FLU, p=NS). Three-year cumulative incidence of relapse (CIR) and non-relapse mortality (NRM) were 0.31±0.03 and 0.08±0.02 following BU/THIO/FLU and 0.36±0.04 and 0.09±0.03 following TREO/THIO/FLU, respectively (p=NS). Only one case of secondary malignancy was observed in the TREO cohort and one case of fatal liver veno-occlusive disease (VOD) in the BU group. No statistical differences were observed regarding the cumulative incidence of both aGvHD and cGvHD between the two groups; 3-year GFRS was almost identical (0.42± 0.04 in the BU/THIO/FLU group and 0.43±0.04 in the TREO/THIO/FLU cohort). There were no differences in OS, EFS, CIR, NRM and GFRS in either CR1 or CR2 patients between the two conditioning regimens. Furthermore, there were no differences in outcomes between countries. Patients given BU/THIO/FLU had a faster leucocyte, neutrophil and platelet recovery as compared to those prepared with TREO/THIO/FLU. Conclusion: Comparable long-term outcomes were observed after BU/THIO/FLU or TREO/THIO/FLU in children with ALL undergoing allogeneic HSCT included in the FORUM trial. Therefore, either of the 2 regimens may be effectively and safely used worldwide in patients > 4 years having a contraindication to or treated in centres/countries unable to deliver TBI.

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Jastaniah, Hanan. "The Legal Principles of Stem Cell Rulings". Jordan Journal of Islamic Studies 19, n. 4 (10 dicembre 2023): 77–107. http://dx.doi.org/10.59759/jjis.v19i4.280.

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This study aims to clarify the reality of stem cells and their uses, as well as to establish rules governing them by extracting rulings on their specific issues within a comprehensive framework that is bound by legal purposes and constrained by legal principles and regulations. This is accomplished by highlighting the recognized principles in regulating legal judgments and providing practical models for stem cell techniques and their legal rulings. Stem cells are undifferentiated cells capable of transforming into any specialized cell type, with the ability to continuously divide and renew. They are expected to be a significant source for treating many chronic diseases. The study concludes that the permissibility of using stem cells and benefiting from them in therapeutic and research fields requires the establishment of a comprehensive system of legal principles. The legal judgment regarding the use of stem cells is based on the permissibility of their source. If the source is permissible, their use is allowed, considering the balance between benefits and harms in accordance with the objectives of Islamic law. Furthermore, it is permissible to store them in specialized banks for both therapeutic and research purposes. Among the legal principles for the permissibility of using permissible stem cells are obtaining consent from the donor or the one with legal authority and ensuring the guarantee in cases related to this issue, arising from deceit, negligence, violation of Shar'ia or regulatory principles.

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Moreno, Jonathan, e Sam Berger. "Taking Stem Cells Seriously". American Journal of Bioethics 6, n. 5 (ottobre 2006): 6–7. http://dx.doi.org/10.1080/15265160600953905.

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Taupitz, Jochen. "Legal Aspects of Research with Human Embryonic Stem Cells". European Review 25, n. 1 (febbraio 2017): 121–30. http://dx.doi.org/10.1017/s1062798716000399.

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Abstract (sommario):

Research with human embryonic stem cells (HESC) is very much disputed from an ethical point of view as it requires the destruction of the embryo to derive the stem cells. The legal situation in Europe is heterogeneous. This article gives an overview of the current debate on this topic by outlining the international regulations and the national legislation in the European Union. It is shown that the different legal positions are like an in vivo experiment for contrasting solutions. Furthermore, the legal situation in Germany is examined in more detail and with it the effectiveness and the constitutionality of the requirements.

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Dolgin, Elie. "Amid legal uncertainties, NIH approves more embryonic stem cells". Nature Medicine 17, n. 1 (gennaio 2011): 5. http://dx.doi.org/10.1038/nm0111-5b.

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Henning, Robert J. "Current status of stem cells in cardiac repair". Future Cardiology 14, n. 2 (marzo 2018): 181–92. http://dx.doi.org/10.2217/fca-2017-0072.

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Sobani, ZainA, SyedA Quadri e AtherS Enam. "Stem cells for spinal cord regeneration: Current status". Surgical Neurology International 1, n. 1 (2010): 93. http://dx.doi.org/10.4103/2152-7806.74240.

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44

Visvader, Jane E., e Geoffrey J. Lindeman. "Cancer Stem Cells: Current Status and Evolving Complexities". Cell Stem Cell 10, n. 6 (giugno 2012): 717–28. http://dx.doi.org/10.1016/j.stem.2012.05.007.

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Stoica, George. "Cancer stem cells: Current status and future directions". Veterinary Journal 205, n. 2 (agosto 2015): 124–25. http://dx.doi.org/10.1016/j.tvjl.2015.02.002.

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Li, He, Yunzhe Tian, Lihui Xie, Xiuxing Liu, Zhaohao Huang e Wenru Su. "Mesenchymal stem cells in allergic diseases: Current status". Allergology International 69, n. 1 (gennaio 2020): 35–45. http://dx.doi.org/10.1016/j.alit.2019.08.001.

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Jones, Elena, e Xuebin Yang. "Mesenchymal stem cells and bone regeneration: Current status". Injury 42, n. 6 (giugno 2011): 562–68. http://dx.doi.org/10.1016/j.injury.2011.03.030.

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Perales-Clemente, Ester, Clifford D. L. Folmes e Andre Terzic. "Metabolic Regulation of Redox Status in Stem Cells". Antioxidants & Redox Signaling 21, n. 11 (10 ottobre 2014): 1648–59. http://dx.doi.org/10.1089/ars.2014.6000.

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Wątorek, Ewa, e Marian Klinger. "Stem cells in nephrology: present status and future". Archivum Immunologiae et Therapiae Experimentalis 54, n. 1 (febbraio 2006): 45–50. http://dx.doi.org/10.1007/s00005-006-0004-4.

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Chen, Lanxin, Bo Tang, Guanghong Xie, Rui Yang, Boyang Zhang, Yueqi Wang, Yan Zhang, Daozhen Jiang e Xueming Zhang. "Bovine Pluripotent Stem Cells: Current Status and Prospects". International Journal of Molecular Sciences 25, n. 4 (9 febbraio 2024): 2120. http://dx.doi.org/10.3390/ijms25042120.

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Abstract (sommario):

Pluripotent stem cells (PSCs) can differentiate into three germ layers and diverse autologous cell lines. Since cattle are the most commonly used large domesticated animals, an important food source, and bioreactors, great efforts have been made to establish bovine PSCs (bPSCs). bPSCs have great potential in bovine breeding and reproduction, modeling in vitro differentiation, imitating cancer development, and modeling diseases. Currently, bPSCs mainly include bovine embryonic stem cells (bESCs), bovine induced pluripotent stem cells (biPSCs), and bovine expanded potential stem cells (bEPSCs). Establishing stable bPSCs in vitro is a critical scientific challenge, and researchers have made numerous efforts to this end. In this review, the category of PSC pluripotency; the establishment of bESCs, biPSCs, and bEPSCs and its challenges; and the application outlook of bPSCs are discussed, aiming to provide references for future research.