Ghosn, Mariam; Ford, Norman The adult stem cells are capable of self-renewal and are responsible for replenishing cells throughout an individual's lifetime, residing not only at embryonic stage but also in children and adults. The latest advancements and updates in adult stem cell technology demonstrate that it might be possible to generate stem cells for therapeutic uses without the creation or destruction of human embryos.

Stem cell technology is an emerging science field; it is the unique regenerative ability of the pluripotent stem cell which scientists hope would be effective in treating various medical conditions. While it has gained significant advances in research, it is a sensitive subject involving human embryo destruction and human experimentation, which compel governments worldwide to ensure that the related procedures and experiments are conducted ethically. Based on face-to-face interviews with selected Malaysian ethicists, scientists and policymakers, (...) the objectives and effectiveness of the current Guideline for Stem Cell Research and Therapy are examined. The study’s findings show that the guideline is rather ineffective in ensuring good ethical governance of the technology. A greater extent of unethical conduct is likely present in the private medical clinics or laboratories offering stem cell therapies compared with the public medical institutions providing similar services, as the latter are closely monitored by the governmental agencies enforcing the relevant policies and laws. To address concerns over malpractices or unethical conduct, this paper recommends a comprehensive revision of the current stem cell guideline so that adequate provisions exist to regulate the explicit practices of the private and public stem cell sectors, including false advertising and accountability. The newly revised Malaysian stem cell guideline will align with the Guidelines for Stem Cell Research and Clinical Translation of the International Society for Stem Cell Research containing secular but universal moral rules. However, a regulatory policy formulated to govern the technology remains the main thrust of empowering the guideline for compliance among the stakeholders. (shrink)

This book takes as its point of departure a humble cell lying on the intersection of ideas as diverse and yet interlaced as life, knowledge, commerce, governance, and ethics. It seeks to deepen the understanding of stem cell entities and the concerns, hopes, and aspirations that shape and make them viable therapeutic entities in the context of rapid globalization. Several key intersections between individual, group, and institutional relationships have become central to locating and debating the production of (...) stem cells today. This edited collection addresses three overarching concerns: regenerating the notion of ethics, the emerging therapeutic horizons, and the position of the patient. As a whole this book seeks to explain how stem cells are accommodated, contested, and used in contemporary India and around the globe through an informed unpacking of issues underpinning contestation and promotion bestriding these technological developments. The authors offer a truly multi-disciplinary perspective, stimulating conversation between the social sciences, biological sciences and the patient. The concerns expressed and highlighted by these conversations are embedded in a vast geo-political expanse stretching from India to Euro-America and will be of great interest to academics and practitioners across fields including science technology studies, medicine and international development. (shrink)

Robert Sparrow has recently raised the possibility that stem cell technology could in the future be used to create multiple generations of embryos in the laboratory before transferring one embryo to a woman’s womb to create a pregnancy. Sparrow argues that any children produced in this way would be genetic orphans—they would lack living genetic parents—and explores the possible moral implications of this. A number of other authors have raised objections to Sparrow’s moral claims, but his descriptive (...) claim remains unchallenged. In this chapter, we challenge it, arguing that Sparrow’s imagined technology could be performed in such a way that the children produced would have living genetic parents. (shrink)

Biological pacemakers can be achieved by various gene‐based and cell‐based approaches. Embryonic stem cells (ESCs)‐derived pacemaker cells might be the most promising way to form biological pacemakers, but there are challenges as to how to control the differentiation of ESCs and to overcome the neoplasia, proarrhythmia, or immunogenicity resulting from the use of ESCs. As a potential approach to solve these difficult problems, tissue‐engineering techniques may provide a precise control on the different cell components of multicellular aggregates (...) and the forming of a construct with‐defined architectures and functional properties. The combined interactions between ESC‐derived pacemaker cells, supporting cells, and matrices may completely reproduce pacemaker properties and result in a steady functional unit to induce rhythmic electrical and contractile activities. As ESCs have a high capability for self‐renewal, proliferation, and potential differentiation, we hypothesize that ESCs can be used as a source of pacemaker cells for tissue‐engineering applications and the ambitious goal of biological cardiac pacemakers may ultimately be achieved with ESCs via tissue‐engineering technology. (shrink)

Biological pacemakers can be achieved by various gene‐based and cell‐based approaches. Embryonic stem cells (ESCs)‐derived pacemaker cells might be the most promising way to form biological pacemakers, but there are challenges as to how to control the differentiation of ESCs and to overcome the neoplasia, proarrhythmia, or immunogenicity resulting from the use of ESCs. As a potential approach to solve these difficult problems, tissue‐engineering techniques may provide a precise control on the different cell components of multicellular aggregates (...) and the forming of a construct with‐defined architectures and functional properties. The combined interactions between ESC‐derived pacemaker cells, supporting cells, and matrices may completely reproduce pacemaker properties and result in a steady functional unit to induce rhythmic electrical and contractile activities. As ESCs have a high capability for self‐renewal, proliferation, and potential differentiation, we hypothesize that ESCs can be used as a source of pacemaker cells for tissue‐engineering applications and the ambitious goal of biological cardiac pacemakers may ultimately be achieved with ESCs via tissue‐engineering technology. -/- . (shrink)

Recent advances in stem cell research suggest that in the future it may be possible to create eggs and sperm from human stem cells through a process that we term in vitro gametogenesis (IVG). IVG would allow treatment of some currently untreatable forms of infertility. It may also allow same-sex couples to have genetically-related children. For example, cells taken from one man could potentially be used to create an egg, which could then be fertilised using naturally produced (...) sperm from another man to create a genetically-related child with half of its DNA from each of the men. In this chapter, we consider whether this technology could justifiably be denied to same-sex couples if it were made available as a fertility treatment to different-sex couples. We argue that it could not. (shrink)

This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reflect on early stages of the research as the field debated the issues of consent, (...) moral status, use of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate. (shrink)

Controversy often follows when patents are obtained in a pioneering area of technology. Patent filing activity in the field of regenerative medicine and in relation to stem cells in particular has not escaped opprobrium, although it is instructive to compare the nature of the debates that are taking place over the patenting of stem cells in the US and Europe. In the US, debate over the early patent applications made by the Wisconsin Alumni Research Foundation has been (...) intense2, but at least it appears to have been grounded firmly in patent law principles. In Europe, the debate has skewed away from the basic patent law tenets of novelty, inventiveness and industrial utility and has entered something of a twilight zone, with the European Patent Office serving as a diffident forum for difficult moral and ethical arguments about the destruction of human embryos and the commercial exploitation of human life. (shrink)

This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reflect on early stages of the research (members of the IRBs, the Geron Ethicist Advisory (...) Board, and the National Bioethics Advisory Commission) as the field debated the issues of consent, moral status, use of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate. (shrink)

The recent success in generating live offspring from embryonic stem cell –derived gametes in mice sparked visions of growing tailor-made sperm for men faced with infertility. However, although this development will almost certainly lead to new insights into the processes underlying spermatogenesis and thus in the possible causes of male infertility, it is less certain if deriving sperm from ES cells, which are in turn derived from a sterile man, can make someone a genetic parent. As the gap (...) between newly envisioned reproductive technologies and natural reproduction widens, the question thus needs to be asked if these possible therapies still lead to genetic parenthood. (shrink)

Robust ex vivo expansion of umbilical cord blood (UCB) derived hematopoietic stem and progenitor cells (HSPCs) should enable the widespread use of UCB as a source of cells to treat hematologic and immune diseases. Novel approaches for HSPC expansion have recently been developed, setting the stage for the production of blood stem cell derived products that fulfill our current best known criteria of clinical relevance. Translating these technologies into clinical use requires bioengineering strategies to overcome challenges of (...) scale‐up, reproducibility, and product quality assurance. Clinical‐scale implementation should also define criteria and targets for cost‐effective cell manufacturing. As production strategies become more effective, new opportunities in the therapeutic use of ex vivo expanded hematopoietic cell products will emerge. Herein we examine key technological milestones that need to be met in order to move ex vivo expanded HSPC therapies from the bench‐top to the bedside in a robust and reliable manner. (shrink)

Robust ex vivo expansion of umbilical cord blood (UCB) derived hematopoietic stem and progenitor cells (HSPCs) should enable the widespread use of UCB as a source of cells to treat hematologic and immune diseases. Novel approaches for HSPC expansion have recently been developed, setting the stage for the production of blood stem cell derived products that fulfill our current best known criteria of clinical relevance. Translating these technologies into clinical use requires bioengineering strategies to overcome challenges of (...) scale‐up, reproducibility, and product quality assurance. Clinical‐scale implementation should also define criteria and targets for cost‐effective cell manufacturing. As production strategies become more effective, new opportunities in the therapeutic use of ex vivo expanded hematopoietic cell products will emerge. Herein we examine key technological milestones that need to be met in order to move ex vivo expanded HSPC therapies from the bench‐top to the bedside in a robust and reliable manner. (shrink)

The closely related debates concerning abortion, the protection of the embryo and stem cell science have captured the legislative agenda in Mexico in recent years. This paper examines some contemporary debates related to stem cell science and the legal and political action that has followed in the wake of the latest Supreme Court judgment on abortion, which debates are directly linked to the degrees of protection of the embryo stipulated in the Mexican Constitution. While some Mexican (...) states have opted to take no further action, others, where conservative political forces are in the majority, have been very active in seeking to ensure that their constitutions are amended to protect human life from conception onwards. This intense legislative activity has not, however, been repeated at the federal level, where there is currently no overarching national regulatory framework governing stem cell research. Although major efforts have been made by the conservative block within the Senate to bring forward legislative proposals for the prohibition of human embryonic stem cell research, and despite the public expression by the federal government of its commitment to encourage inward investment and innovation in the area of biotechnology, stem cell science has, so far, remained unregulated. The legislative challenge is to resist the pressure that has been injected by religious leaders and to act in accordance with the values and principles adopted by the community in the Mexican Constitution. In the final analysis, Mexico faces particular difficulties in accommodating conservative political forces on one hand, while recognising on the other its need, as an emerging economy, to promote a progressive approach to innovation in biotechnology. (shrink)

On 25 April 2002, the German Parliament has passed a strict new law referring to stem cell research. This law took effect on July 1, 2002. The so-called embryonic Stem Cell Act ( Stammzellgesetz — StZG ) permits the import of embryonic stem (ES) cells isolated from surplus IvF-embryos for research reasons. The production itself of ES cells from human blastocysts has been prohibited by the German Embryo Protection Act of 1990, with the exception of (...) the use of ES cells which exist already. The debate on the legitimate use of ES cells escalated, after the main German research funding agency, the Deutsche Forschungsgemeinschaft (DFG), unexpectedly published new guidelines recommending are stricted use of human ES cells for research. Meanwhile, the debate has ethically dividedsociety, political parties, government and church members into a group supporting and a group rejecting ES cell research. The arguments in favour of such a research can be summarized as arguments derived from a new ethics ofhealing calling for a therapeutic imperative, whereas the arguments against can be summarized as arguments violating the fundamental principle of human dignity as they imply the destruction of human embryos. This article willtry to present and evaluate various ethical arguments founded on the latest biological and medical data on the potential use of stem cell technologies. It will finally come to the conclusion that ES cell research is opposed to human dignity, since the procedures of isolating ES cells require the destruction and instrumentalization of human embryos. Human embryos are human beings at a very early stage of their development, fully possessing the ability of completing their development. At this very early stage, human embryos are extremely dependent and fragile, and thus vulnerable corporealities. Vulnerability and human dignity demand the protection of the embryo's corporeal integrity. Hence, this essay will try to propagate research with adult stem(AS) cells, a procedure which does not require the destruction of human embryos; with regard to the necessary plasticity, it should be emphasized that AS cells very much resemble ES cells. (shrink)

Given their heterogeneity and lack of defining markers, it is surprising that multipotent mesenchymal stem/stromal cells (MSCs) have attracted so much translational attention, especially as increasing evidence points to their predominant effect being not by donor differentiation but via paracrine mediators and exosomes. Achieving long-term MSC donor chimerism for treatment of chronic disease remains a challenge, requiring enhanced MSC homing/engraftment properties and manipulation of niches to direct MSC behaviour. Meanwhile advances in nanoparticle technology are furthering the development of (...) MSCs as vehicles for targeted drug delivery. For treatment of acute injuries, systemic cell-free exosome delivery may ultimately displace current emphasis on empiric donor-cell transplantation for anti-inflammatory, immunomodulatory and repair-promoting effects. Exploration of potential clinical sources of MSCs has led to increased utilisation of perinatal MSCs in allogeneic clinical trials, reflecting their ease of collection and developmentally advantageous properties. (shrink)

This paper queries why we are more reluctant to perform stem cell research on human than on nonhuman embryos, given their remarkable similarities together with the former's greater promise for addressing human illnesses. I begin by examining two leading arguments for prohibiting stem cell research on human embryos. The first type of argument suggests that we should not interfere with the potential for human life. This argument, advanced in different ways by both utilitarians and religious believers, (...) inadequately grapples with the moral complexities raised by current technologies, such as IVF and cloning. Moreover, it fails to address the significant adverse effects of human overpopulation to both human and nonhuman well-being. The second line of argument addressed here suggests that we are morally prohibited from "playing God." This argument overlooks the various ways in which we do—indeed, we must—make life and death decisions. Further, the argument rests on an undefended assumption that we are only prohibited from making such decisions with regard to human life, while remaining free to make such decisions with regard to animals without apparent moral qualms. On the contrary, I argue that, from a fully ethical Darwinian standpoint, we must treat both human and nonhuman life with respect. Far from requiring us to abstain from difficult moral decision making, an attitude of respect toward all life requires human willingness to take responsibility for making difficult—indeed, sometimes excruciating—moral decisions. (shrink)

The collection and storage of human tissue samples has been present in medicine for centuries, however, biobanking has recently become a dedicated activity. The technological developments that have allowed the isolation, storage and long term viability of human cells ex vivo, and to obtain relevant scientific information, including genetic information, open tremendous possibilities for advancing biomedical research. At the same time, these possibilities have raised complex ethical issues regarding tissue donors, researchers using samples and society awareness of biobanking as a (...) whole. This article aims to review the operation of stem cell biobanks, related ethical issues and the legal framework in Spain. Special consideration will be given to the new but revolutionary appearance of induced pluripotent stem cells. Most of the topics discussed here will be in the framework of banking adult derived stem cells, which do not entail in themselves any significant ethical dilemma. (shrink)

Sarah Franklin’s Biological relatives: IVF, stem cells, and the future of kinship and Charis Thompson’s Good science: the ethical choreography of stem cell research, examine recently normalized biotechnologies. Franklin’s monograph extends her previous work on in vitro fertilization , deconstructing the success of a technology that, she argues, has grown “curiouser and curiouser” while taking hold in scientific and social life. IVF in its diverse aspects becomes a lens for scrutinizing our ambivalence about new technology, (...) which Franklin articulates by putting disparate literatures into conversation: feminist science studies, political economy, fine art, and more. Thompson’s Good science focuses more concretely on the first decade of human pluripotent stem cell research, tracing the field from the innovation of cultured human embryonic stem cells through Bush-era policy debates, to current acceptance of stem cell research as a part of the scientific and policy landscape. Th .. (shrink)

Abstract.Biotechnology deals not only with new types of therapies for preventing and curing diseases but also with the creation of new technologies for the production of human flesh. Its ultimate aim is to create a new human body, a new person. Biotechnology wears the cloak not only of a new scientific paradigm but also of a kind of messianic religion. To develop new therapies, to destroy illnesses, to transform the human body into a nonmortal one—these are some of the promises (...) it makes. In time, many of these promises will undoubtedly prove to be illusory, but they will nevertheless continue to have a significant impact on the way people think. Through a process that I call biotechnotheological analysis I show that biotechnology could eventually become not only a type of secular religion but even a type of mythic para‐Christian religion, one that incorporates the two most significant processes at work in every mythical religion: the process of mimesis and the ritual of the scapegoat. The essay is an attempt to understand biotechnological achievements, especially in stem‐cell research, in this new biotechnotheological way. (shrink)

This paper is based on linked qualitative studies of the donation of human embryos to stem cell research carried out in the United Kingdom, Switzerland, and China. All three studies used semi-structured interview protocols to allow an in-depth examination of donors’ and non-donors’ rationales for their donation decisions, with the aim of gaining information on contextual and other factors that play a role in donor decisions and identifying how these relate to factors that are more usually included in (...) evaluations made by theoretical ethics. Our findings have implications for one factor that has previously been suggested as being of ethical concern: the role of gratitude. Our empirical work shows no evidence that interpersonal gratitude is an important factor, but it does support the existence of a solidarity-based desire to “give something back” to medical research. Thus, we use empirical data to expand and refine the conceptual basis of bioethically theorizing the IVF–stem cell interface. (shrink)

ABSTRACTGiven its intimate relationship with the human body and its environment, biotechnology innovation, and more particularly stem cell research innovations as a part thereof, implicate diverse social and moral/ethical issues. This paper explores some of the most important and controversial moral concerns raised by human embryonic stem cell research , focusing on concerns relating to the wellbeing of the embryo and the wellbeing of society . It then considers how and whether these concerns are dealt with (...) in regulatory instruments in Argentina, a southern developing country, examining in particular whether the values underlying these concerns have been translated into practical and effective rules reflective of the primary moral positions advanced. It concludes that Argentina's current state of stem cell research governance fails to consistently reflect the moral positions that have formed and is inadequate given Argentina's activity in this field. (shrink)

Embryonic stem cell research holds great promise for biomedical research, but involves the destruction of human embryos. Katrien Devolder explores the tension between the view that embryos should never be deliberately harmed, and the view that such research must go forward. She provides an in-depth analysis of major attempts to resolve the problem.

Embryonic stem cells are actively debated in political and public policy arenas. However, the connections between stem cell innovation and overall health care policy are seldom elucidated. As with many controversial aspects of medical care, the stem cell debate bridges to a variety of social conversations beyond abortion. Some issues, such as translational medicine, commercialization, patient and public safety, health care spending, physician practice, and access to insurance and health care services, are core health policy (...) concerns. Other issues, such as economic development, technologic progress, fiscal politics, and tort reform, are only indirectly related to the health care system but are frequently seen through a health care lens. These connections will help determine whether the stem cell debate reaches a resolution, and what that resolution might be. (shrink)

Ethics is a philosophical branch of inquiry that reasons between what is right and wrong. The moral philosophy of Socrates, Aristotle, and Plato from ancient Greek became the basis of most of the western ethics. These days, ethics can be divided based on its inquiries for example, normative, descriptive, metaethics, and applied ethics or based on its theories like utilitarianism, emotivism, and universal ethics. In context with applied ethics that examines issues involving emerging technologies, this study will look into the (...) ethics of Malaysian stem cell technology based on written literature. It was mainly to identify Malaysian literature on stem cell ethics through conventional search since the mainstream international database indicated an obvious shortage. The critical review of this literature will facilitate in the understanding of unique position of Malaysia towards stem cell and its ethics in reference to the limited number. Despite the limitation, this can be a preliminary study urging for more inquiries and exploration to fulfil the multiple perspectives in ethics such as the diversity of Malaysian ethics, the impact of ethics in stem cell regulation in Malaysia, and if western contemporary ethics influences Malaysian ethics particularly involving stem cell technology. (shrink)

Should clinicians ask women to donate or even sell their eggs for stem cell research? Enucleated ova are crucial in somatic cell nuclear transfer technologies, but risky for women’s health. Until comparatively recently, very few commentators debated the ethical issues in egg donation and sale, concentrating on the embryo’s status. The unmasking of Hwang Woo Suk, who used over 2,200 ova in his fraudulent research, has finally brought the question of ova donation and sale into prominence. In (...) this article we offer an international comparison of recent responses to this crucial question and suggest that the levels of risk are too imprecise to enable women to give meaningful informed consent for egg extraction. What we do know of the risks also indicates that they are too high and that potential donors or sellers are not being fully informed of their extent, raising disturbing ethical issues concerning commodification, deception, coercion, and exploitation. (shrink)

We have developed a first generation tool for the unbiased identification and characterization of human pluripotent stem cells, termed PluriTest. This assay utilizes all the information contained on a microarray and abandons the conventional stem cell marker concept. Stem cells are defined by the ability to replenish themselves and to differentiate into more mature cell types. As differentiation potential is a property that cannot be directly proven in the stem cell state, biologists have (...) to rely on correlative measurements in stem cells associated with differentiation potential. Unfortunately, most, if not all, of those markers are only valid within narrow limits of specific experimental systems. Microarray technologies and recently next‐generation sequencing have revolutionized how cellular phenotypes can be characterized on a systems‐wide level. Here we discuss the challenges PluriTest and similar global assays need to address to fulfill their enormous potential for industrial, diagnostic and therapeutic applications. (shrink)

Most opponents of somatic cell nuclear transfer and embryonic stem cell technologies base their arguments on the twin assertions that the embryo is either a human being or a potential human being, and that it is wrong to destroy a human being or potential human being in order to produce stem cell lines. Proponents’ justifications of stem cell research are more varied, but not enough to escape the charge of obsession with the status (...) of the embryo. What unites the two warring sides in ‘the stem cell wars’ is that women are equally invisible to both: ‘the lady vanishes.’ Yet the most legitimate property in the body is that which women possess in their reproductive tissue and the products of their reproductive labour. By drawing on the accepted characterisation in the common law of property as a bundle of rights, and on a Hegelian model of contract as mutual recognition, we can lessen the impact of the tendency to regard women and their ova as merely receptacles and women’s reproductive labour as unimportant. (shrink)

While society debates whether and how to use public funds to support work on human embryonic stem cells, many scientific groups and businesses debate a different question — the extent to which patents that cover such stem cells should be permitted to limit or to tax their research. The Wisconsin Alumni Research Foundation, a non-profit foundation that manages intellectual property generated by researchers at the University of Wisconsin at Madison, owns three patents that have been at the heart (...) of the latter controversy. The story of WARF’s patents and the controversy they have fostered highlights not only continuing tensions between proprietary and nonproprietary approaches to developing science and technology, but also an at least partly reassuring capacity of public and private sectors to deal with those tensions in a way that can render them substantially manageable, and frequently more manageable as a technology matures. (shrink)

Most opponents of somatic cell nuclear transfer and embryonic stem cell technologies base their arguments on the twin assertions that the embryo is either a human being or a potential human being, and that it is wrong to destroy a human being or potential human being in order to produce stem cell lines. Proponents’ justifications of stem cell research are more varied, but not enough to escape the charge of obsession with the status (...) of the embryo. What unites the two warring sides in ‘the stem cell wars’ is that women are equally invisible to both: ‘the lady vanishes.’ Yet the most legitimate property in the body is that which women possess in their reproductive tissue and the products of their reproductive labour. By drawing on the accepted characterisation in the common law of property as a bundle of rights, and on a Hegelian model of contract as mutual recognition, we can lessen the impact of the tendency to regard women and their ova as merely receptacles and women’s reproductive labour as unimportant. (shrink)

While society debates whether and how to use public funds to support work on human embryonic stem cells (hESCs), many scientific groups and businesses debate a different question — the extent to which patents that cover such stem cells should be permitted to limit or to tax their research. The Wisconsin Alumni Research Foundation (WARF), a non-profit foundation that manages intellectual property generated by researchers at the University of Wisconsin at Madison, owns three patents that have been at (...) the heart of the latter controversy The story of WARF's patents and the controversy they have fostered highlights not only continuing tensions between proprietary and nonproprietary approaches to developing science and technology, but also an at least partly reassuring capacity of public and private sectors to deal with those tensions in a way that can render them substantially manageable, and frequently more manageable as a technology matures. More particularly, the cumulative story of WARF's patents features three leitmotifs that suggest how an attentive and engaged public sector might commonly succeed in working with public and private sector actors to achieve workable balances between proprietary rights and more general social interests: (1) right holders' decisions to pursue less than full rights assertion or enforcement; (2) the ability of government and other public sector actors to help bring about such decisions through co-option or pressure; and (3) the frequent availability or development of technological alternatives that limit research bottlenecks. (shrink)

The first stage of the human embryonic stem(ES) cell research debate revolved aroundfundamental questions, such as whether theresearch should be done at all, what types ofresearch may be done, who should do theresearch, and how the research should befunded. Now that some of these questions arebeing answered, we are beginning to see thenext stage of the debate: the battle forproperty rights relating to human ES cells. The reason why property rights will be a keyissue in this debate is (...) simple and easy tounderstand: it costs a great deal of money todo this research, to develop new products, andto implement therapies; and private companies,researchers, and health professionals requirereturns on investments and reimbursements forgoods and services. This paper considersarguments for and against property rightsrelating to ES cells defends the followingpoints: (1) It should be legal to buy and sellES cells and products. (2) It should be legalto patent ES cells, products, and relatedtechnologies. (3) It should not be legal tobuy, sell, or patent human embryos. (4) Patentson ES cells, products, and related technologiesshould not be excessively broad. (5) Patents onES cells, products, and related technologiesshould be granted only when applicants statedefinite, plausible uses for their inventions. (6) There should be a research exemption in EScell patenting to allow academic scientists toconduct research in regenerative medicine. (7)It may be appropriate to take steps to preventcompanies from using patents in ES cells,products, and related technologies only toblock competitors. (8) As the field ofregenerative medicine continues to develop,societies should revisit issues relating toproperty rights on a continuing basis in orderto develop policies and develop regulations tomaximize the social, medical, economic, andscientific benefits of ES cell research andproduct development. (shrink)

: During the nearly 10 years since its introduction, preimplantation genetic diagnosis (PGD) has been used predominantly to avoid giving birth to a child with identified genetic disease. Recently, PGD was used by a couple not only to test IVF-created embryos for genetic disease, but also to test for a nondisease trait related to immune compatibility with a child in the family in need of an hematopoetic stem cell transplant. This article describes the case, raises some ethical and (...) policy issues, highlights gaps in U.S. policy, and finally makes some recommendations for addressing advancing genetic and reproductive technologies. (shrink)

It is now 10 years ago that human embryonic stem cell research appeared as a major topic of societal concern following significant scientific breakthroughs.1 2 During these 10 years it has become obvious that stem cell research is embedded in a narrative characterised by hope and hype and that it has created heated moral and political debate. Although it would be tempting to try to deconstruct the importance attributed to hope in this story or to unmask (...) the different instigators active in promoting hype,3–5 the main aim of this editorial is to briefly review the controversies underlying the debate and propose some possible answers to a set of inter-related questions: What are the main disagreements in the stem cell debate? Is there any hope that we can resolve these main disagreements? Has the debate been a fruitful model for future debates about ethically contentious issues in biomedicine, or has it been characterised more by rhetoric than by argument? What kind of ethical debates are most efficient as models for future debates?The two authors agree with regard to the importance of asking these questions, but they disagree about at least some of the answers. Let us start with the questions about the debate and its use as a model for future debates.WHAT KIND OF ETHICAL DEBATE IS MOST EFFICIENT AS A MODEL FOR FUTURE DEBATES?Could it be the case that ethical debates that are characterised by overselling of the potential of the technology are more efficient as models for future debates about ethically contentious issues in biomedicine than more sober and “neutral” debates? The narratives of stem cell research are full of examples of overselling and underselling, and we will suggest that it is precisely for this reason that there is a lot to learn morally from reviewing the narratives. The two main forms of overselling are therapeutic …. (shrink)

Recent advances in reprogramming technology do not bypass the ethical challenge of embryo sacrifice. Induced pluripotent stem cell (iPS) research has been and almost certainly will continue to be conducted within the context of embryo sacrifice. If human embryos have moral status as human beings, then participation in iPS research renders one morally complicit in their destruction; if human embryos have moral status as mere precursors of human beings, then advocacy of iPS research policy that is inhibited (...) by embryo sacrifice concerns renders one morally complicit in avoidable harms to persons. Steps may be taken to address these complicity concerns, but in the final analysis there is no alternative to achieving clarity with respect to the moral status of the human embryo. (shrink)

Hydra are remarkable because they are immortal. Much of immortality can be ascribed to the asexual mode of reproduction by budding, which requires a tissue consisting of stem cells with continuous self‐renewal capacity. Emerging novel technologies and the availability of genomic resources enable for the first time to analyse these cells in vivo. Stem cell differentiation in Hydra is governed through the coordinated actions of conserved signaling pathways. Studies of stem cells in Hydra, therefore, promise critical (...) insights of general relevance into stem cell biology including cellular senescence, lineage programming and reprogramming, the role of extrinsic signals in fate determination and tissue homeostasis, and the evolutionary origin of these cells. With these new facts as a backdrop, this review traces the history of studying stem cells in Hydra and offers a view of what the future may hold. (shrink)

The natural replacement of damaged cells by stem cells occurs actively and often in adult tissues, especially rapidly dividing cells such as blood cells. An exciting case in Boston, however, posits a kind of natural stem cell therapy provided to a mother by her fetus—long after the fetus is born. Because there is a profound lack of medical intervention, this therapy seems natural enough and is unlikely to be morally suspect. Nevertheless, we feel morally uncertain when we (...) consider giving this type of therapy to patients who would not naturally receive it. Much has been written about the ethics of stem cell research and therapy; this paper will focus on how recent advances in biotechnology and biological understandings of development narrow the debate. Here, the author briefly reviews current stem cell research practices, revisits the natural stem cell therapy case for moral evaluation, and ultimately demonstrates the importance of permissible stem cell research and therapy, even absent an agreement about the definition of when embryonic life begins.Although one promising technology, blighted ovum utilisation, uses fertilised but developmentally bankrupt eggs, it is argued that utilisation of unfertilised eggs to derive totipotent stem cells obviates the moral debate over when life begins. There are two existing technologies that fulfil this criterion: somatic cell nuclear transfer and parthenogenic stem cell derivation. Although these technologies are far from therapeutic, concerns over the morality of embryonic stem cell derivation should not hinder their advancement. (shrink)

An increasingly unbridgeable gap exists between the supply and demand of transplantable organs. Human embryonic stem cell technology could solve the organ shortage problem by restoring diseased or damaged tissue across a range of common conditions. However, such technology faces several largely ignored immunological challenges in delivering cell lines to large populations. We address some of these challenges and argue in favor of encouraging contribution or intentional creation of embryos from which widely immunocompatible stem (...) cell lines could be derived. Further, we argue that current immunological constraints in tissue transplantation demand the creation of a global stem cell bank, which may hold particular promise for minority populations and other sub-groups currently marginalized from organ procurement and allocation systems. Finally, we conclude by offering a number of practical and ethically oriented recommendations for constructing a human embryonic stem cell bank that we hope will help solve the ongoing organ shortage problem. (shrink)

Regulators around the world are coming under pressure from patients, clinicians, and industry groups to streamline the market approval process for highly novel biomedical technologies, including stem cells and regenerative medicine products. The rationale for streamlining this process centers on the perceived failures of regulatory systems to encourage biomedical innovation and provide patients with timely access to potentially beneficial yet experimental therapies. Critics claim that the process of generating scientific evidence in phased clinical trials is too costly, time-consuming, and (...) poorly suited for stem cell–based products that, unlike bio-pharmaceuticals, are intended to engraft into the body for long... (shrink)

Until now, philosophical debate about human embryonic stem cell (hESC) research has largely been limited to its ethical dimensions and implications. Although the importance and urgency of these ethical debates should not be underestimated, the almost undivided attention that mainstream and feminist philosophers have paid to the ethical dimensions of hESC research suggests that the only philosophically interesting questions and concerns about it are by and large ethical in nature. My argument goes some distance to challenge the assumption (...) that ethical considerations alone must be foregrounded in philosophical discussions about hESC research by introducing a critical stance on the epistemological and ontological assumptions that underlie and condition it. A central aim of the paper is to show how Foucault's insights into knowledge-power, taken in combination with Hacking's claims about styles of reasoning, can make these assumptions evident, as well as cast light on their potentially deleterious implications for disabled people. Arguing in this way also enables me to draw out constitutive effects of research on stem cells, that is, to indicate how the discursive practices surrounding research on stem cells, as well as the technology itself, contribute to the constitution of impairment. (shrink)

An increasingly unbridgeable gap exists between the supply and demand of transplantable organs. Human embryonic stem cell technology could solve the organ shortage problem by restoring diseased or damaged tissue across a range of common conditions. However, such technology faces several largely ignored immunological challenges in delivering cell lines to large populations. We address some of these challenges and argue in favor of encouraging contribution or intentional creation of embryos from which widely immunocompatible stem (...) cell lines could be derived. Further, we argue that current immunological constraints in tissue transplantation demand the creation of a global stem cell bank, which may hold particular promise for minority populations and other sub-groups currently marginalized from organ procurement and allocation systems. Finally, we conclude by offering a number of practical and ethically oriented recommendations for constructing a human embryonic stem cell bank that we hope will help solve the ongoing organ shortage problem. (shrink)

Multidisciplinary Perspectives on the Donation of Stem Cells and Reproductive Tissue Content Type Journal Article Category Symposium Pages 15-17 DOI 10.1007/s11673-011-9351-x Authors Catherine Waldby, School of Social and Political Sciences, University of Sydney, Sydney, Australia Ian Kerridge, Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building (K25), University of Sydney, Sydney, NSW 2006, Australia Loane Skene, Faculty of Law and Faculty of Medicine, Dentistry and Health Studies, University of Melbourne, Melbourne, VA, Australia Journal Journal of Bioethical (...) Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal Volume Volume 9 Journal Issue Volume 9, Number 1. (shrink)

Stem cell research is a newly emerging technology that promises a wide variety of benefits for humanity. It has, however, also caused much ethical, legal, and theological debate. While some forms of its application were prohibited in the beginning, they have now started to be used in many countries. This fact obliges us to discuss the regulation of stem cell research at national and international level. It is obvious that in order to make regulations and (...) to draw up legislation at national or international levels it helps to know the perspectives of different cultures and faith traditions. In this article the issue is explored from an Islamic perspective. Firstly, some basic information is given about Islam to explain how laws are drawn up and regulations made in this tradition. Secondly, the principles on which the laws and regulations are based are applied to stem cell research, and finally the permitted and prohibited methods of stem cell research are described. The discussions throughout the paper demonstrate that while some ethicists argue that stem cell research is unethical in the Islamic tradition, tradition permits it as long as such research is aimed at improving human health. (shrink)

The emphasis in human pluripotent stem cell (hPSC) technologies has shifted from cell therapy to in vitro disease modelling and drug screening. This review examines why this shift has occurred, and how current technological limitations might be overcome to fully realise the potential of hPSCs. Details are provided for all disease‐specific human induced pluripotent stem cell lines spanning a dozen dysfunctional organ systems. Phenotype and pharmacology have been examined in only 17 of 63 lines, primarily (...) those that model neurological and cardiac conditions. Drug screening is most advanced in hPSC‐cardiomyocytes. Responses for almost 60 agents include examples of how careful tests in hPSC‐cardiomyocytes have improved on existing in vitro assays, and how these cells have been integrated into high throughput imaging and electrophysiology industrial platforms. Such successes will provide an incentive to overcome bottlenecks in hPSC technology such as improving cell maturity and industrial scalability whilst reducing cost. (shrink)

The scientific challenges and ethical controversies facing human embryonic stem cell (hESC) research continue to command attention. The issues posed by patenting hESC technologies have, however, largely failed to penetrate the discourse, much less result in political action. This paper examines U.S. and European patent systems, illustrating discrepancies in the patentability of hESC technologies and identifying potential negative consequences associated with efforts to make available hESC research tools for basic research purposes while at same time strengthening the position (...) of certain patent-holders' rights. Differences between the U.S. and the European contexts may in part explain why the course of hESC research in those jurisdictions ultimately diverges. Nevertheless, questions about whether and how patenting, related agreements, and licensing practices progress and shape the field of hESC research in both the U.S., Europe, and elsewhere must no longer be marginalised. These questions are fundamentally important in determining what benefits are likely to result from hESC research. Assuring these benefits is the moral issue with which patent systems are most intrinsically concerned, and that governments must begin to directly address rather than assume or ignore. (shrink)

In the US, stem cell research is at a moral impasse—many see this research as ethically mandated due to its potential for ameliorating major diseases, while others see this research as ethically impermissible because it typically involves the destruction of embryos and use of ova from women. Because their creation does not require embryos or ova, induced pluripotent stem cells offer the most promising path for addressing the main ethical objections to stem cell research; however, (...) this technology is still in development. In order for scientists to advance induced pluripotent stem cell research to a point of translational readiness, they must continue to use ova and embryos in the interim. How then are we to ethically move forward with stem cell research? We argue that there is personal integrity and value in adopting a ‘moral compromise’ as a means for moving past the moral impasse in stem cell research. In a moral compromise, each party concedes part of their desired outcome in order to engage in a process that respects the values and desires of all parties equitably. Whereas some contend that moral compromise in stem cell research necessarily involves self-contradiction or loss of personal integrity, we argue that in the US context, stem cell research satisfies many of the key pre-conditions of an effective moral compromise. To illustrate our point, we offer a model solution wherein eggs and embryos are temporarily used until non-egg and non-embryonic sources of pluripotent stem cells are developed to a state of translational readiness. (shrink)