Use Of Human Embryos Research Articles

Human Stem Cell Therapy for the Cure of Type 1 Diabetes Mellitus (T1D): A Hurdle Course between Lights and Shadows

Background: T1D is a severe metabolic disorder due to selective autoimmune pancreatic islet β-cell killing, which results in complete abrogation of endogenous insulin secretion. The affected patients, once the disease is clinically overt, must immediately undertake insulin supplementation according to intensive therapy regimens to prevent the onset of acute and chronic complications, some of them potentially lethal. Replacement of the destroyed β-cells with fresh and vital pancreatic endocrine tissue, either of the whole organ or isolated islets transplantation, started a few decades ago with progressively encouraging results, although exogenous insulin withdrawal was obtained in a minor cohort of the treated patients. The restricted availability of donor organs coupled with general immunosuppression treatment of recipients to avoid graft immune rejection may, at least partially, explain the limited success achieved by these procedures. Results: The introduction of pluripotent stem cells (either of human embryonic origin or adult cells genetically induced to pluripotency) that can be differentiated toward insulin secretory β-like cells could provide an indefinite resource for insulin-producing cells (IPCs). Conclusions: Because the use of human embryos may encounter ethical problems, employment of adult multipotent mesenchymal stem cells (MSCs) extracted from several tissues may represent an alternative option. MSCs are associated with strong immunoregulatory properties that can alter early stages of β-cell-directed autoimmunity in T1D, other than holding the potential to differentiate themselves into β-like cells. Lights and shadows of these new strategies for the potential cure of T1D and their advancement state are reviewed.

P-232 EIF4E1B Contributes to Early Translation Burst for Embryogenesis Whose Deficiency Causes Embryo Development Arrest at Four-Cell Stage during Oocyte to Embryo Transition in Women

Abstract Study question What are the effects and corresponding mechanisms of the early burst of translation inhibited during the oocyte-to-embryo transition (OET), which is essential for human embryogenesis? Summary answer EIF4E1B contributes to the early burst of translation for embryogenesis whose deficiency causes embryo development arrest at four-cell stage during OET in women. What is known already The first records of human zygotic genes are observed in late one-cell zygotes, and translation in mammals happens before the activation of zygotic genes. Recently, we identified an oocyte specific role of eIF4E1b in selecting and regulating the translation initiation of individual mRNAs that are involved in cell differentiation, cell cycle regulation, and cell fate determination during OET. The genetic ablation of Eif4e1b in mice resulted in a developmental arrest in the 2-cell phase of embryogenesis. How is the early burst of translation regulated in human embryogenesis remains unknown. Study design, size, duration A total of 236 female Chinese participants who underwent assisted reproductive technology (ART) and experienced at least one cycle of OET defects were recruited from our university-affiliated center from January 2017 to May 2023. 60 frozen human 3 pronuclei (3PN) embryos have been used for this work. The use of human embryos donated for research was allowed by the the Ethics Committee of the Reproductive and Genetic Hospital of CITIC–Xiangya (reference LL-SC-2018-009). Participants/materials, setting, methods All recruited individuals underwent whole-exome sequencing. In vitro transcription and micro-injection were employed to validate the embryo development pattern under different translation inhibition as well as potential effects of the EIF4E1B variant in mouse oocytes. Immunoprecipitation was conducted to investigate the causes of OET failure and identify the ability of eIF4E1B bind with PABPC1L. Additionally, a knock-in (KI) mouse model carrying homozygous Eif4e1bA192T was generated to evaluate female fertility and a more comprehensive mechanism. Main results and the role of chance Translation inhibitor cycloheximide (CHX) and knockdown of different translation initiation factors eIF4Es were administered to human 3 pronuclei (3PN) embryos, starting from the 1C stage. The absence of eIF4E1B was identified as a specific phenotype, leading to developmental arrest at the 1-4C stage, which is consistent with the effects of Translation inhibitor CHX. Additionally, a novel homozygous mutation (c.565G>A; p. Ala189Thr) in EIF4E1B was found within a consanguineous family. This mutation was associated with recurrent four-cell arrests, suggesting a translational regulation role for eIF4E1B from the 1C to 4C stage during OET. The mutated eIF4E1B disrupted the expression and condensate distribution of eIF4E1B. We also confirmed the interaction between eIF4E1B and PABPC1L, with the c.565G>A variant in EIF4E1B impairing their binding ability. Furthermore, KI mice carrying homozygous Eif4e1bA192T partially recapitulated the phenotype resulting from EIF4E1B deficiency. Limitations, reasons for caution More cases are required to demonstrate the association between EIF4E1B variants and phenotypes. Wider implications of the findings By delving deeper into the intricate interactions between basic physiology and clinical characteristics, this research elucidates the crucial role of maternal EIF4E1B in ensuring the early burst of translation for embryogenesis and provide a diagnostic genetic marker for women with OET defects. Trial registration number Not applicable

Stem cell-derived embryo models: moral advance or moral obfuscation?

Stem cell-derived embryo models (SCEMs) are model embryos used in scientific research to gain a better understanding of early embryonic development. The way humans develop from a single-cell zygote to...

The History, Use, and Challenges of Therapeutic Somatic Cell and Germline Gene Editing

ABSTRACT Gene editing is a technology that has been rapidly developing and that has many applications as well as ethical and practical implications. This article is a review that outlines the history of current technology, as well as the advantages and challenges in use for somatic cell and germline gene editing. Clustered regularly interspaced short palindromic repeat (CRISPR) was first introduced in 2002 and initially saw limited use among researchers. However, in 2012, it was discovered that a nuclease associated with CRISPR (Cas9) could be used with guide RNA to cleave double-stranded DNA in specific places, raising the potential for targeted gene editing. Immediately, the scientific community saw endless possibilities of this technology for clinical therapies and treatment of genetic disorders. Currently, more than 110 gene editing–based therapies are in clinical trials, with 2 different treatments already in phase 3 clinical trials. To date, all gene editing therapies that have progressed to clinical trials are somatic cell editing therapies. Germline gene editing, in which changes to genes can be passed to the next generation, is attractive for inherited diseases but has many ethical considerations and challenges that must be addressed before this technology is further developed. One concern is off-target editing events that could involve DNA sequences with high similarity to the target sequence. In addition to this, DNA breaks from Cas9 can result in chromosomal instability and possible abnormalities such as large deletions, translocations, and rearrangements. This could be problematic particularly in germline editing, where the effects are passed down to the next generation. Gene editing does, however, have great potential. Somatic cell gene editing has been successfully used to prevent and treat disease. One advantage of somatic cells is that they can be removed, edited, and returned to the patient to proliferate normally. For the therapies currently in stage 3 clinical trials, there have been few instances of failure to modify the alleles and no evidence of off-target editing using this method. Somatic cell gene editing has successfully been used in animal models and in limited human trials to treat diseases with easily accessible in vivo sites, such as the eye. Germline gene editing has advantages over somatic cell gene editing, as therapies can be developed to permanently correct heritable genetic diseases. It could also be adapted easily during an in vitro fertilization process for parents who are carriers of 1 or more diseases to eliminate the risk of their offspring manifesting the disease. However, germline editing creates changes to the DNA that is then passed to offspring, raising ethical and safety concerns. Many trials in animal models as well as early human clinical trials show promise for these treatments, but challenges remain including costs and logistical considerations such as time, space, and expertise. Another challenge is that because these therapies are targeted, each variation of each disease must be treated differently, with a therapy developed specifically for each disease and potentially even variations of the same disease. This again represents significant challenges related to cost, time, and expertise. Ethical challenges for germline gene editing include the use of human embryos, high rates of off-target editing, and possible severe chromosomal deletions depending on the target. Large chromosomal rearrangements, as required with attempting to eradicate certain diseases, have been recently shown to be more difficult and dangerous than smaller rearrangements. This presents a unique challenge that must be overcome before implementing this technique in any therapies. There are many possibilities and exciting opportunities with gene editing therapies, some of which are closer to fruition than others. We are potentially close to implementing some therapies, such as those for sickle cell disease, while farther from broad use for other therapies. The pace at which this technology has developed is astounding, which brings hope that this research will continue to progress quickly, and we may be closer than we think to effectively treating genetic disease with gene editing technology.

Patentability of Brain Organoids derived from iPSC– A Legal Evaluation with Interdisciplinary Aspects

Brain Organoids in their current state of development are patentable. Future brain organoids may face some challenges in this regard, which I address in this contribution. Brain organoids unproblematically fulfil the general prerequisites of patentability set forth in Art. 3 (1) EU-Directive 98/44/EC (invention, novelty, inventive step and susceptibility of industrial application). Patentability is excluded if an invention makes use of human embryos or constitutes a stage of the human body in the individual phases of its formation and development. Both do not apply to brain organoids, unless ES-cells are used. Art. 6 (1) EU-Directive 98/44/EC excludes patentability for inventions “the commercial exploitation of which would be contrary to ordre public or morality”. While there is no conceivable scenario, in which the commercial application of current brain organoids violates the ordre public, the same is not necessarily true for future brain organoids. Keeping in mind that a development of consciousness-like abilities in future brain organoids cannot be excluded and that an ability for both physical and psychological suffering has been theorized, both of which are aspects of the ordre public, certain applications of future brain organoids may constitute a violation of the ordre public and therefore lead to an exclusion of patentability.

Potentiality switches and epistemic uncertainty: the Argument from Potential in times of human embryo-like structures

Recent advancements in developmental biology enable the creation of embryo-like structures from human stem cells, which we refer to as human embryo-like structures (hELS). These structures provide promising tools to complement—and perhaps ultimately replace—the use of human embryos in clinical and fundamental research. But what if these hELS—when further improved—also have a claim to moral status? What would that imply for their research use? In this paper, we explore these questions in relation to the traditional answer as to why human embryos should be given greater protection than other (non-)human cells: the so-called Argument from Potential (AfP). According to the AfP, human embryos deserve special moral status because they have the unique potential to develop into persons. While some take the development of hELS to challenge the very foundations of the AfP, the ongoing debate suggests that its dismissal would be premature. Since the AfP is a spectrum of views with different moral implications, it does not need to imply that research with human embryos or hELS that (may) have ‘active’ potential should be completely off-limits. However, the problem with determining active potential in hELS is that this depends on development passing through ‘potentiality switches’ about the precise coordinates of which we are still in the dark. As long as this epistemic uncertainty persists, extending embryo research regulations to research with specific types of hELS would amount to a form of regulative precaution that as such would require further justification.

O-218 A quantitative investigation into UK public attitudes towards embryo research and the 14-day rule

Abstract Study question Is there UK public acceptance for increased embryo research and the extension of the 14-day rule? Summary answer Respondents broadly supported the use of human embryos in research but believed the 14-day-rule remains ‘about right’. However, this might be extended under certain circumstances. What is known already UK's Human Fertilisation and Embryology Act (1990 as amended) may be reviewed in the near future. The Act currently allows licensed research on embryos up to the equivalent of the 14th day of development. The former PET Patron, the late Baroness Mary Warnock, was largely responsible for establishing the 14-day rule in UK law. The rule was subsequently adopted by many countries and institutions around the world. Baroness Warnock’s work on this issue gave confidence to scientists and the wider public alike. Study design, size, duration This is a quantitative piece of research commissioned by PET. The field work was carried out by Ipsos who interviewed a sample of 2,233 adults aged 16-75 in UK using its online i:omnibus. The responses were gathered between 24 and 27 March 2022. The data has been weighted to the known offline population proportions for age, working status and social grade within gender and Government office region. Participants/materials, setting, methods The principal material used was an online questionnaire developed by PET and its advisers with the input of Ipsos survey research experts. All research was carried out in accordance with the requirements of the international quality standard for market research, ISO 20252, and in accordance with the Ipsos Terms and Conditions. All percentage calculations are rounded up to the nearest whole number. Where percentages do not add up to 100%, this is due to rounding. Main results and the role of chance =Only 11% of respondents could give a scientifically correct definition of a human embryo. =More than 40% of those surveyed said they supported the use of human embryos in scientific and medical research. =44% supported the government funding of such research with 17% being opposed. =Asked whether the 14-day limit is too long, too short or about right, more than half of those who supported (or neither opposed nor supported) the use of laboratory-created human embryos in research responded that the limit was about right. =Those not implacably opposed to embryo research were willing to countenance an extension to the ‘14- day rule’, if reasons were presented to them. =This demonstrates the importance of scientists giving a clear explanation of the benefits that such an extension to the 14-day rule may bring. =The most supported reasons for an extension were to find new treatments for congenital diseases, improving medical understanding of stillbirth and miscarriage. =However, with significant numbers remaining neutral or answering, ‘Don’t know’, this situation could change. Public education is vital to help people engage. =The sample size of 2233 people allowed for statistically significant differences to be identified and reduced the risk of misleading answers. Limitations, reasons for caution This research is a snapshot in time and public opinion can evolve with new information. A significant number of respondents gave a ‘don’t know’ answers. If these members of the public were to shift their view to either ‘support or opposition’ then the landscape for embryo research could markedly alter. Wider implications of the findings The study suggests there is limited public understanding of this subject, as illustrated by only 11% of respondents selected the scientifically correct definition of an embryo. This gap in knowledge makes it challenging to have a meaningful national debate on the potential changes to the current law. Trial registration number Trial registration number is not applicable. PET are grateful for the generous support of Ferring without which it would not have been possible to conduct this piece of wide-ranging, nationally representative research.

O-003 Mechanics of human embryo compaction

Abstract Study question How the human embryo builds the blastocyst is crucial to improve ART, as morphology of human embryo is a prime determinant to assess implantation potential. Summary answer An evolutionarily conserved increase in cell contractility is required to generate the forces driving the compaction, which is the first morphogenetic event shaping the body. What is known already The shaping of the human embryo begins with compaction, during which cells come into close contact and form a tighter structure. ART studies suggest that human embryos fail compaction primarily because of defective adhesion. Based on our current understanding of animal morphogenesis, other morphogenetic engines, such as cell contractility, could be involved in shaping the human embryo. However, the molecular, cellular and physical mechanisms driving human embryo morphogenesis remain uncharacterized. Study design, size, duration A total of 54 frozen embryos have been used for this work. The use of human embryos donated for research was allowed by the Agence de la Biomédecine (approval number RE 17-011R) in compliance with the International Society for Stem Cell Research guidelines. Donated embryos were cryopreserved and stored at three different centers in Paris. Embryos were then transferred to the Institut Curie where they were immediately thawed and used for the research project. Participants/materials, setting, methods Using micropipette aspiration on human embryos, we mapped cell surface tensions during compaction. Drug inhibition and immunostaining of cell contractility and cell-cell adhesion in human embryos reveal what drives the surface tension responsible for compaction. To evaluate cell contractility we focused on F-actin and myosin motor proteins, for adhesion we focused on E-cadherin. Main results and the role of chance Mapping cell surface tensions during human compaction reveals a 4-fold increase of tension at the cell-medium interface, from 0.62 ± 0.04 to 2.35 ± 0.08 nN/µm (mean ± SEM of 147 measurements on 10 embryos, Student’s t test p < 10-5), while cell-cell contacts keep a steady tension ∼0.6 nN/µm. Therefore, increased tension at the cell-medium interface drives human embryo compaction, which is qualitatively similar to compaction in mouse embryos (from ∼0.2 to 0.4 nN/µm). Further comparison between human and mouse reveals qualitatively similar but quantitavely different mechanical strategies, with human embryos being mechanically least efficient. Inhibition of cell contractility and cell-cell adhesion in human embryos reveals that, while both cellular processes are required for compaction, adhesion involvement plays a permissive role. Only contractility controls the surface tension responsible for compaction. Interestingly, cell contractility and cell-cell adhesion exhibit distinct mechanical signatures when faulty. Analyzing the mechanical signature of naturally failing embryos, we find evidence that non-compacting embryos or partially compacting embryos with excluded cells have defective contractility. Limitations, reasons for caution Given the need to use embryos donated to research, which are valuable samples, our sample size is small but sufficient to show statistically significant differences. Moreover, these embryos come from infertile patients undergoing ART. Wider implications of the findings Excluded cells from compaction could be aneuploid to protect the embryonic tissue from chromosomal abnormalities. Is there a correlation between their mechanical signature and the fact that they may be aneuploid remains an open question. How physical laws are used to produce the breathtaking diversity of the shapes of life? Trial registration number ‘not applicable'

Executive Editor-in-Chief’s introduction for This Special Issue

Executive Editor-in-Chief’s introduction for This Special Issue

Patients’ views on using human embryonic stem cells to treat Parkinson’s disease: an interview study

BackgroundHuman embryonic stem cells (hESC) as a source for the development of advanced therapy medicinal products are considered for treatment of Parkinson’s disease (PD). Research has shown promising results and opened an avenue of great importance for patients who currently lack a disease modifying therapy. The use of hESC has given rise to moral concerns and been the focus of often heated debates on the moral status of human embryos. Approval for marketing is still pending.ObjectiveTo Investigate the perspectives and concerns of patients with PD, patients being the directly concerned stakeholders in the ethical discussion.MethodsQualitative semi-structured interviews related to this new therapy in seventeen patients from two Swedish cities.ResultsThe participants expressed various interests related to the use of human embryos for development of medicinal therapies; however, overall, they were positive towards the use of hESC for treatment of PD. It was deemed important that the donating woman or couple made the choice to donate embryos voluntarily. Furthermore, there were concerns that the industry does not always prioritise the patient over profit; thus, transparency was seen as important.

Biomedicine and the challenge to Christian values: Orthodox bioethics in the age of biomedical technologies

For thirty years Russia has been living under the conditions of a market economy, and the age of biomedical technology has coexisted for the same amount of time. The Orthodox community views the progress of biomedicine as a challenge to Christian values that needs adequate ethical reflection and response. The response to this challenge is articulated by Orthodox bioethics, which is a systematic knowledge of the boundaries of permissible biomedical manipulation of human life and death. Orthodox scientists who develop bioethics see their task as protecting human dignity, the traditional family, and other Christian values from the dangers posed by the consequences of the spread of new technologies. Ethical problems associated with the spread of in vitro fertilisation (IVF) technology continue to be of relevance for Orthodox bioethics all these years, since they allow the manipulation of human embryos not as individuals, but as simple biological objects. Some of the bioethical proposals drafted by Orthodox scientists have been paired with criticisms of emerging legal regulations and government decisions aimed at supporting IVF. Equally important to Orthodox bioethics are the problems associated with the development of transplantology, since in Russia the legal framework allows organ donation from a deceased donor based on the presumption of consent. Now, the field of transplantology continues to be regulated by legal norms adopted in the early 1990s, which explains the willingness on the part of Orthodox scientists to challenge some of these norms.

Human Trophectoderm Spheroid Derived from Human Embryonic Stem Cells.

The use of human embryos for studying the early implantation processes and trophoblast is restricted by ethical concerns. The development of models mimicking the peri-implantation embryos is critical for understanding the physiology of human embryos and many pathophysiological disorders including recurrent implantation failure and miscarriage. Three-dimensional (3D) models of trophoblastic spheroids have been successfully derived from human embryonic stem cells (hESC). Simultaneous activation of the BMP pathway and blockage of the Activin/Nodal pathway favor the differentiation of hESC into trophoblast. Here we describe a 3D trophectoderm differentiation protocol with the use of BAP (BMP4, A83-01, and PD173074) to generate hESC-derived trophectoderm spheroids (BAP-EB). BAP-EB is highly reproducible and exhibits morphological and transcriptomic similarities to human early blastocysts.

Stem Cells Era in Maxillofacial Surgery

Stem cells provide a new era for oral and maxillofacial surgery and reconstruction. Stem cells are colonlogic cells that have the ability to renew themselves and form various predecessors. They are found in common tissues used for wound healing and recovery after injuries. Large numbers of these cells are known to be instantly accessible; no immunological denial or rejection; do not have host disease against graft; Tumorigenesis do not occur; but there are some small ethical problems; The predictable differentiation potential for tissue separation and integration is not surprising. There are two basic types of stem cells, depending on their origin: • Embryonic Stem Cells (ESCs): ESCs are initiated by a fetus that has been fertilized in an in vitro fertilization clinic (100,200 organized cell blastocysts). They are called a pluripotent cell population and are characterized by the ability to maintain the karyotype. ESCs can be divided into the three embryonic cotyledons (ectoderm, endoderm, and mesoderm); and in a culture; they form in colonies. These important highlights make ESCs affordable for future use in regenerative medicine and pharmaceuticals. Still; ethical discussions about the use of human embryos cannot be decided entirely; because in addition to scientific and practical questions, it is also dealt with through religious laws and philosophical reflections on the nature of human life. • Adult stem cells: Adult stem cells are found in fetal and postnatal tissues; They are more specialized (multipotent) cells that participate in the repair and restoration of tissues, as well as in the maturation and aging processes. There are numerous sources of adult stem cells such as bone marrow (BMMSC); Adipose tissue (ATMSCs); Liver; Umbilical cord; and muscles. The intraoral sources are the dental pulp; The periodontal ligaments can also be a source of adult stem cells. Fat and bone marrow stem cells are successful and are produced in the context of restorative work and aesthetics. However, ATMSCs have been less easily obtained without harmful effects on patients. Adipose tissue contains a population of mesenchymal stem cells that can be isolated and differentiated into various cell lines, including osteocytes; Fat cells; and myocytes depending on the culture conditions. These cells are called adipose derived stem cells (ASC). The question arises here is: what do stem cells do? And the answer is so simple when you know that 10 million cells in your body die every minute every day and your own stem cells replace them so you can continue living. Both undifferentiated ATMSC and BMMSC have osteogenic; chondrogenic and lipogenic differentiation potential. Both produce markers that help repair the deformity and have the same morphology; spindle shaped cells. Both appeared to work positively when used in reconstructive treatments. There are some contrasts between them; but the main imperative is; the ease of collection and the lower morbidity on the part of the donor. These two variables were extremely critical and favor the choice between fat and bone marrow for repair. ATMSCs and BMMSCs may be suitable replacements for the traditional intrusive method in the future. A better understanding of stem cell types, different platforms, and the influence of developmental components on the tissue design of different scaffolds, and how growth factors affect the tissue engineering pathway, opens opportunities to monitor recovery of bones and soft defects in the future, thus providing an alternative and innovative treatment for patients with soft / hard tissue defects.

Legal regimes for using human embryos for scientific purposes in the light of the international bodies’ practice

The research on human embryos evolves rapidly, raising a number of ethical and legal issues and directly affecting human rights. Approaches to the legal regulation of human embryo research differ significantly from country to country. Some of them employ prohibitive practices (e.g. Switzerland and Italy), and the others have a regime that allows using embryos for scientific purposes with restrictions of different extent (e.g. the UK and Japan). There is no the international consensus on the issue of human embryo research. The objective of the article is to find out whether there are positions of the international bodies that may become or have already become the general guidance for different countries, allowing therefore to regulate effectively the use of human embryos for scientific purposes.The conclusion is drawn that there are positions of international bodies that may serve as the guidance within the regulation of the area concerned. States may enjoy a wide margin of appreciation within the framework of human embryo research regulation, considering the need to update their regulations regularly to harmonize them with the development of human rights and scientific progress and also to ensure a certain level of the embryo protection.

Human embryo research, stem cell-derived embryo models and invitro gametogenesis: Considerations leading to the revised ISSCR guidelines.

SummaryThe ISSCR Guidelines for Stem Cell Research and Clinical Translation were last revised in 2016. Since then, rapid progress has been made in research areas related to in vitro culture of human embryos, creation of stem cell-based embryo models, and in vitro gametogenesis. Therefore, a working group of international experts was convened to review the oversight process and provide an update to the guidelines. This report captures the discussion and summarizes the major recommendations made by this working group, with a specific emphasis on updating the categories of review and engagement with the specialized scientific and ethical oversight process.

Monkey Embryos Cultured to 20 Days.

Gastrulation is a phase in early mammalian development when the three germ layers are generated and body plan is formed. Although well studied in mice, much less is known about gastrulation in humans. Owing to the lack of access to primary human tissue for study and experimental manipulation, as well as legal and ethical constraints surrounding the use of human embryos, a dissection of the molecular and cellular mechanisms that underlie this process in humans has proven elusive. Nonhuman primates, owing to their relatedness to human species, comprise a tantalizing alternative model system for understanding human biology. Two recent studies have established novel systems to study monkey embryos for 20 days, demonstrating landmark events of early primate embryogenesis with possible relevance to human development. Most strikingly, cells grown in the dish closely resembled cells in in vivo embryos, suggesting that embryo development in a dish might actually be equivalent to that which occurs in vivo. In this piece, the author discusses the tremendous potential of these new methods to unveil insights into mechanisms that mediate primate embryo development. Moreover, repurposing the extended monkey embryo culture methods to create human-monkey embryonic chimeras would aid the development of strategies to create human organs inside livestock species. Finally, the ethical and regulatory issues that emerge from reconsideration of extending time limits for human embryo culture beyond 14 days or primitive streak formation are also briefly considered.

Ethical Guiding Principles of "Do No Harm" and the "Intention to Save Lives" in relation to Human Embryonic Stem Cell Research: Finding Common Ground between Religious Views and Principles of Medical Ethics.

One of the goals of medicine is to improve well-being, in line with the principle of beneficence (do no harm). Likewise, scientists claim that the goal of human embryonic stem cell (hESC) research is to find treatments for diseases. In hESC research, stem cells are harvested from a 5-day-old embryo. Surplus embryos from infertility treatments or embryos created for the sole purpose of harvesting stem cells are used in the research, and in the process the embryos get destroyed. The use of human embryos for research purpose raises ethical concern. In this context, the religious leaders play the role to be the moral compass and "reality check" to engage with the public. In Malaysia, the Ministry of Health has outlined the Guidelines for Stem Cell Research and Therapy, reflecting on Islamic principles. Since there has not been much focus on the viewpoints of other faiths in Malaysia, this study attempts to (i) explore the ethical guiding principles deliberated by religious leaders from the Buddhist, Hindu and Catholic traditions and (ii) identify if there is a common ground between the mainstream religious views and principles of medical ethics, in relation to hESC research. Eleven religious leaders representing the Buddhist, Hindu and Catholic traditions were interviewed. Interestingly, though reasoning of religious leaders came from different angles, their underlying concerns revolve around the values of "do no harm" and "intention to save lives". These values are also the key principles in medical ethics. The findings are applied to answer the question as to whether religious and medical guiding principles can co-exist and complement in ethical decision-making, without compromising the values.

Embryo Experimentation in Buddhist Ethics

The objective of this paper is to explore the Buddhist position particularly within the Mahāyāna sect about the use of human embryos which may be either surplus embryos thawed in the laboratory or embryos cultured for research purposes. Buddhism does not give prominence to any supreme creation whose plan might be distorted by human intervention with nature. Buddhism postulates the cyclic course of human existence as eternal. There is no starting point to the series of lives lived and obviously there is no end. In the Buddhist thought, there is a belief that every individual had existence prior to the present birth. Following this, the paper made a study of the details of the conception and gestation as found in the Buddhist literature and sources. Buddhism aims to do away with pain. Intention is an intrinsic aspect in Buddhism referred to as sankalpa, which is beyond mere goals and objectives. An action is deemed as good karma because of its intentions. To Buddhism, a selfless action gains significance.

The limits of “ordre public” and “morality” for the patentability of human embryonic stem cell inventions

Inventions involving human embryonic stem cells (hESC) have unprecedented potential to improve human life through discovery of new drugs and treatment of incurable neurodegenerative diseases, but at the same time, the use of human embryos in research gives rise to contrasting ethical, moral and religious views on the patentability of such inventions. Whether and to what extent patent offices should take these views into account is an open question. The “ordre public” and “morality” clause in patent law may help us find an answer, but neither the legislator nor courts have clarified the meaning of these vague terms. Judicial interpretation has sometimes increased their ambiguity and raised legal uncertainty for the patentability of hESC inventions. This situation may be desirable in some cases, but not in others where the principles of the legal system as a whole come into play. This paper will shed light on the meaning of “ordre public” and “morality” for hESC inventions by examining patent law in the broader legal framework and emphasizing the interconnectedness of national legal systems in a global market as well as the common interest in healthcare innovations.

Attitudes Towards the Donation of Human Embryos for Stem Cell Research Among Chinese IVF Patients and Students

Bioethical debates on the use of human embryos and oocytes for stem cell research have often been criticized for the lack of empirical insights into the perceptions and experiences of the women and couples who are asked to donate these tissues in the IVF clinic. Empirical studies that have investigated the attitudes of IVF patients and citizens on the (potential) donation of their embryos and oocytes have been scarce and have focused predominantly on the situation in Europe and Australia. This article examines the viewpoints on the donation of embryos for stem cell research among IVF patients and students in China. Research into the perceptions of patients is based on in-depth interviews with IVF patients and IVF clinicians. Research into the attitudes of students is based on a quantitative survey study (n=427). The empirical findings in this paper indicate that perceptions of the donation of human embryos for stem cell research in China are far more diverse and complex than has commonly been suggested. Claims that ethical concerns regarding the donation and use of embryos and oocytes for stem cell research are typical for Western societies but absent in China cannot be upheld. The article shows that research into the situated perceptions and cultural specificities of human tissue donation can play a crucial role in the deconstruction of politicized bioethical argumentation and the (often ill-informed) assumptions about “others” that underlie socio-ethical debates on the moral dilemmas of technology developments in the life sciences.