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The pursuit of sustainable bioinspired materials for regenerative medicine demands a nuanced balance between scientific advancement, ethical considerations, and environmental consciousness. This abstract encapsulates a comprehensive perspective paper exploring the intricate dynamics of toxicology, environmental impact, and ethical concerns within the realm of bioinspired materials. As the landscape of regenerative medicine evolves, ensuring the biocompatibility and safety of these materials emerges as a pivotal challenge. Our paper delves into the multidimensional aspects of toxicity assessment, encompassing cytotoxicity, genotoxicity, and immunotoxicity analyses. Additionally, we shed light on the complexities of evaluating the environmental impact of bioinspired materials, discussing methodologies such as life cycle assessment, biodegradability testing, and sustainable design approaches. Amid these scientific endeavors, we emphasize the paramount importance of ethical considerations in bioinspired material development, navigating the intricate web of international regulations and ethical frameworks guiding medical materials. Furthermore, our abstract underscores the envisioned future directions and challenges in toxicology techniques, computational modeling, and holistic evaluation, aiming for a comprehensive understanding of the synergistic interplay between sustainable bioinspired materials, toxicity assessment, environmental stewardship, and ethical deliberation., (© 2024 IOP Publishing Ltd. All rights, including for text and data mining, AI training, and similar technologies, are reserved.)

Three-dimensional (3D) printing and bioprinting is gaining lot of momentum, especially in surgical specialties. These two technologies have wide array of applications in presurgical, surgical, and in vitro scenarios. Bioprinting can generate customized patient specific tissue engineered from specialized cells. This technology can be a gold standard in reconstructive and regenerative surgeries, if used in regulated and ethical environment. This communication focuses on basics of these technologies, their role in surgical specialties, ethical issues specific to these technologies, and its future.

3D bioprinting involves engineering live cells into a 3D structure, using a 3D printer to print cells, often together with a compatible 3D scaffold. 3D-printed cells and tissues may be used for a range of purposes including medical research, in vitro drug testing, and in vivo transplantation. The inclusion of living cells and biomaterials in the 3D printing process raises ethical, policy, and regulatory issues at each stage of the bioprinting process that include the source of cells and materials, stability and biocompatibility of cells and materials, disposal of 3D-printed materials, intended use, and long-term effects. This chapter focuses on the ethical issues that arise from 3D bioprinting in the lab-from consideration of the source of cells and materials, ensuring their quality and safety, through to testing of bioprinted materials in animal and human trials. It also provides guidance on where to seek information concerning appropriate regulatory frameworks and guidelines, including on classification and patenting of 3D-bioprinted materials, and identifies regulatory gaps that deserve attention.

Stem Cell Research and Tissue Engineering, in present time, have emerged as a legalized and regulated stem cell treatment option globally, but scientifically, their success is unestablished. Novel stem cell-based therapies have evolved as innovative and routine clinical solutions by commercial companies and hospitals across the world. Such rampant spread of stem cell clinics throughout UK, US, Europe and Asia reflect the public encouragement of benefits to incurable diseases. However, ever growing stem cell therapy developments need constant dogwatch and careful policy making by government regulatory bodies for prompt action in case of any untoward public concern. Therefore, researchers and physicians must keep themselves abreast of current knowledge on stem cells, tissue engineering devices in treatment and its safe legal limits. With this aim, stem cell scienctific developments, treatment options and legal scenario are introduced here to beginner or actively inolved scientists and physicians. Introduction to stem cell therapy will provide basic information to beginner researchers and practice physicians on engineered stem cell research concepts and present stem cell therapy federal regulations in different North American, European and Asian countries. FDA, CDC, EU, ICMR government policies in different countries include information on the current legal position, ethical policies, regulatory oversight and relevant laws., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Recent results from studies on animals suggest that functional germ cells may be generated from human pluripotent stem cells, giving rise to three possibilities: research with these so-called artificial gametes, including fertilization experiments in vitro; their use in vivo for therapy for the treatment of human infertility; and their use in assisted reproductive technologies in vitro. While the legal, philosophical, and ethical questions associated with these possibilities have been already discussed intensively in other countries, the debate in Germany is still at its beginning. A systematic and detailed analysis of the legal framework in Germany is provided with regard to the three possibilities, including the applicable statutory laws as well as the constitutional law. The question emerges as to whether the statutory laws as well as the constitution justify a distinction to be made between embryos of artificial and natural origin. This question is subject to philosophical analysis, discussing the distinction between person and thing, dignity and price, personality and property, and nature and technique. As a result, the criterion of naturalness alone may not be sufficient to differentiate between embryos of natural and artificial origin, and other criteria need to be identified., (© 2018 The Authors. Bioethics Published by John Wiley & Sons Ltd.)

Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.

Animal experimentation requires a solid and rational moral foundation. Objective and emphatic decision-making and protocol evaluation by researchers and ethics committees remain a difficult and sensitive matter. This article presents three perspectives that facilitate a consideration of the minimally acceptable standard for animal experiments, in particular, in tissue engineering (TE) and regenerative medicine. First, we review the boundaries provided by law and public opinion in America and Europe. Second, we review contemporary moral theory to introduce the Neo-Rawlsian contractarian theory to objectively evaluate the ethics of animal experiments. Third, we introduce the importance of available reduction, replacement, and refinement strategies, which should be accounted for in moral decision-making and protocol evaluation of animal experiments. The three perspectives are integrated into an algorithmic and graphic harm-benefit analysis tool based on the most relevant aspects of animal models in TE. We conclude with a consideration of future avenues to improve animal experiments.

In this review we aim to provide an overview of the most important ethical pros and cons of stem cell derived gametes (SCD-gametes), as a contribution to the debate about reproductive tissue engineering. Derivation of gametes from stem cells holds promising applications both for research and for clinical use in assisted reproduction. We explore the ethical issues connected to gametes derived from embryonic stem cells (both patient specific and non-patient specific) as well as those related to gametes derived from induced pluripotent stem cells. The technology of SCD-gametes raises moral concerns of how reproductive autonomy relates to issues of embryo destruction, safety, access, and applications beyond clinical infertility.

Biofabrication technologies have the potential to improve healthcare by providing highly advanced and personalized biomedical products for research, treatment and prevention. As the combining of emerging techniques and integrating various biological and synthetic components becomes increasingly complex, it is important that relevant stakeholders anticipate the translation of biofabricated 3D tissue products into patients and society. Ethics is sometimes regarded as a brake on scientific progress, yet from our perspective, ethics in parallel with research anticipates societal impacts of emerging technologies and stimulates responsible innovation. For the ethical assessment, the biofabrication field benefits from similarities to regenerative medicine and an increasing ethical awareness in the development of tissue-engineered products. However, the novelty of the technology itself, the increase in attainable structural complexity, and the potential for automation and personalization are distinguishing facets of biofabrication that call for a specific exploration of the ethics of biofabrication. This review aims to highlight important points of existing ethical discussions, as well as to call attention to emerging issues specific to 3D biofabrication in bench and bedside research and the translation to society.

Tissue engineering research is a complex process that requires investigators to focus on the relationship between their research and anticipated gains in both knowledge and treatment improvements. The ethical considerations arising from tissue engineering research are similarly complex when addressing the translational progression from bench to bedside, and investigators in the field of tissue engineering act as moral agents at each step of their research along the translational pathway, from early benchwork and preclinical studies to clinical research. This review highlights the ethical considerations and challenges at each stage of research, by comparing issues surrounding two translational tissue engineering technologies: the bioartificial pancreas and a tissue engineered skeletal muscle construct. We present relevant ethical issues and questions to consider at each step along the translational pathway, from the basic science bench to preclinical research to first-in-human clinical trials. Topics at the bench level include maintaining data integrity, appropriate reporting and dissemination of results, and ensuring that studies are designed to yield results suitable for advancing research. Topics in preclinical research include the principle of "modest translational distance" and appropriate animal models. Topics in clinical research include key issues that arise in early-stage clinical trials, including selection of patient-subjects, disclosure of uncertainty, and defining success. The comparison of these two technologies and their ethical issues brings to light many challenges for translational tissue engineering research and provides guidance for investigators engaged in development of any tissue engineering technology., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Stem cell research and related initiatives in regenerative medicine, cell-based therapy, and tissue engineering have generated considerable scientific and public interest. Researchers are applying stem cell technologies to chest medicine in a variety of ways: using stem cells as models for drug discovery, testing stem cell-based therapies for conditions as diverse as COPD and cystic fibrosis, and producing functional lung and tracheal tissue for physiologic modeling and potential transplantation. Although significant scientific obstacles remain, it is likely that stem cell-based regenerative medicine will have a significant clinical impact in chest medicine. However, stem cell research has also generated substantial controversy, posing a variety of ethical and regulatory challenges for research and clinical practice. Some of the most prominent ethical questions related to the use of stem cell technologies in chest medicine include (1) implications for donors, (2) scientific prerequisites for clinical testing and use, (3) stem cell tourism, (4) innovation and clinical use of emerging stem cell-based interventions, (5) responsible translation of stem cell-based therapies to clinical use, and (6) appropriate and equitable access to emerging therapies. Having a sense of these issues should help to put emerging scientific advances into appropriate context and to ensure the responsible clinical translation of promising therapeutics.

The increasing globalization of mankind with pluralistic belief systems necessitates physicians by virtue of their profession to partner with bioethics for soundly applying emerging knowledge and technologies for the best use of the patient. A subfield within medicine in which this need is acutely felt is that of surgical implants. Within this subfield such recent promising ethics and medicine partnerships include the International Tissue Engineering Research Association and UNESCO Chair in Bioethics and Human Rights' International Code of Ethics. In this paper, we provide an overview of the emerging human rights framework from bioethics and international law, discussion of key framework principles, their application to the current surgical challenge of implantation of surgical mesh for prolapse, and conclusions and recommendations. Such discussions are meant to facilitate true quality improvement in patient care by ensuring the exciting technologies and medical practices emerging new daily are accompanied by an equal commitment of physicians to ethically provide their services for the chief end of the patient's good.

Tissue engineering (TE) is a scientific field that will have an influence on our daily lives. It has the potential to revolutionize medical treatments, but it has also an impact on our human image and is associated with potential risks and ethical aspects. Among the publicly controversial issues are embryonic and induced pluripotent stem cells, cloning, uncertainties regarding risks and informed consent issues. To maintain public confidence in the science of TE, a good solution is public dialogues with patients and other interested lay people that gives the public the chance to independently evaluate TE issues and build their own opinion based on information from different perspectives. The article describes public participation projects in TE on stem cell research and gene therapy and presents the case study of the EU-Gene Activated Matrices for Bone and Cartilage Regeneration on Arthritis (GAMBA) panels, a dialogue with patient and citizen panels in three European countries. In the GAMBA panels, lay participants assessed the basic research project aimed at finding ways of healing osteoarthritis through a matrix composed of adult stem cells, gene vectors, nanoparticles, and biomaterials. The results of the dialogues in different countries, such as Denmark, Japan, Ireland, Switzerland, and Germany, are compared and the evaluation criteria for high quality dialogues are presented, including multiperspectivity, openness of results, a clear mandate, impartial facilitation of the panels, and transparency.

Scientific progress and the development of new technologies often incite enthusiasm, both in scientists and the public at large, and this is especially apparent in discussions of emerging medical technologies, such as tissue engineering (TE). Future-oriented narratives typically discuss potential applications with much hype and expectations. In this article, we analyze the discourse on TE, its history and the promises present in the discourse surrounding it. Subsequently, we regard discussions about implantable bioartificial kidneys, and consider the concepts of hype and expectations in TE in general. Finally, we discuss what ethically responsible choices should be made in discussing TE to adequately deal with the scientific reality and public expectations surrounding this technology.

This article analyses some popular cultural representations of biotechnology, especially the artistic work of the Australian artist Patricia Piccinini to reflect on the role of law, technology and ethics in relation to bodily material. Her view that "with creation...comes an obligation to care for the result", so evident in her poignant pictures, is a sober reminder to us of our responsibilities in regulating new technologies.

Development of novel prognostic, diagnostic, and treatment options will provide major benefits for millions of patients with acute or chronic respiratory dysfunction, cardiac-related disorders, esophageal problems, or other diseases in the thorax. Allogeneic organ transplant is currently available. However, it remains a trap because of its dependency on a very limited supply of donated organs, which may be needed for both initial and subsequent transplants. Furthermore, it requires lifelong treatment with immunosuppressants, which are associated with adverse effects. Despite early clinical applications of bioengineered organs and tissues, routine implementation is still far off. For this review, we searched the PubMed, MEDLINE, and Ovid databases for the following keywords for each tissue or organ: tissue engineering, biological and synthetic scaffold/graft, acellular and decelluar(ized), reseeding, bioreactor, tissue replacement, and transplantation. We identified the current state-of-the-art practices in tissue engineering with a focus on advances during the past 5 years. We discuss advantages and disadvantages of biological and synthetic solutions and introduce novel strategies and technologies for the field. The ethical challenges of innovation in this area are also reviewed., (Copyright © 2013 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

In their 2007 paper, Swierstra and Rip identify characteristic tropes and patterns of moral argumentation in the debate about the ethics of new and emerging science and technologies (or "NEST-ethics"). Taking their NEST-ethics structure as a starting point, we considered the debate about tissue engineering (TE), and argue what aspects we think ought to be a part of a rich and high-quality debate of TE. The debate surrounding TE seems to be predominantly a debate among experts. When considering the NEST-ethics arguments that deal directly with technology, we can generally conclude that consequentialist arguments are by far the most prominently featured in discussions of TE. In addition, many papers discuss principles, rights and duties relevant to aspects of TE, both in a positive and in a critical sense. Justice arguments are only sporadically made, some "good life" arguments are used, others less so (such as the explicit articulation of perceived limits, or the technology as a technological fix for a social problem). Missing topics in the discussion, at least from the perspective of NEST-ethics, are second "level" arguments-those referring to techno-moral change connected to tissue engineering. Currently, the discussion about tissue engineering mostly focuses on its so-called "hard impacts"-quantifiable risks and benefits of the technology. Its "soft impacts"-effects that cannot easily be quantified, such as changes to experience, habits and perceptions, should receive more attention.

Tissue engineering--part of regenerative medicine--is a promising technology that could potentially offer elegant solutions to urogenital defects, but so far, it has fallen short of its potential. Within experimental studies for bladder and urethra reconstructions, two clinical applications have been described, but extension of these techniques to the broader urological patient population has not happened so far. In this article, we aim to identify the ethical road blocks in the clinical evaluation of tissue-engineered products under the European Medicines Agency and Food and Drug Administration regulations for pediatric urological conditions and, ultimately, to recommend strategies to overcome them. The use of human tissue-engineered products (HTEPs) to treat children with congenital urogenital defects poses challenges in the clinical testing phase, connected to three features of the application of this treatment in this patient group: (1) those associated with the product, namely, the multifaceted complexity of the HTEP; (2) those connected to the procedure, namely, the lack of a randomized controlled trial (RCT)-tested gold standard to compare the new treatment to and difficulties surrounding standardization of the treatment protocol; and (3) the patient's young age and associated problems concerning possible long-term effects and the informed consent process. Due to these problems, a conventional RCT is not the methodology of choice to evaluate this treatment in this patient group. The unpredictability of HTEPs necessitates stringent and long-term surveillance and registry to ensure the safety of patients treated with these products.

The subject of biomaterials science concerns artificial materials used in medical devices to repair or reconstruct natural human tissue damaged by disease or trauma. It embraces the emerging field of tissue engineering, where artificial materials are used as scaffolds to provide the architecture for replacement organs. As such, the field raises numerous ethical issues, which are reviewed in this paper. These include the use of animal models, the testing materials and devices in patients, and what may be viewed as potential abuses, where augmentation and repair are carried out for cosmetic as opposed to clinical reasons. The paper gives detailed consideration of the recent problems of metal-on-metal hip replacements as an exemplar of some of the key ethical issues that arise in this field.

The first trials using progenitor cells to improve burn wound healing are beginning. However, there remains a paucity of data on patients' opinions of the source of stem cells. In this study, 279 patients attending plastic surgery/burns outpatient and medical outpatient clinics were questioned to assess willingness to accept a tissue-engineered skin product derived from a variety of sources. Levels of acceptance for the use of progenitor cells derived from these sources for treatment across a range of disease states (burns, Parkinson's disease, diabetes, and for cosmetic use) were also assessed. Overall, 80% of those questioned would accept a tissue-engineered product. Autologous cells were the preferred choice of cells (acute burns 94%, diabetes 95%, Parkinson's 93.9%). Allogeneic cells were still widely accepted (acute burns 67%, diabetes 66.7%, Parkinson's 69.2%). There was no difference observed between plastic surgical patients and medical patients in acceptance of cell therapy for burns, Parkinson's disease, or diabetes. There is good potential acceptance for the use of both autologous and allogeneic cells for the treatment of acute burns and burns' scarring as well as in diabetes and Parkinson's disease. Disease state does not appear to influence overall acceptability and choice of cells., (© 2012 by the Wound Healing Society.)

This article is part of the EuroSTEC project, which aims at developing tissue engineering-based treatments for structural disorders present at birth. EuroSTEC is positioned at the intersection of three areas with their own ethical issues: (1) regenerative medicine, (2) research with pregnant women and fetuses, and (3) research with neonates. Because of the link between these three areas in this project, one can expect to be confronted with new ethical challenges. To be able to respond adequately and timely to current and possible future ethical issues, a prospective and anticipatory ethical analysis is essential. To obtain a first impression of the ethical issues that might arise during the different phases of the project, a Delphi method was used. On the basis of the results of two previous rounds of questionnaires, two topics were selected for discussion in focus groups: ethical issues associated with (1) source of cells and (2) donation. The results could be divided into three clusters: Tissue, Donor, and Scientist. Where the former two clusters roughly coincide with the results of the previous rounds, the third subject was entirely new but discussed by both groups: the role of the scientist in the tissue engineering process.

Advanced therapy medicinal products (ATMP) are associated with high expectations because they offer new opportunities for the treatment of diseases, e.g., the possibility of regenerating damaged or lost tissue. What the products (gene therapy, somatic cell therapy, and tissue engineered products) have in common is an innovative and complex development process that combines science and engineering. At the same time, this field of research is becoming increasingly interdisciplinary and requires international cooperation. A comprehensive assessment of ATMP has to take these issues into account. The application of Beauchamp and Childress' Four Principles (Principle-Based Ethics) as well as Discourse Ethics as a framework may lead to a broader consideration of medical ethics issues.

Regenerative medicine seeks to repair or replace damaged tissues or organs, with the goal to fully restore structure and function without the formation of scar tissue. Cell based therapies are promising new therapeutic approaches in regenerative medicine. By using mesenchymal stem cells, good results have been reported for bone engineering in a number of clinical studies, most of them investigator initiated trials with limited scope with respect to controls and outcome. With the implementation of a new regulatory framework for advanced therapeutic medicinal products, the stage is set to improve both the characterization of the cells and combination products, and pave the way for improved controlled and well-designed clinical trials. The incorporation of more personalized medicine approaches, including the use of biomarkers to identify the proper patients and the responders to treatment, will be contributing to progress in the field. Both translational and clinical research will move the boundaries in the field of regenerative medicine, and a coordinated effort will provide the clinical breakthroughs, particularly in the many applications of bone engineering., (© 2011 The Authors Journal of Cellular and Molecular Medicine © 2011 Foundation for Cellular and Molecular Medicine/Blackwell Publishing Ltd.)

Numerous studies have confirmed that stem cell therapy has significant potential for the regeneration of congenital and acquired heart diseases. The utilization of embryonic stem cells and induced pluripotent stem cells promises a possible generation and regeneration of all cardiovascular structures. On the one hand fetal and adult stem cells, e.g. endothelial progenitors, mesenchymal, hematopoietic, cardiac stem cells and myoblasts, possess limited potential for multilinear differentiation. On the other hand these cells have high paracrin activity and support with well-confirmed safety the reconstruction and formation of cardiovascular structures. On the visionary track towards an autonomously functioning autologous heart generated by tissue engineering, vascular, valvular and myocardial tissues have already been successfully created. This manuscript describes the possible stem cell sources for cardiovascular tissue engineering and evaluates their potency and safety from a medical and ethical point of view employing the data from systematic reviews (Medline database) and own investigations.

This article is part of the EuroSTEC project, which aims at developing tissue engineering-based treatments for structural disorders present at birth. EuroSTEC is positioned at the intersection of three areas with their own ethical issues: (1) regenerative medicine, (2) research with pregnant women and fetuses, and (3) research with neonates. Because of the overlap of these three areas in this project, we can expect to be confronted with new ethical challenges. To be able to respond adequately and timely to current and possible future ethical issues, a prospective and anticipatory ethical analysis is essential. To obtain a first survey of ethical issues that might arise during the different phases of the project, the Delphi method was used. The professionals directly involved in the EuroSTEC project were questioned about their views on possible ethical issues. The first round yielded 27 ethical issues, which the respondents were asked to prioritize in the second round. For the fundamental research phase, issues deemed most important were privacy and informed consent of the tissue donor. For the animal experimentation phase, three issues were mentioned (in order of decreasing priority): the suffering of animals, the use of animals as means to an end, and the limited adequacy of the animal models. Issues that were deemed most important during the clinical (trial) phase pertained to the problem of weighing risks and benefits for the fetus/child and the pregnant woman.

In this article the scope and contents of informed consent for cell donation in tissue engineering are discussed. We evaluate the various values donors may attach to cells and that may influence their decision to donate. Awareness of the various meanings of the value of the cells is therefore essential for all involved in cell transfer. We discuss four types of value: biological, relational, material and informational value and discuss their relevance for collection, for the relationships that are established between donor and cell collector and for informed consent procedures. The actual setting of cell donation and the contents of informed consent can either maintain or disrupt these relationships. While one can exclude donors from any further say in the destination of their cells and from any financial return, one cannot exclude them from a persistent interest in the genetic information of the cells.

Ex-vivo tissue engineering is a quickly developing medical technology aiming to regenerate tissue through the introduction of an ex-vivo created tissue construct instead of restoring the damaged tissue to some level of functionality. Tissue engineering is considered by some as a new medical paradigm. We analyse this claim and identify tissue engineering's fundamental characteristics, focusing on the aim of the intervention and on the complexity and continuity of the process. We inquire how these features have an impact not only on the scientific research itself but also on the ethical evaluation of this research. We suggest that viewing tissue engineering as a new medical paradigm allows us to develop a wider perspective for successful investigation instead of focusing on isolated steps of the tissue engineering process in an anecdotal way, which may lead to an inadequate ethical evaluation. We argue that the concept of tissue engineering as a paradigm may benefit the way we address the ethical challenges presented by tissue engineering.

We present the first exploratory survey about the views of tissue engineers on the ethical issues of tissue engineering (TE), conducted among participants of a large European TE consortium. We analyzed the topics for which ethical guidance is necessary and the preferred dissemination channels, which are relevant issues and goals of clinical trials with human tissue-engineered products, and which information is to be given to trial participants. The need for comprehensive, specific ethical guidance of TE is a first key finding of this survey. Second, it becomes clear that little clarity exists on some crucial issues in the setup and conduct of clinical trials in TE. Identifying the unique features of TE and their repercussions for the ethical conduct of TE research and therapy is necessary. Third, prospective trial participants are to be informed about a wide variety of issues before taking part in the trial.

The success of regenerative endodontic procedures requires practitioner acceptance, but little or no evidence is available. The purpose of this survey was to collect the opinions of attendee's of the 2008 Endodontic Board of Diplomates 2008 Summer Conference on the issue of regenerative endodontic procedures (REPs). After Nova Southeastern University institutional review board approval, 100 copies of a survey were circulated, and 56 completed surveys were returned anonymously. The survey found that 96% of participants thought that more regenerative therapies should be incorporated into treatments. Although only 14% of participants had used umbilical cord or stem cell banking for themselves or a relative, 63% thought that stem cell banking would be useful to regenerate dental tissues. Most (89%) of the participants would be willing to save teeth and dental tissues for stem cell banking. These results suggest that endodontic practitioners are supportive and optimistic about the future use of REPs.

In his 1987 book Controlling Life: Jacques Loeb and the Engineering Ideal in Biology, Philip Pauly presented his readers with the biologist Jacques Loeb and his role in developing an emphasis on control of life processes. Loeb's work on artificial parthenogenesis, for example, provided an example of bioengineering at work. This paper revisits Pauly's study of Loeb and explores the way current research in regenerative medicine reflects the same tradition. A history of regeneration research reveals patterns of thinking and research methods that both echo Loeb's ideology and point the way to modern studies. Pauly's work revealed far more than we readers realized at the time of its publication.

The shortage of donors for organ transplantation has stimulated research on stem cells as a potential resource for cell-based therapy in all human tissues. Stem cells have been used for regenerative medicine applications in many organ systems, including the genitourinary system. The potential applications for stem cell therapy have, however, been restricted by the ethical issues associated with embryonic stem cell research. Instead, scientists have explored other cell sources, including progenitor and stem cells derived from adult tissues and stem cells derived from the amniotic fluid and placenta. In addition, novel techniques for generating stem cells in the laboratory are being developed. These techniques include somatic cell nuclear transfer, in which the nucleus of an adult somatic cell is placed into an oocyte, and reprogramming of adult cells to induce stem-cell-like behavior. Such techniques are now being used in tissue engineering applications, and some of the most successful experiments have been in the field of urology. Techniques to regenerate bladder tissue have reached the clinic, and exciting progress is being made in other areas, such as regeneration of the kidney and urethra. Cell therapy as a treatment for incontinence and infertility might soon become a reality. Physicians should be optimistic that regenerative medicine and tissue engineering will one day provide mainstream treatment options for urologic disorders.

The objective of tissue engineering is to create living body parts that will fully integrate with the recipient's body. With respect to the ethics of tissue engineering, one can roughly distinguish two perspectives. On the one hand, this technology is considered morally good because tissue engineering is 'copying nature'. On the other hand, tissue engineering is considered morally dangerous because it defies nature: bodies constructed in the laboratory are seen as unnatural. In this article, we develop a phenomenological-ethical perspective on bodies and technologies, in which the notion 'lived body' and concrete experiences of health and illness play an important role. From that perspective, we analyse the practice of tissue engineering by focussing on one specific example: the engineering of heart valves. On the basis of this analysis, we propose that the ethics of tissue engineering should be framed not in terms of 'natural' or 'unnatural' but in terms of 'good embodied life' and 'lived integrity'.

Translation from the laboratory to the clinic is one of the key problems of stem cell research. One reason for this is that stem cell science is ethically charged and therefore its successful therapeutic application would support its social legitimacy and further funding. We discuss translation both theoretically and with reference to an example, namely efforts regarding the creation of cardiomyocytes from embryonic stem cell lines with the aim to regenerate a patient's myocardium post trauma. Using this case we explain the facts that need to be established scientifically and the subsequent steps that need to be taken in order to develop and implement clinical application. We also discuss aspects of current scientific development related to the moral charge of the research, in particular emerging methods aimed at the derivation of pluripotent cells, such as the hybridization of human DNA and animal egg cells, or the genetic modification of adult somatic cell nuclei in culture to induce pluripotency.

Ex-vivo tissue engineering is an emerging medical technology. Its aim is to regenerate tissues and organs and to restore them to full physiological activity. Some clinical trials with human tissue engineered products (HTEPs) have been conducted and others will follow. These trials not only have to confirm the therapeutic value of the HTEP, they also have to provide insight in its regenerative activity, its safety and long-term effects. The development of these trials is aggravated by the complexity of the tissue engineering process and product. This paper investigates how this complexity influences the ethical conduct of clinical trials with HTEPs. We focus on the value and validity of the trial, the risk-benefit ratio and the protection of the trial participant. We argue that trials with HTEPs need a robust methodology. The risk-benefit ratio of a new HTEP must be determined and compared with available efficacious therapies. This requires the identification and minimisation of risks associated with tissue engineering. Finally a process as complex as tissue engineering presents serious challenges for the informed consent process, and for the protection of the trial participant during and after the trial.

The discovery of human embryonic stem cells at the end of 1998 had a strong influence on the development of stem cell research and led to controversial discussions. The first therapeutic application of adult blood stem cells began after their discovery in 1963 and was accepted as an authorized therapy in the early 1980s. The way from basic research to therapeutic use needed about 20 years and was also discussed in a controversial way similar to the discussions of today. The regulatory environment at that time, however, allowed a quick translation of the results from basic research to the clinic. Today many new stem cell therapies for a multitude of diseases are under development. Their clinical realization is regulated by the AMG (Arzneimittelgesetz). For nonclinical research as well as for clinical research, specific regulations are enacted to guarantee a structured and safe launch. Time, know how and money for planning, request for authorization and conduction of a clinical trial should not be underestimated. For clinical application of stem cell products authorization by the proper authorities is mandatory.

Ex vivo tissue-engineered products are increasingly entered into clinical trials. To allow prospective participants to make a fully informed, autonomous decision on their participation, we have to adapt the informed consent process by taking the specific aspects of tissue engineering into consideration. New elements in ex vivo tissue engineering are the source and manipulation of the cells in the product, the implantation of the product and the additional risks and benefits due to the construction of the product and its activity in the body. They are the result of the delicate nature of some cell types and of the complexity of the tissue engineering process. The process of informing the participant should be designed in such a way that the participant's capacity to understand the intervention and its implications is enhanced. Crucial issues, such as the aim and procedure of the trial, the risks and benefits involved and the role of the investigator, have to be clarified. We suggest that participants' understanding of the trial can be enhanced through the use of audiovisual material, by developing a simple questionnaire to direct the information process further, and by the assistance of informed third parties to help participants in their decision-making processes., (Copyright (c) 2008 John Wiley & Sons, Ltd.)

Stem cells carry the promise to cure a broad range of diseases and injuries, from diabetes, heart and muscular diseases, to neurological diseases, disorders and injuries. Significant progresses have been made in stem cell research over the past decade; the derivation of embryonic stem cells (ESCs) from human tissues, the development of cloning technology by somatic cell nuclear transfer (SCNT) and the confirmation that neurogenesis occurs in the adult mammalian brain and that neural stem cells (NSCs) reside in the adult central nervous system (CNS), including that of humans. Despite these advances, there may be decades before stem cell research will translate into therapy. Stem cell research is also subject to ethical and political debates, controversies and legislation, which slow its progress. Cell engineering has proven successful in bringing genetic research to therapy. In this review, I will review, in two examples, how investigators are applying cell engineering to stem cell biology to circumvent stem cells' ethical and political constraints and bolster stem cell research and therapy.

The development of tissue engineering in Europe suffers from the absence of a coherent regulatory framework. Therefore, the European Commission has drafted a directive to regulate all tissue-engineered products in a comprehensive yet flexible framework. This article analyzes the directive from an ethical viewpoint. We argue that there are shortcomings to the proposal because of disjunctures at various regulatory levels and because responsibilities of several authorities have not been clearly established. The conscious decision to exclude ethically sensitive issues from the regulation will contribute to a continued complex regulatory environment for tissue-engineered products in Europe. We suggest that, from the start, ethical issues must be considered as an integral part of the regulation of tissue-engineered products. We propose the development of a multistage regulatory framework that makes provision for the diversity of tissue-engineered products, whereby the hybrid character and the ethical sensitivity of these products are fully taken into account. We equally suggest that the general public remain involved in regulatory issues concerning tissue-engineered products.