Organoids as hybrids: ethical implications for the exchange of human tissues.

Recent developments in biotechnology allow for the generation of increasingly complex products out of human tissues, for example, human stem cell lines, synthetic embryo-like structures and organoids. These developments are coupled with growing commercial interests. Although commercialisation can spark the scientific and clinical promises, profit-making out of human tissues is ethically contentious and known to raise public concern. The traditional bioethical frames of gift versus market are inapt to capture the resulting practical and ethical complexities. Therefore, we propose an alternative approach to identify, evaluate and deal with the ethical challenges that are raised by the increasing commercialisation of the exchange of sophisticated human tissue products. We use organoid technology, a cutting-edge stem cell technology that enables the cultivation of 'mini-organs' in a dish, as an example. First, we examine the moral value of organoids and recognise them as hybrids that relate to persons and their bodies as well as to technologies and markets in ambiguous ways. Second, we show that commercialisation of organoids is legitimised by a detachment of the instrumental and commercial value of organoids from their associations with persons and their bodies. This detachment is enacted in steps of disentanglement, among which consent and commodification. Third, we contend that far-reaching disentanglement is ethically challenging: (1) Societal interests could be put under pressure, because the rationale for commercialising organoid technology, that is, to stimulate biomedical innovation for the good of society, may not be fulfilled; (2) The interests of donors are made subordinate to those of third parties and the relational moral value of organoids may be insufficiently recognised. Fourth, we propose a 'consent for governance' model that contributes to responsible innovation and clinical translation in this exciting field.

3D Bioprinting Technology: Scientific Aspects and Ethical Issues.

The scientific development of 3D bioprinting is rapidly advancing. This innovative technology involves many ethical and regulatory issues, including theoretical, source, transplantation and enhancement, animal welfare, economic, safety and information arguments. 3D bioprinting technology requires an adequate bioethical debate in order to develop regulations in the interest both of public health and the development of research. This paper aims to initiate and promote ethical debate. The authors examine scientific aspects of 3D bioprinting technology and explore related ethical issues, with special regard to the protection of individual rights and transparency of research. In common with all new biotechnologies, 3D bioprinting technology involves both opportunities and risks. Consequently, several scientific and ethical issues need to be addressed. A bioethical debate should be carefully increased through a multidisciplinary approach among experts and also among the public.

Principle of serviceability and gratuitousness in transplantation?

INTRODUCTION: the issue of commercialization of transplantation analyses in the article. Attention is paid to the importance of transplantation as a method of treatment and saving human lives. AIM: the clarify the feasibility of the introduction of donation commercialization as an avenue to solve the shortage of donor organs and means of combating with black organ market and finding alternative avenues solving these problems, which are more morally acceptable for society is the aim of this article. MATERIALS AND METHODS: the experience of foreign countries has been analyses in the research. Additionally, we used data from international organizations, conclusions scientists and report of Global Financial Integrity in the research. RESULTS: it is impossible to solve most problems by means of paid donation. CONCLUSIONS: therapeutic organ and tissue cloning based on genetic technology is the best way out and solving ethical transplantation problems.

Darurah (Necessity) and Its Application in Islamic Ethical Assessment of Medical Applications: A Review on Malaysian Fatwa.

The discovery and invention of new medical applications may be considered blessings to humankind. However, some applications which might be the only remedy for certain diseases may contain ingredients or involve methods that are not in harmony with certain cultural and religious perspectives. These situations have raised important questions in medical ethics; are these applications completely prohibited according to these perspectives, and is there any room for mitigation? This paper explores the concept of darurah (necessity) and its deliberation in the formulation of fatwas on medicine issued by the National Fatwa Council of Malaysia. Darurah has explicitly been taken into consideration in the formulation of 14 out of 45 fatwas on medicine thus far, including one of the latest fatwas regarding uterine donation and transplantation. These fatwas are not only limited to the issues regarding the use of unlawful things as remedies. They include issues pertaining to organ transplantation, management of the corpse and treatment of brain dead patients. While deliberation of darurah in medicine may vary from issue to issue, darurah applies in a dire situation in which there are no lawful means to prevent harm that may be inflicted upon human life. Nevertheless, other aspects must also be taken into the deliberation. For example, consent must be obtained from the donor or his next of kin (after his death) to conduct a cadaveric organ transplantation.

Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland.

This chapter aims to describe and summarize the regulation of gene and cell therapy products in Switzerland and its legal basis. Product types are briefly described, as are Swiss-specific terminologies such as the term "transplant product," which means products manufactured from cells, tissues, or even whole organs. Although some parts of this chapter may show a guideline character, they are not legally binding, but represent the current thinking of Swissmedic, the Swiss Agency for Therapeutic Products. As so far the experience with marketing approval of gene therapy and cell therapy products in Switzerland is limited, this chapter focuses on the regulation of clinical trials conducted with these products. Quality, nonclinical, and clinical aspects are summarized separately for gene therapy products and transplant products.

Tecidos musculoesqueléticos e pele de origem humana: aspectos éticos e legais da produção científica no Brasil / Musculoskeletal tissues and human skin: ethical and legal aspects scientific production of Brazil / Tejidos musculo esqueléticos y piel de origen humano: aspectos éticos y legales de la producción cienofica en Brasil

Este trabalho realizou análise crítica acerca dos padrões éticos e jurídicos de trabalhos envolvendo casos clínicos e pesquisas que utilizaram enxertos de órgãos ou tecidos musculoesqueléticos e cutâneos publicados em revistas nacionais e internacionais, incluindo ainda dissertaçães e teses de universidades brasileiras. Foram utilizadas três bases de dados de 2000 até 2010: Scielo, Medline e Bireme. Concluiu-se que muitas vezes os princípios bioéticos e as normas jurídicas não foram adotados quanto à aquisição, a utilização e o descarte de tecidos musculoesqueléticos e cutâneos utilizados em estudos científicos, demonstrando a necessidade de se evidenciar normas éticas e legais para aqueles profissionais que utilizarão esse tipo de material.

Este trabajo realizó el análisis crítico de los estándares é ticos y jurídicos de trabajos que involucren casos clínicos e investigaciones que utilizaron injertos de órganos o tejidos musculoesqueléticos y cutáneos publicados en revistas nacionales e internacionales, incluyendo también disertaciones y tesis de universidades brasi-leñas. Se utilizaron tres bases de datos desde el año 2000 hasta el 2010: SciELO, MEDLINE y BIREME. Se concluye que a menudo los principios de la bioética y las normas jurídicas no se han adoptado en la adquisición, uso y eliminación de los tejidos musculoesqueléticos y cutáneos utilizados en los estudios cienơficos, lo que demuestra la necesidad de evidenciar las normas éticas y legales para aquellos profesionales que utilizarán ese tipo de materiales.

This study performed a critical analysis about the ethical and legal standards of papers published in national and international journals involving clinical cases and research regarding musculoskeletal and cutaneous organs or tissue grafts, also including dissertations and thesis of Brazilian Universities. Three databases from 2000 to 2010 were used, which are SciELO, MEDLINE and BIREME. It was concluded that in many cases Bio-ethics principles and legal criteria were not adopted regarding acquistion, utilization and disposal of musculoskeletal and cutaneous tissues used in scientific trials, thus demonstrating the need of highlighting ethical and legal standards for those professionals who use this type of material.

[Fetal experimentation, transplantations, cosmetics and their connection with induced abortion]. / Experimentación fetal, trasplantes, cosmética y su relación con el aborto provocado.

The increase in induced abortion produces large numbers of cells, tissues and organs, which are used in several fields of Medicine, either in research or in treatment. The main uses are in Cardiology, Hematology, Metabolism, Embryology, Neurology, Immunology, Ophthalmology, Dermatology and Transplantations. Flavor enhancers and cosmetics also benefit. Utilitarianism has led to an increase in abortion-originated cell and tissue banks. Abortion is justified through the manipulation of language. Vested interests give rise to complicity in researchers and society as a whole. Abortion and tissue 'donation' cannot be split; since fresh tissues are involved there is a symbiotic relationship between them. Valid consent is not possible. A contradiction emerges, the nasciturus is not desired or valued but fetal organs are. When someone is deprived of his rights it is because another wants to enslave them. Research must have a moral base. Knowledge should not be increased at any price. Something that is legal and well intentioned is not always morally acceptable. The duty of omission is applicable. Means to achieve a goal must be ethical means. Educational efforts to restore respect for the human embryo and fetus must be promoted. Technical advances are not always in accordance with human nature and dignity. Research and treatment that do not resort to cells, tissues and organs obtained from induced abortions should be promoted.

Transplantation of a latissimus dorsi flap between identical twins.

We present a case of composite tissue transplantation of a latissimus dorsi flap between monozygotic twins. The recipient twin, a 19 year old male, suffered from a complex spinal kyphoscoliosis for which he had undergone multiple previous operations over many years. Soft tissue breakdown on his back causing metalwork exposure had necessitated the removal of his most recent spinal rod. This in turn led to rapid severe deterioration of his spinal deformity and consequent critical impairment of lung function. Robust soft tissue cover was required urgently in order to allow the insertion of a new spinal rod. His previous surgeries and body habitus precluded an adequate autologous reconstruction. Instead, reconstruction using composite tissue transplantation from his identical twin brother was successfully undertaken. We discuss the ethical, psychological and surgical issues involved in this case.

The regenerative medicine laboratory: facilitating stem cell therapy for equine disease.

This article focuses on the emerging field of equine regenerative medicine with an emphasis on the use of mesenchymal stem cells (MSCs) for orthopedic diseases. We detail laboratory procedures and protocols for tissue handling and MSC isolation, characterization, expansion, and cryopreservation from bone marrow, fat, and placental tissues. We provide an overview of current clinical uses for equine MSCs and how MSCs function to heal tissues. Current laboratory practices in equine regenerative medicine mirror those in the human field. However, the translational use of autologous and allogeneic MSCs for patient therapy far exceeds what is currently permitted in human medicine.

Composite tissue allotransplantation in Europe. Logistics and infrastructure of a centre.

BACKGROUND: Composite Tissue Allotransplantation (CTA) is a new medical field of growing importance. This paper focuses on the infrastructure and organisation of European CTA centres and discusses the differences between national health systems. MATERIAL/METHODS: Eight European centres (Valencia, Innsbruck, Munich, Lyon, Amiens, Creteil, Wroclaw, Monza) were sent with a specially-designed, standardized, 20-item questionnaire. RESULTS: Five of the eight centres returned our questionnaire: Munich, Innsbruck, Lyon, Amiens, Wroclaw. Since 1998, CTA has been performed at these centres. In both French centres and the Polish centre public funding is available in addition to the coverage provided by health insurers. In Munich the costs for a double upper-arm transplantation were Euro 150,000 with an additional Euro 50,000-70,000 per year. In Lyon the costs for a singular hand transplantation were Euro 70,000 per year and in Wroclaw (Poland) the costs for a hand or upper arm transplantation were Euro 20,000-30,000. As many as 17 different medical professions are involved in the CTA at the different centres. CONCLUSIONS: CTA is an innovative promising therapeutic tool that is based on the experiences of solid organ transplantation and profound microsurgical skills. Due to the complexity of the infrastructure, sourcing and the organisation CTA can only be successfully performed at specialized centres. A European network with an international European waiting list and a central coordination for CTA should be established. In order to advance CTA as an important tool in reconstructive surgery we must turn our attention to how the costs will be met, the legal environment for procurement of adequate donors and open ethical questions.

Composite tissue allotransplantation: hand transplantation and beyond.

Recent advances in transplant immunology are shifting the focus from immunosuppression to immunoregulation, making composite tissue allotransplantation with novel and less potent immunosuppressive regimens a possibility. Hand transplantation has been the most frequently performed human composite tissue allotransplantation, with more than 50 upper extremity-based transplants done worldwide. Further research is needed regarding immunomodulating protocols, and careful oversight and individualized screening procedures will be required as patients seeking improved quality of life through human composite tissue allotransplantation come to accept a certain level of risk in these experimental procedures. Still, composite tissue allotransplantation offers to advance transplant medicine and reconstructive surgery.

Informed consent to tissue donation: policies and practice.

Nearly 10 years ago, the tissue industry's informed consent practices with donor families in the United States were criticized. In response, the industry, along with the Inspector General of the Department of Health and Human Services, suggested elements to be included in the informed consent process. This study examines which of these elements were present in the informed consent documents of 45 (78%) of the nation's 58 Organ Procurement Organizations (OPOs). Some elements, such as involvement of for-profit companies, were present in almost all. Others, such as labeling tissue as a gift from donor families, never were. The authors conclude that the time is ripe for reexamination of the informed consent process with an eye to meaningful consent that promotes the benefits of tissue transplantation and at the same time protects the rights and interests of donor families; can be realistically implemented; and, maintains the trust of the American public.