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"Regenerative Medicine ethics."
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Regenerative Urology Clinical Trials: An Ethical Assessment of Road Blocks and Solutions
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.
Journal Article
3D bioprint me: a socioethical view of bioprinting human organs and tissues
In this article, we review the extant social science and ethical literature on three-dimensional (3D) bioprinting. 3D bioprinting has the potential to be a ‘game-changer’, printing human organs on demand, no longer necessitating the need for living or deceased human donation or animal transplantation. Although the technology is not yet at the level required to bioprint an entire organ, 3D bioprinting may have a variety of other mid-term and short-term benefits that also have positive ethical consequences, for example, creating alternatives to animal testing, filling a therapeutic need for minors and avoiding species boundary crossing. Despite a lack of current socioethical engagement with the consequences of the technology, we outline what we see as some preliminary practical, ethical and regulatory issues that need tackling. These relate to managing public expectations and the continuing reliance on technoscientific solutions to diseases that affect high-income countries. Avoiding prescribing a course of action for the way forward in terms of research agendas, we do briefly outline one possible ethical framework ‘Responsible Research Innovation’ as an oversight model should 3D bioprinting promises are ever realised. 3D bioprinting has a lot to offer in the course of time should it move beyond a conceptual therapy, but is an area that requires ethical oversight and regulation and debate, in the here and now. The purpose of this article is to begin that discussion.
Journal Article
The Progression of Regenerative Medicine and its Impact on Therapy Translation
Despite regenerative medicine (RM) being one of the hottest topics in biotechnology for the past 3 decades, it is generally acknowledged that the field’s performance at the bedside has been somewhat disappointing. This may be linked to the novelty of these technologies and their disruptive nature, which has brought an increasing level of complexity to translation. Therefore, we look at how the historical development of the RM field has changed the translational strategy. Specifically, we explore how the pursuit of such novel regenerative therapies has changed the way experts aim to translate their ideas into clinical applications, and then identify areas that need to be corrected or reinforced in order for these therapies to eventually be incorporated into the standard‐of‐care. This is then linked to a discussion of the preclinical and postclinical challenges remaining today, which offer insights that can contribute to the future progression of RM.
Journal Article
Bone regeneration: stem cell therapies and clinical studies in orthopaedics and traumatology
• Introduction • Characterization of cells for bone regeneration in human beings • State of the art in bone tissue engineering ‐ Biomaterials for scaffolding mesenchymal stem cells ‐ Future trends in bone tissue engineering • Clinical targets for cell therapy in orthopaedics ‐ Current clinical problems and therapeutic approaches ‐ Potential clinical applications of cell based therapies for bone repair ‐ Data reported in clinical studies • Selected paediatric bone disorders and cellular therapies ‐ Inborn errors of bone metabolism and cellular therapy ‐ Degenerative bone disorders in childhood • Ethical aspects of EU clinical trials ‐ Ethics related to information and consent ‐ Approval of the studies ‐ Ethics related to privacy/data protection ‐ Ethics related to the risk‐benefit assessment ‐ Ethics related to protection of the health of persons involved in clinical trials ‐ Ethics related to transparency regarding research results • Future directions and remarks 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.
Journal Article
Clinical potentials of human pluripotent stem cells
Aging, injuries, and diseases can be considered as the result of malfunctioning or damaged cells. Regenerative medicine aims to restore tissue homeostasis by repairing or replacing cells, tissues, or damaged organs, by linking and combining different disciplines including engineering, technology, biology, and medicine. To pursue these goals, the discipline is taking advantage of pluripotent stem cells (PSCs), a peculiar type of cell possessing the ability to differentiate into every cell type of the body. Human PSCs can be isolated from the blastocysts and maintained in culture indefinitely, giving rise to the so-called embryonic stem cells (ESCs). However, since 2006, it is possible to restore in an adult cell a pluripotent ESC-like condition by forcing the expression of four transcription factors with the rejuvenating reprogramming technology invented by Yamanaka. Then the two types of PSC can be differentiated, using standardized protocols, towards the cell type necessary for the regeneration. Although the use of these derivatives for therapeutic transplantation is still in the preliminary phase of safety and efficacy studies, a lot of efforts are presently taking place to discover the biological mechanisms underlying genetic pathologies, by differentiating induced PSCs derived from patients, and new therapies by challenging PSC-derived cells in drug screening.
Journal Article
Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials
In the context of regenerative medicine and cellular therapies, the treatment under study often targets a less common disease or condition for which recruitment of a large number of research participants at any given site is challenging, if not impossible. One way to overcome this challenge is with a multi-centre clinical trial. This manuscript first aims to briefly outline the existing ethical, legal and social implications as well as the regulatory frameworks associated with multi-centre regenerative medicine clinical trials. Second, it considers the regulatory limitations and barriers surrounding the initiation of such trials in Canada, the USA and Europe. Third, it concludes with a set of recommendations for facilitating multi-centre clinical trials, at both national and international levels.
Journal Article
U.K. trials of airway transplants are in limbo
Studies are based on flawed evidence and could harm patients, scientists say. Two U.K. clinical trials of stem cell–based airway transplants are in limbo. The studies, led by University College London (UCL) laryngologist Martin Birchall, would take donor larynxes or tracheas from donors, \"seed\" them with a patient's own stem cells, and then transplant them into the patient. The studies have received regulatory approval and ample funding, but they have been on hold since the downfall of former Birchall collaborator Paolo Macchiarini, a surgeon at the Karolinska Institute in Stockholm who has been found guilty of misconduct in more than half a dozen papers. An independent inquiry last year concluded there was no reason to cancel the UCL trials, and the university says they can proceed. But some scientists say the studies are based on flimsy evidence and could harm patients, and two of them have filed detailed complaints with the U.K. Parliament's Science and Technology Committee in an effort to stop the studies.
Journal Article
The Science and Ethics of Induced Pluripotency: What Will Become of Embryonic Stem Cells?
For over a decade, the field of stem cell research has advanced tremendously and gained new attention in light of novel insights and emerging developments for regenerative medicine. Invariably, multiple considerations come into play, and clinicians and researchers must weigh the benefits of certain stem cell platforms against the costs they incur. Notably, human embryonic stem (hES) cell research has been a source of continued debate, leading to differing policies and regulations worldwide. This article briefly reviews current stem cell platforms, looking specifically at the two existing pluripotent lines available for potential therapeutic applications: hES cells and induced pluripotent stem (iPS) cells. We submit iPS technology as a viable and possibly superior alternative for future medical and research endeavors as it obviates many ethical and resource-related concerns posed by hES cells while prospectively matching their potential for scientific use. However, while the clinical realities of iPS cells appear promising, we must recognize the current limitations of this technology, avoid hype, and articulate ethically acceptable medical and scientific goals.
Journal Article