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Published onAug 03, 2022

9 Wake Forest Intell. Prop. L.J. 215

“Regenerative medicine” describes a set of innovative approaches to the treatment of illness, injury, and disability, focusing on the growth, replacement, and repair of cells, organs, and tissues specific to the health needs of particular individuals. The extraordinary breadth of application of this approach is clear from an enumeration of just a few areas of regenerative medicine research, such as stem cells, including embryonic stem cells, pluripotent stem cells produced by genetic reprogramming, and multipotent stem cells from non-embryonic tissues; techniques for stimulating endogenous cell growth and repair for the kidney and pancreas in diabetes, or for digits and limbs injured as a result of trauma; and the growth of replacement tissues and organs, for example, blood vessels, hollow organs like the bladder, and even solid organs like the heart. This enormous diversity of applications, all currently in various stages of research and development, stems from a multidisciplinary research orientation incorporating genetics, informatics, basic research into the structure, mechanics, and development of different tissues, and creative production techniques. Despite its enormous promise, however, at this time regenerative medicine’s many applications constitute a very early step along the road to effective treatments.

Most of the attention to ethical issues in regenerative medicine has been consumed by debate about the use of human embryonic stem cells in research, specifically, the destruction of embryos in order to create cell lines, disputes over the role of federal funding for research with human embryonic stem cells, and concerns about the safety, scientific purity, and adequacy of consent for the research use of human embryonic stem cell lines. Like other novel biotechnologies, however, regenerative medicine raises a number of additional critical research ethics issues that are not new, but that have not yet been adequately addressed. Instead, as is common in new science, familiar and longstanding questions appear in the fresh context of regenerative medicine research and renew old debates. Advances in regenerative medicine therefore provide a much-needed opportunity to reexamine important issues in human subjects research. Moreover, because regenerative medicine has taken a thoroughgoing translational perspective, seeking to anticipate and plan for the issues (scientific, policy, and practical) that are likely to arise along the full research trajectory from bench to bedside to clinical product, it presents a model system for comprehensively identifying and addressing issues and needs in ethics and policy as they arise in translational research involving this developing science.

This article discusses some of the novel technologies within regenerative medicine. The article then examines the range of ethical issues raised by each novel regenerative medicine technology, including but not limited to: the ethics of research design; issues to consider in first-in-humans regenerative medicine research; and informed consent and the therapeutic misconception. The article further considers whether regenerative medicine helps to blur any distinction that may exist between medical treatment and enhancement, possibly creating more ethical issues to address in the long term. The article concludes by advising scholars and policymakers in bioethics to take the opportunity offered by regenerative medicine to move research ethics and policy forward by examining these issues anew through the lens of this groundbreaking medical science.

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