Framing regenerative medicine: culturally specific stories of an emerging technoscience

Acero, Liliana

doi:10.1057/s41292-021-00236-6

Cited by 1 publication

(2 citation statements)

References 120 publications

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“…Successful TE development co-depends on transdisciplinary collaboration between engineers, scientists, and clinicians 102 , 137 , 232 in a globally inclusive manner 182 , 233 ; adequate training of physician-researchers to gain necessary expertise knowledge and skills to implement TE safely in clinical trials 37 , 121 , 131 , 234 , 235 ; infrastructures of knowledge exchange 106 ; and mutual collaboration and relationships of trust between academia, industry, and regulators. 92 , 125 , 177 , 236 …”

Section: Resultsmentioning

confidence: 99%

“…Next, a wide range of stakeholders, including lay people and patients, should be consulted on their values, needs, expectations, and concerns regarding TE development. 74 , 82 , 88 , 195 , 233 , 248 In particular, such consultation could probe the acceptability of risks, 20 , 237 approaches to deal with uncertainties, 71 and fair distribution of health care resources. 175 , 230 Patient advocates are especially well-positioned to articulate patient needs.…”

Section: Resultsmentioning

confidence: 99%

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The Ethical Implications of Tissue Engineering for Regenerative Purposes: A Systematic Review

Kanter

Jongsma

Verhaar

et al. 2023

Tissue Engineering Part B: Reviews

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Tissue Engineering (TE) is a branch of Regenerative Medicine (RM) that combines stem cells and biomaterial scaffolds to create living tissue constructs to restore patients' organs after injury or disease. Over the last decade, emerging technologies such as 3D bioprinting, biofabrication, supramolecular materials, induced pluripotent stem cells, and organoids have entered the field. While this rapidly evolving field is expected to have great therapeutic potential, its development from bench to bedside presents several ethical and societal challenges. To make sure TE will reach its ultimate goal of improving patient welfare, these challenges should be mapped out and evaluated. Therefore, we performed a systematic review of the ethical implications of the development and application of TE for regenerative purposes, as mentioned in the academic literature. A search query in PubMed, Embase, Scopus, and PhilPapers yielded 2451 unique articles. After systematic screening, 237 relevant ethical and biomedical articles published between 2008 and 2021 were included in our review. We identified a broad range of ethical implications that could be categorized under 10 themes. Seven themes trace the development from bench to bedside: (1) animal experimentation, (2) handling human tissue, (3) informed consent, (4) therapeutic potential, (5) risk and safety, (6) clinical translation, and (7) societal impact. Three themes represent ethical safeguards relevant to all developmental phases: (8) scientific integrity, (9) regulation, and (10) patient and public involvement. This review reveals that since 2008 a significant body of literature has emerged on how to design clinical trials for TE in a responsible manner. However, several topics remain in need of more attention. These include the acceptability of alternative translational pathways outside clinical trials, soft impacts on society and questions of ownership over engineered tissues. Overall, this overview of the ethical and societal implications of the field will help promote responsible development of new interventions in TE and RM. It can also serve as a valuable resource and educational tool for scientists, engineers, and clinicians in the field by providing an overview of the ethical considerations relevant to their work. Impact statement To our knowledge, this is the first time that the ethical implications of Tissue Engineering (TE) have been reviewed systematically. By gathering existing scholarly work and identifying knowledge gaps, this review facilitates further research into the ethical and societal implications of TE and Regenerative Medicine (RM) and other emerging biomedical technologies. Moreover, it will serve as a valuable resource and educational tool for scientists, engineers, and clinicians in the field by providing an overview of the ethical considerations relevant to their work. As such, our review may promote successful and responsible development of new strategies in TE and RM.

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