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

Abstract

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.

Embodiment and regenerative implants: a proposal for entanglement

“…Yet in contrast to regular (inert) implants, regenerative implants are transformed from strange matter into living tissue. Moreover, in contrast to regular (inert) implants, regenerative implants continuously act on and within the body (Parry 2017 ): the implant materials sense and respond to the surrounding tissues, and dynamically interact and ‘communicate’ with the living tissues (De Kanter et al 2023b ). These biodegradative and regenerative processes are ongoing interactions between the implant and body that cannot be actively controlled by the recipient, and which could reinforce the strangeness of the body.…”

“…Eventually, this could lead to estrangement of both the implant and the body: the body fused with the implant could become a stranger to the person itself. As a result, the implant might not be tolerated by the recipient, which could hinder the therapeutic process (De Kanter et al 2023b ). Also, if the tissue is successfully regenerated, the recipient may still experience a sense of unease or discomfort with their body, and the aims of the treatment, e.g.…”

Research Trends in Lung Organoids: Bibliometric Analysis and Visualization

“…Organoid technology can be combined with 3D bioprinting technology [46], micro uidic chip technology [78], and other bioengineering technologies to make organoids more bionic in structure and more mature in function, so as to realize multi-system [79] However, it should be noted that because lung organoids involve personal information and biological sample data, relevant applications also face many ethical challenges [81]. Due to the lack of relevant laws, regulations, and management measures for human organoid banks, it is morally acceptable for organoid parties to distribute bene ts and how to use patent rights to guide technological innovation to the maximum extent under the premise of protecting the rights and dignity of subjects [31]. It also depends on empirical research on the attitudes and cognition of relevant parties and in-depth ethical exploration and demonstration to obtain a scienti c and effective solution [85].…”

“…The United States (177), China (79), Japan (35), the Netherlands (32), and Germany (31) produced the most research. Since 2014, the number of articles published annually in the USA has increased rapidly.…”

“…Cooperation between institutions is more domestic and less transnational. As this area of research involves national bioinformation security and many ethical issues [31,32], future research collaborations are likely to be concentrated within countries.…”