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The translation of Regenerative medicine (RM) technologies, such as cell-based interventions, biomaterials, and tissue engineering, to patients is increasingly considered. RM is an umbrella term for the research and clinical applications that share the scientific aspiration to restore the original function of damaged or diseased tissue by stimulating the body’s own repair. In order to guarantee responsible research and innovation, this thesis systematically identifies and analyzes the ethical challenges involved in the translation into clinical trials and society. The field of orthopedics is used as an exemplary case since this field is at the front row of RM research. The scope of indications for RM in orthopedics is large and diverse, extending from interventions for degenerative disorders, such as osteoarthritis and intervertebral disc disease, to interventions for (traumatic) defects, such as bone, meniscal and cartilage defects. While the field of orthopedics, but also the cardiovascular field, are used as an example, this thesis is relevant for other medical domains as well. One of the main findings of this thesis is that conducting early orthopedic RM clinical trials is challenging both due the climate of high expectations in which RM trials need to be conducted as well as due to concrete ethical challenges. These ethical challenges concern the assessment of risks and benefits; designing a study in terms of outcome measures and comparators; and participant selection. These are no different from “traditional” drug trials, although RM technologies place those challenges in a new context. Furthermore, this thesis shows that similar ethical challenges appeared to arise in cardiovascular RM trials, as in orthopedic RM trials. Nevertheless, these patient populations and the accompanying RM interventions also differ and therefore give a specific twist to some of these challenges. Furthermore, this thesis shows how the translation of RM technologies can be accompanied with ethics research. This so-called parallel ethics research allows ethicists to influence the technology development and thereby stimulate responsible translation of RM technologies. To assure responsible research, anticipation and reflection is required on both the ethical challenges in the design of clinical trials as well as the societal impacts of the technology. This complies with the constructivist view on science and society that technology development is influenced by other factors than purely scientific aspects.For assessment of these societal impacts it is essential to involve experts but also the public. In other words, dialogue between stakeholders including technology developers, physicians, ethicists, funders, patient (organizations), and the public, should be established in an early stage of technology development to allow responsible research and innovation of RM technologies. In turn, it allows the public to be better prepared for the technology, and in this way the public will be less surprised by the impact it may have on personal lives and on society as a whole. |
