Regenerative medicine (RM) technologies, such as cell therapy, gene transfer and tissue engineering, are expected to move the field of orthopedics into a new era. Now that more and more attempts are underway to translate preclinical research into clinical studies, it is time to proactively discuss the ethical issues associated with first-in-human applications of RM interventions for musculoskeletal disorders. The design and launch of early clinical trials will be ethically challenging due to the specific features of RM in general, and the application for musculoskeletal disorders specifically. In this paper, we identify three sets of ethical issues that need to be addressed when considering initiating early clinical trials: assessment of risks and benefits; designing a study in terms of outcome measures and comparators; and participant selection. These issues are particularly emphasized in RM research that aims to apply these approaches in an early stage of degenerative musculoskeletal disorders.

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