The necessity for a commitment to beneficence and prudence in clinical innovation with autologous stem cells

Abstract

The term ‘innovation’ is frequently used as a justification for allowing clinicians to offer unproven autologous stem cell-based interventions (SCBI) to their patients. Proponents of this kind of innovation (which we refer to as ‘clinical innovation’) argue that that physicians should be free to administer whatever interventions they choose, and informed consumers should be free to receive them. In this article, we refute the notion that clinician autonomy and consumer demand is a sufficient justification for offering patients unproven autologous SCBI. We argue that, while clinician and consumer preferences need to be taken seriously, access to unproven SCBI can only be fully justified when it is based on a commitment to beneficence and prudence. We then argue that there is a need for a clearer distinction between the definition of clinical innovation with autologous stem cells—which is morally neutral—and its justification—which entails a commitment to beneficence and prudence. Finally, we argue that regulation of clinical innovation with autologous stem cells needs to be based on a ‘bioethics of innovation’, which attends to beneficence and prudence alongside other ethical principles.