Questions concerning the clinical translation of cell-based interventions under an innovation pathway

Criticisms of the traditional clinical research pathway and its extensive oversight often focus on proposals for deregulation1 or assert that as in clinical treatment, clinical research should always offer benefit to patient-subjects. Proponents of medical innovation take a different, middle path, arguing that innovation is distinguishable from both research and treatment. In addition, adopting an innovation pathway may inadvertently permit the dissemination of ineffective or unsafe interventions to large numbers of patients. Implementing the approach to oversight of innovation that is outlined in the International Society for Stem Cell Research Guidelines seems likely to encounter some understandable practical barriers, given the Guidelines’ lack of procedural specificity. The issue of innovation has attracted serious attention in surgery, at least in part because surgical innovation often arises from repeated application of “variations” first employed as a result of the improvisation necessary to respond to a single patient’s needs.