Unproven stem cell–based interventions and achieving a compromise policy among the multiple stakeholders

Nov 12, 2015

Authors : Kirstin R. W. Matthews and Ana S. Iltis.

Article in BMC Medical Ethics. BMC Medical Ethics 2015, 16:75  doi:10.1186/s12910-015-0069-x

Discussion: In this paper, we argue that the continued marketing and use of experimental stem cell-based interventions is problematic and unsustainable. Central problems include the lack of patient protection, US liability standards, regulation of clinical sites, and clinician licensing. These interventions have insufficient evidence of safety and efficacy; patients may be wasting money and time, and they may be forgoing other opportunities for an intervention that has not been shown to be safe and effective. Current practices do not contribute to scientific progress because the data from the procedures are unsuitable for follow-up research to measure outcomes. In addition, there is no assurance for patients that they are receiving the interventions promised or of what dosage they are receiving. Furthermore, there is inconsistent or non-existent follow-up care. Public policy should be developed to correct the current situation.

This article is part of the series Driving Regenerative Medicine to the Market and Clinic: An Exploration of Enablers, Impediments and Ethical-Legal Challenges.

Article en Open Acces here.