Medicine on the fringe: stem cell-based interventions in advance of evidence.
Stem cell-based interventions (SCBIs) offer great promise; however, there is currently little internationally accepted, scientific evidence supporting the clinical use of SCBIs. The consensus within the scientific community is that a number of hurdles still need to be cleared. Despite this, SCBIs are currently being offered to patients. This article provides a content analysis of materials obtained from SCBI providers. We find content that strains credulity and almost no evidence of SCBIs being delivered in the context of clinical trials. We conclude that until scientific evidence is available, as a general rule, providers should only offer SCBIs in the context of controlled clinical trials. Clients should be aware that the risks and benefits of SCBIs are unknown, that their participation is unlikely to advance scientific knowledge, and they are likely to become ineligible to participate in future clinical trials of SCBIs. We recommend steps to promote patient education and enhance global oversight.
Regenberg
Alan C
AC
Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland 21201, USA.
Hutchinson
Lauren A
LA
Schanker
Benjamin
B
Mathews
Debra J H
DJ
D015510:Clinical Medicine / Q000191:economics* / Q000379:methods* / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic; D026690:Ethics, Clinical; D006801:Humans; D033581:Stem Cell Transplantation / Q000191:economics / Q000941:ethics / Q000706:statistics & numerical data*; D016896:Treatment Outcome