title: Allowing innovative stem cell-based therapies outside of clinical trials: ethical and policy challenges.
abstract: This paper discusses exceptional circumstances under which patients outside of clinical trials are likely to receive innovative stem cell-based interventions. These circumstances involve: (1) stem cell interventions not initially amenable to a clinical trials approach; (2) expanded access to investigational stem cell products ("compassionate use"); and (3) off-label uses of FDA approved stem cell products. This paper proposes a new approach to regulating these exceptional cases.
authors.affiliation: Department of Bioethics, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
authors.forename: Insoo
authors.initials: I
authors.lastname: Hyun
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D057176:Compassionate Use Trials / Q000941:ethics* / Q000331:legislation & jurisprudence; D004059:Diffusion of Innovation; D026689:Ethical Analysis; D035082:Federal Government; D033161:Government Regulation; D017408:Guidelines as Topic; D006291:Health Policy / Q000331:legislation & jurisprudence; D006297:Health Services Accessibility / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D057193:Medical Tourism / Q000941:ethics / Q000523:psychology / Q000706:statistics & numerical data; D056687:Off-Label Use / Q000941:ethics* / Q000331:legislation & jurisprudence; D044968:Regenerative Medicine / Q000941:ethics / Q000331:legislation & jurisprudence; D033581:Stem Cell Transplantation / Q000941:ethics* / Q000331:legislation & jurisprudence; D057170:Translational Research, Biomedical / Q000941:ethics / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration