Safety issues in cell-based intervention trials.
We report on the deliberations of an interdisciplinary group of experts in science, law, and philosophy who convened to discuss novel ethical and policy challenges in stem cell research. In this report we discuss the ethical and policy implications of safety concerns in the transition from basic laboratory research to clinical applications of cell-based therapies derived from stem cells. Although many features of this transition from lab to clinic are common to other therapies, three aspects of stem cell biology pose unique challenges. First, tension regarding the use of human embryos may complicate the scientific development of safe and effective cell lines. Second, because human stem cells were not developed in the laboratory until 1998, few safety questions relating to human applications have been addressed in animal research. Third, preclinical and clinical testing of biologic agents, particularly those as inherently complex as mammalian cells, present formidable challenges, such as the need to develop suitable standardized assays and the difficulty of selecting appropriate patient populations for early phase trials. We recommend that scientists, policy makers, and the public discuss these issues responsibly, and further, that a national advisory committee to oversee human trials of cell therapies be established.
Dawson
Liza
L
Phoebe R Berman Bioethics Institute, Johns Hopkins University, Baltimore, Maryland 21205, USA. rfaden@jhsph.edu
Bateman-House
Alison S
AS
Mueller Agnew
Dawn
D
Bok
Hilary
H
Brock
Dan W
DW
Chakravarti
Aravinda
A
Greene
Mark
M
King
Patricia A
PA
O'Brien
Stephen J
SJ
Sachs
David H
DH
Schill
Kathryn E
KE
Siegel
Andrew
A
Solter
Davor
D
Suter
Sonia M
SM
Verfaillie
Catherine M
CM
Walters
LeRoy B
LB
Gearhart
John D
JD
Faden
Ruth R
RR
D000818:Animals; D035843:Biomedical Research / Q000941:ethics*; D002460:Cell Line; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D020022:Genetic Predisposition to Disease; D006801:Humans; D017053:Infection Control; D011786:Quality Control; D013234:Stem Cells