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Published online before print May 7, 2008, doi:10.1212/01.wnl.0000316436.13659.80)
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NEUROLOGY 2008;71:288-293
© 2008 American Academy of Neurology
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Cell-based interventions for neurologic conditions

Ethical challenges for early human trials

D.J.H. Mathews, PhD, J. Sugarman, MD, H. Bok, PhD, D. M. Blass, MD, J. T. Coyle, MD, P. Duggan, AB, J. Finkel, BA, H. T. Greely, JD, A. Hillis, MD, MA, A. Hoke, MD, PhD, R. Johnson, MD, M. Johnston, MD, J. Kahn, PhD, D. Kerr, MD, PhD, J. Kurtzberg, MD, S. M. Liao, DPhil, J. W. McDonald, MD, PhD, G. McKhann, MD, K. B. Nelson, MD, M. Rao, MD, PhD, A. Regenberg, MBe, A. W. Siegel, JD, PhD, K. Smith, PhD, D. Solter, MD, PhD, H. Song, PhD, A. Vescovi, PhD, W. Young, MD, PhD, J. D. Gearhart, PhD and R. Faden, PhD

From Johns Hopkins University (D.J.H.M., J.S., H.B., D.M.B., P.D., J.F., A. Hillis, A. Hoke, R.J., D.K., S.M.L., G.M., A.R., A.W.S., K.S., H.S., J.D.G., R.F.), Baltimore, MD; Harvard Medical School (J.T.C.), Boston, MA; Stanford University (H.T.G.), CA; Kennedy Krieger Institute (M.J., J.W.M.), Baltimore, MD; University of Minnesota (J.K.), Minneapolis; Duke University Medical Center (J.K.), Durham, NC; National Institutes of Health (K.B.N.), Bethesda, MD; Invitrogen Corporation (M.R.), Carlsbad, CA; Max-Planck Institute of Immunobiology (D.S.), Freiburg, Germany; University of Milan Bicocca (A.V.), Italy; and Rutgers University (W.Y.), Piscataway, NJ.

Address correspondence and reprint requests to Dr. Debra J.H. Mathews, 100 North Charles Street, Suite 740, Baltimore, MD 21201 dmathews{at}jhmi.edu

Background: Attempts to translate basic stem cell research into treatments for neurologic diseases and injury are well under way. With a clinical trial for one such treatment approved and in progress in the United States, and additional proposals under review, we must begin to address the ethical issues raised by such early forays into human clinical trials for cell-based interventions for neurologic conditions.

Methods: An interdisciplinary working group composed of experts in neuroscience, cell biology, bioethics, law, and transplantation, along with leading disease researchers, was convened twice over 2 years to identify and deliberate on the scientific and ethical issues raised by the transition from preclinical to clinical research of cell-based interventions for neurologic conditions.

Results: While the relevant ethical issues are in many respects standard challenges of human subjects research, they are heightened in complexity by the novelty of the science, the focus on the CNS, and the political climate in which the science is proceeding.

Conclusions: Distinctive challenges confronting US scientists, administrators, institutional review boards, stem cell research oversight committees, and others who will need to make decisions about work involving stem cells and their derivatives and evaluate the ethics of early human trials include evaluating the risks, safety, and benefits of these trials, determining and evaluating cell line provenance, and determining inclusion criteria, informed consent, and the ethics of conducting early human trials in the public spotlight. Further study and deliberation by stakeholders is required to move toward professional and institutional policies and practices governing this research.

Abbreviations: CBI-NCs = cell-based interventions for neurologic conditions; ESCROs = embryonic stem cell research oversight committees; FDA = Food and Drug Administration; hESCs = human embryonic stem cells; IND = Investigational New Drug; IRBs = institutional review boards.

e-Pub ahead of print on May 7, 2008, at www.neurology.org.

This project was funded through a grant from the Greenwall Foundation.

Disclosure: The authors report no disclosures.

Received December 21, 2006. Accepted in final form February 8, 2008.






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