Nature Medicine Volume 14 | Number 10 | October 2008

Revamped guidelines aim to keep pace with stem cell advances
By: Stu Hutson, Gainesville, Florida

    This time last year, three scientific papers were nearing the end of their rigorous peerreview process at several of the world’s best known scientific journals, to be published in November. Dozens of the most respected biologists had reviewed them, and editors at the journals had spent fitful nights wondering if they had missed any small detail.
    Simply put, those papers revealed that mere human skin cells could be transmuted into the near-perfect likeness of embryonic stem cells (Cell 131, 861–872; 2007; Science
318, 1917–1920; 2007; Nat. Biotechnol., doi:10.1038/nbt1374; 2007). Only the debunked achievements of the scientist Woo-Suk Hwang had ever loomed as big in the consciousness of the stem cell community.
    Now, less than a year later, the science building on these ‘induced pluripotent stem cells’ (iPS cells) derived from adult tissue is rushing forward at breakneck speed—and the agencies that have taken on the responsibility of regulating this research are trying their best to keep up.
    Experts must reach a consensus before issuing guidelines, and thus drafting such documents can involve an arduous process. Nonetheless, on 5 September, the US National Academies, which include the National Academy of Sciences and the Institute of Medicine, released an amended set of stem cell research guidelines that included an entirely new section for iPS cells. The International Society for Stem Cell Research (ISSCR), meanwhile, has issued a draft version of recommendations on how to move iPS cellbased technology into clinical trials.
    "The stakes are big, and missteps are extremely costly," says Alta Charo, a professor of bioethics at the University of Wisconsinand co-chair of the National Academies’ Human Embryonic Stem Cell Research Advisory Committee. "Anything with the tag ‘stem cell’ is going to be controversial, and we’ve already had a couple of unfortunate incidents that have given people reason to be skeptical."
    Just last month, The Lancet retracted a June 2007 study from an Austrian team that had apparently found a successful stem cell treatment for urinary incontinence (Lancet 369, 2179–2186; 2007). An investigation has reportedly found evidence that the team failed to receive proper ethics approvals for the research and to fully inform the study participants about the known risk of the experimental treatment.
    "These issues occur in every field of research, but when they happen in stem cell science they get so much attention that they do real damage in terms of the support from the public that is absolutely fundamental to keep this research going," says Geoff Lomax, the senior officer for medical and ethical standards at the California Institute for Regenerative Medicine (CIRM).
The best protection is for well updated guidelines to be in place and for agencies to follow them, he said. This is especially true for iPS cells.    Nat Med. 2008 Oct;14(10):993.

READ THE ENTIRE ARTICLE AT NATURE MEDICINE ONLINE