Stem-Cell Research in Neurology Continues Despite Lack of Clear Guidelines

Progress in the study of stem cells for neurologic conditions is outpacing ethical oversight in the United States, according to a multiauthored "review-itorial" in last week's online version of Neurology. At least 6 stem-cell products are currently under investigation for neurologic disorders (tabulated below), one of which is in phase 1 development, despite the fact that no review is required at the national level for their study.* Like any other human clinical trial, the study of stem cells is currently relegated to institutional review boards (IRBs) and the FDA, in addition to local embryonic stem-cell research oversight committees (ESCROs).

The authors acknowledge that many of the ethical issues raised by the clinical study of stem cells are similar to those in any clinical endeavor; however, there are ethical challenges which are specific to something as novel as stem-cell clinical trials, particularly when they involve the central nervous system. These include heightened risks related to the development of abnormal brain function, which may be difficult to discern and the timing of which is unclear, and the possible transmission of genetic disease (which is not necessarily peculiar to the stem-cell treatment of neurologic conditions).

*National review of stem-cell study is, for instance, required in the UK by the Human Fertilisation and Embryology Authority.