Many of the stem cell lines used by academics and registered with the U.S. National Institutes of Health (NIH) would not be eligible for commercialization because they don’t pass muster with the Food and Drug Administration (FDA), according to a report published February 6 in Cell Stem Cell. The lack of harmonization between the agencies’ standards throws up a potential roadblack on the path from the laboratory to the clinic.
As of today, the NIH registry contains 261 stem cell lines eligible for federal research funding. As Jonlin pointed out in her report, each line had to pass ethical standards—namely, that the embryo donors consented for their use in research and that the embryos were created for the sole purpose of fertility treatment.
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