WIKIMEDIA, RYDDRAGYNMany 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 today (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.
“The main concern is: How do we move this technology [to the clinic]? How do we translate it?” said Erica Jonlin, the author of the report and the regulatory manager at the University of Washington Institute for Stem Cell and Regenerative Medicine.
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.
Some of the lines clearly state that they are not to be developed for therapies, but for the others that don’t have such restrictions, the point might be moot. That’s ...
