Embryonic stem-cell research by Stanford University researchers could be terminated under a preliminary U.S. District Court ruling -- even if stem cells are involved in only part of the research.
Chief Judge Royce C. Lamberth issued a preliminary injunction Aug. 23 suspending federal funding for human embryonic stem cell research.
Lamberth ruled that experiments with stem cells fall under a 1996 law prohibiting federal funding of research that will destroy human embryos.
The ruling is "profound and disturbing," according to Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine.
The long-term impact of the ruling, should it become permanent, would be "a massive halt to most embryonic stem cell research in the United States," Weissman warned.
Research using adult stem cells would not be affected under the ruling.
Stanford researcher Joanna Wysocka said her work on treating a rare developmental disorder in children could be endangered by the ruling.
Her work is primarily focused on CHARGE syndrome, a congenital disorder that affects one in 10,000 children and has potentially life-threatening complications.
Her initial work on the syndrome's mechanism was published in the science journal Nature, and she received the 2010 Outstanding Young Investigator Award from the International Society for Stem Cell Research.
The injunction puts in doubt National Institutes of Health (NIH) funding she was hoping to receive, she said. NIH rated her proposed project as more worthy than 99 percent of the proposals received, Wysocka said. She is an assistant professor of chemical and systems biology and of developmental biology.
"With my new-investigator status and the grant proposal score, I was confident that the application would be funded," she said.
Her initial work was funded by a seed grant from the California Institute for Regenerative Medicine, but that grant has ended.
"I am currently funding this project largely from leftovers of my start-up funds and relatively unrestricted junior investigator awards, but we need more money to continue," she said.
The uncertainty surrounding her research is being duplicated around the country, in part due to the ambiguous nature of the Lamberth ruling, according to according to officials at Stanford Law School.
The legal decision focuses on the challenge to the Obama administration guidelines, which have been in force since March 2009. Those guidelines replaced the Bush administration guidelines, which restricted research to a limited number of human embryonic stem cell lines.
Lamberth's injunction rejects the Obama administration guidelines. The judge's reasoning -- that any human embryonic stem cell research necessarily requires the destruction of human embryos and therefore contravenes existing law -- also seems to make it illegal to use federal funding even for research on cell lines that were approved by the Bush administration, law school officials said.
The order stops the NIH from implementing not only the Obama guidelines but may mean that all human embryonic stem cell research is ineligible for federal funding, according to Hank Greely, director of the Stanford Center for Law and the Biosciences.
"I'm sure the Department of Justice and the NIH are trying to figure this all out," Greely said.
For now, NIH officials have said that researchers at universities who had already received funding for human embryonic stem cell work could continue their projects.
But the agency is freezing its consideration of new research proposals involving embryonic stem cells. The NIH told researchers Aug. 30 on the NIH campus to halt all human embryonic stem cell research.
With the nation's legal experts still struggling to determine the implications of the ruling, physicians and medical researchers are feeling pressure to take a conservative course. Some Stanford researchers are taking a second look at their plans to start research involving stem cells derived from embryos.
Radiology professor Brian Rutt, who joined Stanford last year, is in the initial stages of creating advanced imaging methods for stem cells, but now questions that course of inquiry.
"This is a fairly new effort of mine, and I wouldn't want to change my focus too quickly from conventional imaging research toward stem-cell-specific imaging if the prospects for future NIH funding are dim," Rutt said.
Wysocka is most concerned about the immediate future. Only one-third of her NIH research grant proposal is focused on human embryonic stem cells, but that could jeopardize the rest of her funding, she said.
Most of the proposed research involves frog embryos and stem cells on which there are no federal funding restrictions. But as it stands, a "mixed" grant with even a small amount of human embryonic stem cell research might not be funded and the ruling may affect the non-stem-cell aspects of her grant, she said.