Stem-cell case rattles state’s researchers

Connecticut stem cell researchers waited for answers and contemplated potential damage to their field Tuesday, a day after a federal court ruling that could limit funding for embryonic stem cell research.

“I don’t think anybody completely understands what it’s going to mean,” said Laura Grabel, a Wesleyan University professor whose research involves embryonic stem cells.

On Monday, U.S. District Judge Royce C. Lamberth issued a preliminary injunction in Washington, D.C., prohibiting the use of federal funds for research involving human embryonic stem cells.

Plaintiffs in the case had sought to block National Institutes of Health guidelines that allow funding of human embryonic stem cell research. In his ruling, Lamberth found that the plaintiffs were likely to prevail in their claim that the guidelines violate a federal law prohibiting the use of federal funds for research in which human embryos are destroyed.

Lamberth wrote that the injunction would “simply preserve the status quo,” but stem cell researchers said they were waiting for guidance from the U.S. Department of Justice and NIH to understand what that would mean.

Laura Grabel

Laura Grabel (Wesleyan University)

The possibilities, researchers said, include the federal government being barred from funding research involving new stem cell lines, but continuing to fund existing work.

Or it could mean a return to Bush administration policies, when federal funding was limited to research involving a small number of embryonic stem cell lines. Or, some said, it could produce an even stricter prohibition, stopping federal funding of all work involving embryonic stem cells, even those allowed under Bush.

“This could be a huge setback for the work, huge,” Grabel said.

Whatever the result, it could have significant implications for researchers in Connecticut, where stem cell research has been a burgeoning field since state leaders in 2005 committed $100 million to fund the work over 10 years.

The money helped universities to build stem cell laboratories and lure top researchers, and funded Connecticut scientists pursuing research into conditions including Parkinson’s disease, osteoarthritis and epilepsy, at a time when federal funds were limited.

For Connecticut scientists with federal grants, Monday’s ruling could require changes. Marc Lalande, director of UConn’s Stem Cell Institute, said some researchers might need to be moved to facilities that do not receive federal funding, or might need to rework their research to use different stem cell lines.

“I think we’re going to have to retool,” Lalande said. “Stopping is not an option.”

Changing Rules

Lamberth’s ruling hinged on a 1996 law, the Dickey-Wicker Amendment, which prohibited the use of federal funds for the creation of human embryos for research or for research in which human embryos are destroyed.

Since 1999, the U.S. Department of Health and Human Services has recognized a distinction between deriving stem cells from an embryo, which destroys the embryo, and research using embryonic stem cells, which does not lead to the destruction of an embryo, Lamberth wrote in his ruling.

Federal policy changed during the Bush and Obama administrations, but in both cases, federal funds were allowed to support some embryonic stem cell research.

In 2001, President Bush prohibited federal money from funding research on human embryonic stem cell lines created after his order. But he allowed federal funds to support research using embryonic stem cells that had already been created.

Last year, President Obama issued an executive order allowing NIH to support and conduct “responsible, scientifically worthy” human stem cell research, and directed NIH to issue new guidelines for the research. NIH published the guidelines last July.

The plaintiffs in the case, James L. Sherley and Theresa Deisher, argued that the guidelines violated the Dickey-Wicker Amendment. Sherley and Deisher are researchers who work with adult stem cells, and they argued that federal funding for embryonic stem cells would harm them by increasing competition for limited funds.

In ruling that the plaintiffs’ case was likely to succeed, Lamberth rejected the idea that research on embryonic stem cells should be considered separate from the act of deriving embryonic stem cells. He wrote that embryonic stem cell research relies on the destruction of a human embryo since it requires stem cells that are derived in a process that destroys the embryo.

“If one step or ‘piece of research’ of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker Amendment,” Lamberth wrote. “Because ESC research requires the derivation of ESCs, ESC research is research in which an embryo is destroyed.”

Changing Lines, Labs

At UConn, researchers have several federal grants for work using human embryonic stem cells. Until the federal government issues guidance, Lalande said he expected UConn would “assume, for the time being, the worst case scenario.”

Marc Lalande

Marc Lalande (UConn Health Center)

If some embryonic stem cell lines are still allowed, Lalande said researchers could switch their work to those lines. Scientists working without federal money could move to a facility that does not have any federal funding.

The university will follow the guidelines, and will not stop the research, he said.

“No matter what, there would be a setback,” he said. “We’re completely well-equipped and organized to change some experimental protocols if we need to, but there will be for some investigators a loss of time and effort.”

The ruling will not affect research conducted without federal funding, although many scientists have considered NIH as a future source of funding, and some are working on grant applications.

At Yale University, which has invested millions of dollars in stem cell research, officials are waiting for an interpretation from NIH about what Lamberth’s ruling means for grant funding, a spokesman said.

Ren-He Xu, director of the UConn Stem Cell Core, said the ruling underscores the importance of state funding for stem cell research, something that scientists fear could be in jeopardy as the state faces massive budget problems. Last year, Gov. M. Jodi Rell proposed redirecting $10 million to the general fund rather than stem cell research, although ultimately the money went to research.

In a statement Tuesday, U.S. Rep. Chris Murphy, D-5th District, who was involved in creating the state stem cell funding program, called for a “common-sense, bipartisan stem cell research bill” to provide long-term financial support.

“The debate over stem cell research should be over — it is the biggest medical advancement in decades, and it should be practiced in a responsible manner to save lives,” he said.

Embryonic stem cells carry the potential to develop into many types of cells, and scientists believe they could be used to help understand and treat a wide range of diseases and conditions.

Ren-He Xu

Ren-He Xu (UConn Health Center)

In recent years, scientists have also worked with another type of stem cells, called induced pluripotent stem cells, or iPSCs, that do not require cells from embryos. Instead, they are made from adult stem cells that have been genetically modified to take on properties of embryonic stem cells. But Xu and Grabel said iPSCs are not suitable as a complete replacement because they do not work exactly like embryonic stem cells and the methods used to create them can cause problems.

Grabel’s research is now funded by state grants. She had a federal grant that ran out last summer, and had plans to apply for more federal funding. On Tuesday morning, she was contemplating what to do about the application.

“When we’re trying to move forward and be competitive, these two steps backwards are just not a good thing,” she said.

When the Bush administration restrictions were in place, researchers were careful to keep equipment and work funded with federal money separate from those used for embryonic stem cell research. At UConn, blue and red tags labeled equipment, marking what could and could not be used for work involving federal money.

Grabel remembered her colleagues at UConn celebrating when the Bush administration restrictions were lifted, when the tags could come off the equipment.

“I hope people didn’t throw the tags away,” she said.