By TRACEY DRURY
tdrury@bizjournals.com | 716-541-1609

A judge's order ending federal funding to research using embryonic stem cells could have a $4 million negative impact at the University at Buffalo.

Though the order won't yet put a halt to research under way in the Buffalo area, local researchers and policymakers at the local and state levels say the ruling could ultimately have a chilling effect on all research that involves stem cells - with an impact on promising work in the fields of Parkinson's disease, heart disease and even cancer.

The ruling by U.S. District Judge Royce Lamberth, issued Aug. 23, temporarily halts the Obama administration from using federal dollars to expand stem cell research that destroys human embryos. Research groups across the country have attacked the ruling, saying it will affect ongoing research begun using previously created embryonic stem cell lines OK'd under the Bush administration.

Both administration policies responded to the 1996 Dickey-Wicker Amendment, which restricted federal funds for research that could destroy or damage human embryos. The Bush policy allowed research using a small number of cell lines already established, which was expanded by Obama last year. Two researchers challenged the Obama expansion last year, which led to the federal judge's injunction in late August.

Researchers say even if the majority of their work does not rely on embryonic stem cells, they still rely on previously established baselines from which to gauge their progress.

That's the case for Jian Feng, a UB professor of physiology and biophysics. He is working to find a treatment for Parkinson's disease with a $1 million grant from the New York State Stem Cell Science initiative and two federal grants that bring in more than $300,000 annually from the National Institutes of Health.

"We do not need to use human embryonic stem cells directly, but it remains the gold standard in producing these cells," he says. "If they cut out the funding, it's like setting a boat on the sea without a compass."

Feng's work is among 15 projects under way at UB that collectively receive about $15.2 million in funding, including more than $4 million in federal funding from NIH and the National Science Foundation. The work covers research into cardiovascular disease, neurological diseases, pulmonary diseases, cancer, diabetes and other chronic diseases.

Additionally, several applications are pending with various funding agencies, some of which could be affected by the judge's ruling, says Alexander Cartwright, UB's interim vice president for research.

Though more than $11 million of the work under way is funded by the state stem cell program, which is not affected by the federal ruling, scientists are definitely nervous, he says.

The majority of work under way at UB uses adult stem cells. However, a number of federal applications were submitted or were about to be submitted that call for using embryonic stem cells and now are on hold.

"I think what they're really concerned about is where does it stop? We may be okay right now; in another year we may be in jeopardy," Cartwright says. "So I think you will find by talking to the stem cell researchers there's a lot of nervous people right now. We just don't know what's really going to happen."

A statement from the International Society for Stem Cell Research called the court decision unfortunate, as it threatens to impede the progress of regenerative medicine in this country and the potential to create treatments for devastating human diseases for which there are presently no cures.

Members of NYSTEM's board of directors say the state will continue to follow guidelines of the international society, as well as the National Academies for Science, in continuing to provide funding for stem cell research.

Judy Doesschate, an attorney and director of NYSTEM board operations, says the board has debated these same issues for years in developing its own guidelines. No specific additional statement has been issued since the new federal order, she says.

"I don't see them as feeling the need to comply with or be consistent with the federal judge's ruling," she says.

Since its inception, the New York State Stem Cell Science program has awarded $303 million from the Empire State Stem Cell Trust Fund. Dr. David Hohn, a founder and vice chairman of the NYSTEM board, says though the majority of research taking place locally does not use embryonic stem cells in a major way, researchers do sometimes use embryonic stem cells for comparison when determining if a stem cell has pluropotency, or the ability to develop into more than one cell.

"You need some kind of a benchmark, and one of the benchmarks is using an embryonic stem cell line derived for research purposes," says Hohn, who also serves as president emeritus and executive director of health policy at Roswell Park Cancer Institute.

"This is a very promising field that could easily become more promising over time," he says, pointing to the first two clinical trials under way that involve human stem cells. "Many scientists are concerned about the long-term implications of this, even if they're not using federal embryonic lines at this point."

But researchers are still concerned. Richard Gronostajski, a biochemistry professor in the UB School of Medicine and Biomedical Sciences, is heading up a project to create a stem cell research center at UB with a $3.5 million grant from NYSTEM. He's also conducting stem cell research of his own, using primarily adult stem cells in mice to study the creation of neurons in the brain.

One of the requirements for Gronostajski in developing a stem cell research center is that he must abide by all state and federal regulations. In theory, he says, that could affect the state-funded research, as well.

And though he recognizes that the moratorium is strictly on federal funds and will not affect the NYSTEM funding, Gronostajski says further interpretation of the ruling could be devastating. That's because scientifically, all stem cells are originally derived from embryos. Taking that argument to its logical conclusion would mean researchers would have to stop using every human cell line, used in research for everything.

"If they've banned work on all human embryonic stem cells, as the reports I saw said, then it does have ramifications for all research on human stem cells, which would be frightening," says Gronostajski.

Ron Leuty of the San Francisco Business Times also contributed to this article.