Journal of the National Cancer Institute Advance Access originally published online on November 13, 2007
JNCI Journal of the National Cancer Institute 2007 99(22):1666-1667; doi:10.1093/jnci/djm241
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© Oxford University Press 2007.
NEWS |
Researchers Hope State Stem Cell Efforts Last
Several states are moving forward with efforts to fund studies involving human embryonic stem cells. Even though most of these programs are still in the embryonic stages themselves, they may prove to have an enduring effect on the field.
In August 2001, President Bush signed an executive order limiting the use of federal funds for research involving human embryonic stem cells to lines that were already established at the time. Even if the current federal policy were overturned, a law passed in 1995 already barred federally funded scientists from any work that destroys a human embryo, which is required to create a new cell line with current technology.
At least partly because of these federal policies, New Jersey became the first state to approve its own funding for embryonic stem cell research in 2004 and has appropriated $23 million for grants so far. Since then, California, Connecticut, Illinois, Maryland, Massachusetts, and New York have established funds for stem cell research or are working toward doing so (see box). Lawmakers in Florida and Washington are also debating whether to launch stem cell funding initiatives. Meanwhile, private foundations and other philanthropic entities are moving to support the work of individual institutions and researchers, albeit to a lesser extent.
| A State By State Look at Stem Cell Funding California: Voters have approved a $3 billion funding effort. Connecticut: The legislature passed a bill to provide $10 million a year for 10 years. Maryland: The state has put up $15 million this year. New York: Lawmakers recently established the Empire State Stem Cell Trust Fund with $100 million, plus the promise of $50 million annually over the next 10 years. Illinois: The governor established a stem cell institute, which lawmakers later formalized. Massachusetts: The legislature passed a funding measure.
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The California effort, which is by far the biggest and boldest so far, is also one of the farthest along. Now entering its second round of funding, the state plan has had to follow a bumpy road to get as far as it has.
The California Institute for Regenerative Medicine, the entity established to dole out the state's research dollars, has only recently been able to issue its first bonds, after several years of lawsuits challenging the state's authority to operate the program. Although the courts eventually rejected those arguments, the lawsuits delayed the issuing of any bonds to fund the institute, which was initially financed and made grants only with the help of private donations.
Other states have faced similar hurdles, such as Massachusetts, where the legislature eventually overrode the governor's veto, and Florida, where competing constitutional amendments—one to fund stem cell research and one to ban such funding—go before the electorate next year.
Private Donations Fill Gap
While states struggle to start these programs, private donors have been working to fund stem cell research without federal support. In California and other states, large contributions have enabled universities to set up new laboratories where they can conduct work on human embryonic stem cells separately from their federally funded work. Foundations are also funding research fellows and projects. The New York Stem Cell Foundation, the only charitable foundation dedicated solely to this area of research, supports seven research fellows with 3-year grants and a privately funded laboratory. The foundation also conducts outreach and public education activities.
"A private initiative has always been the stimulus for keeping people on track, keeping them focused, keeping a sense of urgency," said Susan Solomon, J.D., the foundation's chief executive officer and cofounder.
Ultimately that is the aim, but the foundation faces a much more basic task: encouraging new researchers to enter the field. "One area where, unfortunately, the federal policy has been incredibly successful is in discouraging people from going into the field in the first place, because it is just an enormous hassle."
Once states get their funding efforts going, that effect is one of the first obstacles that they must confront as well. The California Institute for Regenerative Medicine's first round of funding consisted of 169 fellowships at 16 institutions to train a variety of people in the basics of stem cell research. That step was followed by seed grants and new-faculty awards that span 5 years.
"During the strategic planning process, there was a lot of emphasis on the need for people to have stability in the field and not be living hand to mouth. That's reflected in the grants program. To the extent that there is a chilling effect, certainly that was identified as a problem. We’ve tried to let some sunshine in, and [we hope] there is a big thaw going on here on the West Coast," said Geoffrey Lomax, D.P.H., a senior officer for the California Institute for Regenerative Medicine's standards working group, which oversees the implementation of the state statute that established the institute.
In what may be evidence of that thaw, nearly 50 stem cell scientists have moved to California, including some international researchers, since the state funding was established.
Despite support for these efforts within the community, there are still some lingering concerns over states’ ability to fulfill what has traditionally been a federal role in funding and supervising medical research. "Do they have the bandwidth and expertise to oversee patient advocacy, scientific excellence? Only time will tell. They certainly don’t have it built in," the New York Stem Cell Foundation's Solomon said.
Compared with overall National Institutes of Health funding, these state programs may seem small, but NIH itself is spending less than $40 million a year on this type of research. So the $300 million a year in California alone looks like a lot of money to researchers in this field, especially because it is concentrated in one state. The individual grants are of a similar size and, at least in California, they are more readily available than NIH grants.
Several states that have funding efforts have jointly established ethical and operational standards that will allow their scientists to share information and pool resources, but they still face important obstacles in replicating the infrastructure that already exists for federally funded research, Lomax said.
Although states may not have the full resources available through the federal government, NIH provides a good model for states to follow.
"When we developed our rules, we really had a close eye on the existing infrastructure. We certainly did not want to replicate or otherwise reinvent what was already going on. There is plenty of structure already there," he said.
The Haves and Have Nots
For researchers, those are details for the bureaucrats to work out. That there is now or soon will be funding is enough, said Jerome Zack, Ph.D., a stem cell researcher at the University of California, Los Angeles.
"It's still a little early because the funds are just beginning to become available, but it certainly has galvanized a lot of excitement, here at UCLA and other institutions in the state. People are interacting, collaborating, directing their research more toward stem cell–based stuff, expanding work that might have been a lower priority if there were no state funding. It really has made a difference in terms of the enthusiasm for work in this area," he said.
Charles Limoli, Ph.D., an associate professor of radiation oncology at the University of California, Irvine, agreed. "They have $300 million a year exclusively for California scientists. No one else in the United States can compete for these funds. ... I feel lucky that I don’t have to compete with scientists from the 49 other states for this money."
Limoli is studying the ability of certain stem cells to repopulate regions of the brain that are damaged by radiotherapy. However, because these cells are multipotent, they may also be prone to mutations and potentially cancer-causing themselves.
"We have a lot of evidence suggesting that these neural precursor cells, under the right conditions, after certain stresses, may actually form cancer. The reason that stem cell researchers are concerned about this, or should be concerned about this, is that we really don’t know, if we go in and start using human embryonic stem cells in people, what are the cancer risks."
The California Institute for Regenerative Medicine is funding a preliminary study by Limoli to test whether human embryonic stem cells form tumors when implanted. He is also hoping to get another state grant to explore the therapeutic potential of stem cells for people undergoing radiation therapy.
For researchers like Limoli, the main drawback of state funding seems to be the hassle involved in convincing university officials that no federal rules are being broken. "In a practical sense, what that translates to for me is 10 different forms that are 10 pages long that I have to fill out for no apparent reason," Limoli said—although he noted that the extra paperwork is much less an imposition than not having the money at all.
Researchers in states that aren’t funding stem cell research are only too aware of that fact. It's a good news–bad news situation, said Dan Kaufman, M.D., Ph.D., an assistant professor at the University of Minnesota's Stem Cell Institute. While having NIH funds available to study approved stem cell lines is helpful, he worries that the lack of funds to derive or work with new cell lines will hinder his ability to build on his current research, which involves deriving lymphocytes, infection-fighting white blood cells, from human embryonic cell lines. These derived lymphocytes display potent antitumor activity, much stronger than that of lymphocytes derived from adult or cord blood stem cells.
"The stage where my research is, as with a lot of research at the basic level, using the federally approved cell lines is fine. They are well characterized, they suit our purposes, and we are able to get NIH funding," he said. However, the prohibition has stymied other projects of his, such as research on the link between the genetic disorder Fanconi anemia and leukemia.
"What we are interested in is obtaining those embryos that are affected by the FA mutation and deriving new [embryonic stem cell] lines from those. Those could be very useful in the lab, where we now have a lot of experience studying blood cell development to understand how this FA mutation causes leukemia or genetic instability in a real human model," he explained.
While the University of Minnesota maintains a modest facility for working with stem cell lines that don’t qualify under the federal rules, that falls far short of the resources that would be available to similar research funded through NIH.
"There are private foundations, so we have a small amount of funds for this type of work ... but mostly we just don’t do the research," Kaufman said.
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