BioEd Online

Scientists and research advocates worldwide are celebrating the removal of rules limiting research on human embryonic stem cells in the United States, which they say have restricted the field's progress for seven and a half years.

The National Institutes of Health (NIH) in Bethesda, Maryland, is now working out policies that will allow researchers to apply for grant money from the agency to study some of the hundreds of cell lines created since 9 August 2001, when President George W. Bush limited federal funding to research on lines in existence at that time. Some scientists are already proposing to use the new lines in applications for $200 million in NIH 'Challenge' grants, which will be funded by the economic stimulus package signed into law last month. Details of these grants were unveiled last week (see NIH website).

Estimates of the number of new lines range from 400 to 1,000. Unlike the 21 lines previously eligible for federal funding, many of the lines have been made from embryos that had genetic predispositions to specific diseases, or were derived using 'animal-free' preparations, and thus could be more relevant to laboratory research and preclinical studies.

President Barack Obama signed the executive order on 9 March at a White House ceremony attended by scientists, lawmakers, patients and patient advocates. "We will vigorously support scientists who pursue this research," Obama said. "And we will aim for America to lead the world in the discoveries it one day may yield."

The new order asks the NIH to develop guidelines and regulations within 120 days to govern federally funded human embryonic stem-cell research. Work is already under way at the NIH to develop guidelines covering the eligibility of cell lines for federal funding. These will be based on issues such as the kind of informed consent given by couples who donated the leftover embryos from which the cells were collected. Such cells can develop into any type of tissue in the body, and are thus thought to hold enormous promise as tools for dissecting disease processes, screening possible treatments and developing new therapies.

Legislation to codify the change has already been introduced into both the House of Representatives and the Senate. It explicitly permits federal funding for research on stem-cell lines derived with parental permission from embryos left over at fertility clinics and other­wise slated for destruction. At least one observer has suggested that legislation expli­citly approving federal funding for stem-cell research is needed to address the Dickey–Wicker amendment, a law first enacted by Congress in 1996 and renewed every year since, that prohibits federal funding of research in which embryos are created or destroyed (see _Nature_ 457, 1068–1069; 2009).

Scientists and advocates say the change will speed up research on stem cells and the development of possible treatments around the world, and will help remedy what they see as the Bush administration's legacy of political interference in science. "This is the first time that the key decisions and guidelines on this issue are going to be made in Bethesda and not at 1600 Pennsylvania Avenue," says Larry Soler, executive vice-president of the Juvenile Dia­betes Research Foundation International, based in New York City. "That is what the scientific community and the patient community have been asking for."

But there was a bittersweet taste to the victory, as scientists lamented almost a decade of delays to the research. "There's no doubt that this federal policy has really slowed the rate of progress of stem-cell research in the United States, and the impact of the change in policy would have been greater if it had happened years ago," says Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at the University of California, San Francisco.

Those who oppose the research because it involves the destruction of embryos criticized Obama's decision. They say that the NIH should support research only on cells that are not derived from embryos, such as induced pluripotent stem cells (iPS cells), which are derived from adult cells but have many properties of embryonic stem cells.

But iPS cells, first created in 2006, are not a substitute for embryonic stem cells, Kriegstein says. "iPS technology and its ongoing improvement will likely eclipse embryonic stem-cell lines for diagnostic and therapeutic applications, but for now, embryonic stem cells are clearly needed. And it's still not clear how iPS cells will ultimately compare for therapeutic purposes."

Obama's action will begin to level the playing field for researchers in the United States, where some states — most notably California, which created the $3-billion California Institute for Regenerative Medicine (CIRM) in 2004 — have leapfrogged ahead of others by funding stem-cell research themselves. And it will have ripple effects around the world, some predict. "This type of science is international, and the whole world has suffered from the previous short-sighted and rather bizarre policy," says Robin Lovell-Badge of the National Institute for Medical Research in London.

For instance, Lovell-Badge collaborates on one project with NIH-funded scientists who have had to limit their work to the previously approved cell lines. More broadly, the lack of policy guidance from the NIH — normally a global science-policy leader — "has contributed to the morass of different rules adopted around the world, which in turn inhibits collaboration, goodwill and progress", Lovell-Badge adds.

Indeed, CIRM president Alan Trounson says that other nations with restrictive stem-cell research policies, such as Germany, now seem to be rethinking their stance, and he predicts that the Obama administration's support for the research will accelerate this trend. Such support may also encourage wary investors and pharmaceutical companies to become more involved in funding the research, and this could benefit both the biotechnology industry and the development of new treatments.

"Since Obama was elected, the pharmaceutical industry is clearly much more interested in stem cells," Trounson says. "That will be a really big help when we're working through costly and difficult clinical trials to get treatments to patients."