The National Institutes of Health (NIH) announced today that 13 new embryonic stem cell lines are now eligible for federal funding. That means that scientists with NIH grants can study embryonic stem cells derived using newer, more refined methods generally considered to be superior to the older ones. Ninety-six additional lines are also now under review.

"Those were early days in the science of stem cell research, and much has been learned since then," said NIH director Francis Collins in a press conference on Wednesday, referring to the stem cell lines, created before 2001, that had previously been eligible for federal funding. "In the last eight years, hundreds of embryonic stem cell lines have been derived using non-federal funds, many of them carrying more favorable characteristics."

As I wrote in a previous story:

Using only the old lines is like "being required to use Microsoft Word 1998," says Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute, in La Jolla, CA.

The earlier lines were derived using animal products, making them largely unfit for therapeutic use. "There are hundreds of embryonic stem-cell lines out there that have been made under the best conditions, and some of them are patient ready," says John Gearhart, director of the Institute for Regenerative Medicine at the University of Pennsylvania, in Philadelphia. "They have greater utility, performance, and safety than [the Bush-approved] lines."

The announcement follows President Obama's executive order made last March, enabling government support for embryonic stem cell research. That order overturned a previous one by President Bush in 2001, limiting federally-funded research to a set of existing cell lines. The 2001 decree forced scientists who wanted to create and use new stem cell lines, derived from leftover IVF embryos, to garner private funding.

Eleven of the 13 new lines were generated in George Daley's lab at Children's Hospital, in Boston, which used private funding to make them. According to the New York Times, "Dr. Daley said that private financing had been drying up and that he was eager to start research on the now-approved cell lines with the help of his federal grant money." Researchers still cannot derive new lines using federal funds--creating new lines requires the destruction of an embryo.

President Obama has finally indicated that he will make good on his campaign promise to end federal funding restrictions on embryonic stem cell research. The restrictions, put in place by George W. Bush in 2001, specifically limited federal funding for embryonic stem-cell research to a small number of cell lines already in existence, leaving scientists who wanted to conduct cutting-edge research in this area scrambling for private money.

According to an article from Reuters:

President Barack Obama, who opposes limits on federal funding of stem cell research, will sign an executive order related to the issue on Monday, an administration official said on Friday.

The official could not confirm the details of what Obama would sign, but advisers had previously said he favored lifting the eight-year limitation on funding of human embryonic stem cell research imposed by his predecessor, President George W. Bush.

The official also said Obama would make an announcement about a broader initiative to restore scientific integrity to government processes.

A piece I wrote in February on the expected reversal outlines the potential benefits for researchers:

Once the restriction is lifted, labs funded by federal dollars will be allowed to use most of the estimated 600 stem-cell lines that have been created around the globe. Researchers broadly agree that the newer lines, which were derived using more refined methods, are superior to the older ones. Using only the old lines is like "being required to use Microsoft Word 1998," says Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute, in La Jolla, CA.

In addition, the earlier lines were derived using animal products, making them largely unfit for therapeutic use. "There are hundreds of embryonic stem-cell lines out there that have been made under the best conditions, and some of them are patient ready," says John Gearhart, director of the Institute for Regenerative Medicine at the University of Pennsylvania, in Philadelphia. "They have greater utility, performance, and safety than [the Bush-approved] lines."

Scientists will also be able to study cell lines that are genetically encoded for specific diseases--perhaps one of the most promising near-term uses of embryonic stem cells. (None of the Bush-approved lines have these qualities.) "One of the clear opportunities that has not been available are lines generated from embryos that carry mutations for Huntington's disease, amyotrophic lateral sclerosis (ALS), and cystic fibrosis," says Story Landis, director of the National Institute for Neurological Disorders and Stroke, in Bethesda, MD, and chair of the NIH's Stem Cell Task Force. These cells provide unprecedented access to the molecular processes underlying disease; they can be prodded to develop into the cell type affected in a specific disease, such as motor neurons in ALS, so that scientists can watch the disease unfold at a cellular level. These cells can also be used to screen new drugs.

This micrograph shows a colony of undifferentiated human embyonic stem cells. Credit: Argonne National Laboratory

Nearly 20 companies across the globe are peddling dubious stem cell therapies directly to consumers, according to a study published today in the journal Cell Stem Cell. These companies, offering treatments for disorders ranging from autism and Parkinson's disease to spinal cord injury and heart disease, provide little proof that their therapies are truly stem cells, and little experimental evidence exists in the scientific literature to back their claims. The treatments are expensive--Timothy Caulfield of the University of Alberta in Canada and his colleagues found that the average price was about $21,500 among the sites listing price.

In the same journal, the International Society for Stem Cell Research issued a set of guidelines to ensure responsible research. According to a statement from the society, "These guidelines define a roadmap for medical researchers and doctors, outlining what needs to be accomplished to move stem cells from promising research to proven treatments for patients."

According to an article from HealthDay:

"Stem cell research is progressing so rapidly and has sparked a lot of interest in translational research [including] among patients in hopes for therapies," said Insoo Hyun, lead author of the paper outlining the guidelines and an associate professor of bioethics at Case Western Reserve University School of Medicine in Cleveland.

"At the same time," he said, "legitimate science is speeding ahead and getting to the point where there needed to be more of a road map to take the basic knowledge to clinical applications."

...

Different clinics in China (Beike Biotech), the Ukraine (ACT) and elsewhere claim to have treated thousands of patients for neurological disorders including multiple sclerosis, Parkinson's disease, spinal cord injury and Alzheimer's disease, congenital conditions such as autism and cerebral palsy, as well as allergies, heart conditions and even cosmetic procedures. However, the University of Alberta team was unable to find any studies that had even investigated stem cell therapy for Parkinson's disease or for Alzheimer's, for example.

Nowhere, apparently, was there any authentication of whether the stem cells actually were stem cells, or where they had come from.

...

"Most of the time, stem cell products are presenting entirely novel products that are unpredictable in humans," Hyun said. "Unlike drugs, you can't just create a batch and put them on the shelf and expect they will be the same. We need uniform quality control and manufacturing. And if they're embryonic or pluripotent stem cells, they could form unwanted tissues or tumors. So, we have to be very careful about following up and monitoring patients."

A 2005 feature in Technology Review, "The Problematical Dr. Huang Hongyun", examined the practices of a Chinese physician offering cell therapy for spinal cord injury.

It's not clear what kind of impact the guidelines, which are not binding, will have on companies and clinics offering these dubious treatments.

According to an article on the Nature news site:

Olle Lindvall, a professor of neurology at Lund University in Sweden and one of the two co-chairs of the task force, doubts that the guidelines will cause clinics operating outside the scientific mainstream to reform. "More of the clinics are interested in making money than in helping patients," he says. But, he adds, "we hope that governments and regulatory bodies will act so that these clinics will have to close."