Feds ease restrictions on use of stem cells

By Shankar Vedantam, Washington Post

From SFGate.com

Hundreds of embryonic stem cell lines, whose use in the United States had been curtailed by the Bush administration, can be used to study disorders and develop cures if researchers can show the cells were derived using ethical procedures, according to new rules issued by the federal government Monday.

President Obama had promised during last year’s campaign to ease restrictions on the use of stem cells in research, and has cited the promise of stem cells in finding cures for disorders that have so far proved intractable.

The use of embryonic stem cells was not prohibited under the Bush administration, but federal funds were limited to a very small number of stem cell lines, which choked off most research. The new guidelines, issued by the National Institutes of Health, permit federal funding for research using many of the approximately 700 embryonic stem cell lines that are believed to be in existence.

In a move that drew praise from advocates of stem cell research and bitter criticism from opponents, the NIH said it will allow the use of any existing stem cell line that followed broad ethical principles. Acting NIH Director Raynard Kington said an NIH committee including scientists, ethicists and advocates will evaluate older stem cell lines to assess how each was derived.

He said all embryonic stem cell lines that qualified for federal funding would have to meet a series of ethical requirements: The embryo that was destroyed to create a stem cell line must have been discarded by couples following an in vitro fertilization procedure, and the donors must have been informed that the embryo would be destroyed for stem cell research and made fully cognizant of their choices, including donating the embryo to another couple who want a baby. No donors could have been paid for an embryo, and no threats or inducements could have been used to nudge couples toward donating an embryo.

Kington said the NIH would set up a Web site that would list all the approved stem cell lines.

Almost all of the stem cell lines developed in California are expected to meet the NIH ethics guidelines, said Geoffrey Lomax, senior officer for medical and ethical standards with the California Institute for Regenerative Medicine. The institute was created by a voter initiative in 2004 to support stem cell research.

Lomax said the registry should be a boon to researchers in California by making it easier to use stem cell lines from other states. Previously, scientists would have spent valuable time and money determining whether an out-of-state line met California ethical criteria before they could begin their research. With a national database, they can skip that first step, Lomax said.

“This (registry) will speed things up a bit,” Lomax said. “It creates a level of standardization that is extraordinarily helpful and it removes a lot of uncertainty.”

The use of stem cells in research has become the subject of bitter national controversy, with advocates suggesting it is immoral for the federal government not to fund research that could save thousands of lives, and with opponents arguing it is immoral to fund research that involves destroying embryos.

Chronicle staff writer Erin Allday contributed to this report.

California Stem Cell Chief Seeks Trials in Four Years

By Rob Waters, Bloombeg.com

California’s $3 billion stem-cell funding agency wants to get 10 to 12 new therapies into human testing within four years, said the agency’s president, Alan Trounson.

In December, the California Institute of Regenerative Medicine plans to award grants of about $20 million each to 10 or 12 teams, with the goal of starting clinical trials within four years, Trounson said today in an interview. Most or all of the teams will include biotechnology companies, he said.

The San Francisco-based institute, established by voters in 2004, is putting greater emphasis on advancing research from laboratory testing to patient trials, said Trounson. After years of stem cell research being conducted largely by academics, companies are deepening their investment in the field, he said. The agency eventually would like to draw in big pharmaceutical companies to help fund the research.

“Pharma is moving into this space in a big way,” Trounson said. “They’re now generally interested in cell therapy. That’s a big change.”

Trounson, a former academic and biotechnology executive who assumed leadership of the institute in January 2008, said he is talking to companies on a regular basis about setting up partnerships.

While the agency now funds some small companies to advance promising stem-cell therapies, Trounson said he is looking for ways to attract investment by larger companies to develop treatments. In the long run, the agency may try to use industry funding to continue operating once its $3 billion in state bond revenue is exhausted by the end of the next decade, he said.

Grants to Companies, Academics
In April, the agency awarded 15 “early translational” grants totaling $67.7 million. Two of the grants totaling $11.1 million went to companies. Most of the $761 million the institute has given out so far have gone to academic institutions such as Stanford University, the Scripps Institute and various campuses of the University of California.

A deepening budget crisis in California caused by a 27 percent drop in revenue over the past year hasn’t stopped bond sales for the agency, which currently has enough cash to last through 2011, Trounson said.

Trounson said the institute receives no funding from the state’s general fund.

“Cuts to us would be purely symbolic,” he said. “Our focus is to do something to help people in the community suffering from horrible diseases.”

Institute funding of new research facilities throughout the state has also stimulated the economy and created thousands of construction jobs, Trounson said.