The San Jose Mercury News (California)

SAN FRANCISCO, CA — California voters, wooed by an aggressive, multimillion dollar campaign that promised cures to myriad diseases, overwhelmingly approved the nation’s most ambitious stem cell research center two years ago.

Now, $181 million is set to flow to cash-starved scientists struggling in a field financially and politically hamstrung by Bush administration opposition and lawsuits filed by conservative organizations against the center.

The California Institute for Regenerative Medicine managed to push out $14 million in “training grants” for young researchers last year, but much of the money it doles out in 2007 will finally go to senior scientists eager to push stem cell research out of the lab and into patients.

But don’t expect those promised cures anytime soon. The research is in such a nascent stage that even fundamental questions such as what defines a human embryonic stem cell remain unanswered.

When the committee that runs the center meets to adopt a 10-year scientific plan Thursday it is expected to acknowledge that routine, widespread stem-cell treatments are unlikely to arise within a decade.

“Our aspirational goal is to cure disease,” said Zach Hall, the institute’s president and top scientist. “But you can’t snap your fingers and have that done.”

Hall said the institute’s immediate goal is to bring “new ideas and people into the field.”

Voters passed Proposition 71 in 2004 to create the institute and give it authority to borrow and spend $3 billion over 10 years. Lawsuits, however, have prevented it from going to the Wall Street bond market for its money.

So the institute will fund the next rounds of grant-giving with a $150 million loan from the state and another $31 million in loans from philanthropic organizations such as the Gordon and Betty Moore Foundation, which chipped in $10 million.

A grant-review committee led by 15 scientists from outside of California last week sifted through 232 applications from state researchers vying for 30 grants worth a combined $24 million. Many of the grants will go to scientists getting into stem cell research for the first time and will be formally awarded in February.

In March, another round of 25 grants worth about $80 million will go to established stem cell scientists.

The most ambitious goal of the center’s 150-page plan is to move the research out of the laboratory and into preliminary tests on people within 10 years. No known researcher has yet tested human embryonic stem cells in patients as scientists continue to puzzle out whether the cells will work properly when implanted into the body and not turn into tumors.

The plan concedes the agency probably won’t fund larger-scale, pivotal trials required for Food and Drug Administration approval.

“That really stands in contrast to the rhetoric used during the campaign,” said Jesse Reynolds, a longtime agency critic at the politically liberal Center for Genetics and Society in Oakland. “The expectations and the timeline in the strategic plan are realistic, but it shows how the institute has had to engage in expectation management since Proposition 71‘s passage.”

Proposition backers spent more than $40 million during the 2004 campaign that included television advertisements featuring actors Michael J. Fox and the paraplegic Christopher Reeve, who died days after filming his spot.

“People were left with the impression that Superman would walk again,” said John Simpson, another critic at the Foundation for Taxpayer and Consumer Rights in Los Angeles.

Human embryonic stem cells are created in the first days after conception and give rise to all the organs and tissues in the human body. Scientists hope they can someday use stem cells to replace diseased tissue, but many social conservatives, including President Bush, oppose the work because embryos are destroyed during research. The microscopic embryos are days old and usually donated by fertility clinics.

Proposition 71 came as a reaction to the Bush administration’s 2001 decision to cap federal funding for stem cell research at about $25 million annually and impose strict research guidelines that scientists say limit advances.

Five states have also skirted federal restrictions with stem cell research funding schemes of their own: Connecticut has a 10-year, $100 million initiative; Illinois spent $10 million last year; Maryland has approved a $15
million budget; and New Jersey has spent about $25 million in two years.

None approach California’s ambition of spending about $300 million a year for the next decade, which California voters overwhelmingly approved two years ago when they passed the California Stem Cell Research and Cures Initiative.

The institute’s chairman, Robert Klein, who led the Proposition 71 campaign and donated $3 million to it, said the fruits from the state-funded research will go beyond creating new medicines.

Researchers will now have the money to create realistic disease models in the laboratory, which will give them better insight into illness and allow them to test more experimental drugs for toxicity in test tubes rather than humans.

“That’s a tremendous benefit to the public,” Klein said.

On Thursday, the 29-member committee that oversees the institute will also consider draft rules on how to ensure the state gets a slice of any profits made from products created with institute grants.

The new awards were made possible by $181 million in state and private loans as two lawsuits challenging the institute’s constitutionality block borrowing $3 billion from traditional bond markets.

A superior court judge earlier this year ruled in the institute’s favor, but it is still shut out of the bond market until appeals are exhausted sometime next year.

“Stem cell research is in its infancy and we may not realize its full promise for many years,” said banking billionaire Marion Sandler after announcing a $5 million loan from the Sandler Family Supporting Foundation last week. “By supporting the institute now, we hope to see that promise fulfilled as quickly as possible.”

On the Net: California Institute for Regenerative Medicine: http://www.cirm.ca.gov