No fast start
A year after limits lifted, process goes slowly to get stem-cell research moving
Progress to advance U.S. stem-cell research has been slow but steady since President Barack Obama revoked a policy that had limited this area of scientific study for nearly eight years. This month marks the one-year anniversary of Obama’s announcement that overturned the August 2001 order by President George W. Bush that limited the amount of federal funding for stem-cell research.
Bush’s statement said federal funding could not be used for such research unless certain conditions were met: the derivation process—which starts with the destruction of an embryo—must have been initiated before Aug. 9, 2001; the stem cells must have been taken from an embryo that was created for reproductive purposes and no longer needed; and informed consent must have been obtained for the donation of an embryo that was obtained without financial inducements.
Stem cells, which are unspecialized cells that have the capability of renewing themselves through cell division—even after long periods of inactivity—can also give rise to specialized cells for tissues or organs under certain physiological or experimental conditions, according to the National Institutes of Health. Because of their regenerative abilities, these cells could create the potential for treating conditions such as diabetes and Parkinson’s and heart disease.
With his order last year, Obama opened the nation’s $29 billion budget for stem-cell research (March 16, 2009, p. 6) and also lifted the limitations that Children’s Hospital Boston physician scientist Leonard Zon said have “greatly hampered” the ability to conduct research in this field.
Zon said that even though money is being spent and scientists are able to do research, the process by which stem-cell lines are available under NIH funding has taken a little more time than people thought. “After the ban, there has been a little bit of lag time to get up to speed,” said Zon, director of Children’s stem-cell program.
That process began with draft guidelines for research involving human embryonic stem cells, which the NIH released in late April 2009. The NIH received 49,000 public comments from patient advocacy groups, scien- tists, scientific societies, medical societies, academic institutions, religious organizations and private citizens before the guidelines became effective on July 7, 2009. In early December, the agency said it had approved 13 human embryonic stem-cell lines for use in NIH-funded research.
A representative for the NIH was unavail- able for an interview, but a spokesman said in an e-mail that the fiscal 2009 figure for human embryonic stem-cell research was $143 million, which includes $14 million from the American Recovery and Reinvestment Act of 2009, also known as the stimulus law. The fiscal 2010 funding amount is expected to be $137 million, including $23 million from the stimulus law.
In the last year, Zon has worked closely with colleague George Daley and a team at Children’ Hospital—which produced 11 of those 13 lines the NIH approved—to develop a new Web site that is intended to debunk some of the myths about stem-cell research and also educate patients.
“The promises of stem-cell research are real, but we also want to be accurate in what can be done and what can’t be done,” said Zon, who added that he receives a call each week from someone wanting to travel outside the United States for treatment. “There are companies in China that will inject weird things into you with a promise that they will cure diabetes,” said Zon, who acknowledged that a person with a serious disease “might be willing to try anything.”
Children’s Hospital’s new Web site, stemcellchildrenshospital.org, is scheduled to launch on April 26. Zon said the idea behind the Web site is to give people the tools to understand the research so that they can educate others. “The biggest misconception has to do with embryonic stem cells,” Zon said, adding that most people picture a fetus when they think of stem cells. “When we’re making these lines, there is no nervous system or tissue except a solid ball of cells.”
Donald Gibbons is the chief communications officer at the California Institute for Regenerative Medicine, a granting agency in Sacramento that was created after California voters took the initiative to advance stem-cell research efforts in the absence of federal funding.
In 2004, voters passed a referendum that allowed for $3 billion in bonds to fund stem-cell research for 10 years, according to Gibbons, who said the institute has awarded $1 billion of those funds to date, including $270 million that was used to build 12 stemcell facilities.
As Gibbons explained, there was much excitement in the field when the segment learned a year ago that it had a partner in the federal government. He also said he fears that the public might not understand how many different types of stem cells there are, and how long it will take to move beyond the clinical research phase to the approval phase.
Earlier this month, the California Institute for Regenerative Medicine allocated $50 million for stem-cell therapy development. “This funding will help speed the pace of moving these potential therapies through clinical trials and, if those trials prove successful, into doctors’ offices,” the institute said in a March 11 news release.
At 396-bed Children’s Hospital, Zon said one area of stem-cell research that requires improvement is making organs from stem cells. “We’ve learned how to make the cells,” Zon said. “Now let’s learn how to make them useful.”
The NIH has approved 13 new stem-cell lines for research.