Dec. 2, 2009 -- The National Institutes of Health announced it will make 13 new embryonic stem cell lines will be available for federally funded research, and will consider adding 20 more new embryonic stem cell lines to a national registry on Friday.
For eight years, scientists using federal grants had to vie for access to just 21 approved lines, or colonies of stem cells derived from a human embryo. The Bush administration imposed a moratorium on federally-funded research on new embryonic stem cell lines created after August 9, 2001.
But, President Obama overturned the Bush moratorium on March 9 and announced a new process, along with the NIH, for approving federally-funded embryonic research in July. The government no longer considers when an embryonic stem cell line was created, but whether the scientists followed strict ethical guidelines on how the embryo was donated, who gave consent, and that nobody was paid for a donation.
"We have been stealing for this announcement. We have frozen away 100 vials of most of the lines," said Dr. George Daley, director of Stem Cell Transplantation Program Children's Hospital Boston where 11 of the new lines were developed. The two other newly approved lines were developed at The Rockefeller University in New York City under Dr. Ali H. Brivanlou.
The 13 lines are the fist in what the government promises will be hundreds of new embryonic stem cell lines approved for federally funded research.
"The scientific community breathed a huge sigh of relief and said, 'Yay,' now we can continue with the science,'" said Dr. Francis S. Collins, director of the NIH. "What we are talking about today is just the beginning of what is going to be an interesting series of approvals."
Research Restrictions Eased
Even if a scientist does not develop an embryonic stem cell line in his or her lab, they can now apply for federal research money to study the embryonic stem cell lines on the national registry.
All told, the NIH is reviewing 96 pending applications (including the 20 up for review on Friday) from scientists to make their stem cell lines available to researchers through a national registry. Collins estimated at least one hundred more researchers with stem cell lines have told the NIH they plan to apply for approval.
"We have to remember that under the Bush administration, there was a tacit support for the area of stem cell biology, there were just all of these administrative restrictions," said Daley. "I would hope that we have reached a new understanding -- that we can put these debates in the past."
Collins said the government has $21 million in grant money allotted for research on the new lines and the NIH is expecting at least $10 million more next year from Challenge Grants under the American Recovery and Reinvestment Act of 2009.
What the New Guidelines Say About Creating Embryos for Research
Researchers still must create their embryonic stem cell lines with private money under the 1996 Dickey-Wicker Amendment, under which Congress banned federal funding to create embryos for human research if human embryos will be destroyed.
Private money cannot pay for embryo donations, but can fund the process of creating the stem cell lines. All of the embryos in the registry had to be "created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose." They had to be donated with written consent "by individuals who sought reproductive treatment," according to the NIH guidelines.
Once a new stem cell line is derived with private money, researchers can try to make it publically available for research by applying for approval with the NIH.
Daley said federal approval means much more than access for stem cell scientists. Federal money is still the "lifeblood" of most scientific work in the United States, even in Daley's lab, which gets millions of dollars in private funding.
"The NIH funds the vast majority of basic biomedical research," said Daley. "It's the lifeblood for my lab; it's the sustenance for all the high-powered biomedical science."
"There's now 20 million dollars available today that wasn't available yesterday," he said. "But we're still at the beginning. We only have 13 of the potentially 700-800 lines derived worldwide."
Dr. Sean Morrison, director of the University of Michigan Center For Stem Cell Biology, was one of the 31 researchers to receive federal grants for human embryonic stem cell research. He was awarded money three months ago -- but sent a warning that he wasn't allowed to spend it.
"We were temporarily in a worse position than we were under the Bush administration," said Morrison, who had to hold off on hiring anyone for three months before the NIH approved any embryonic stem cell lines for use.
Morrison requested use of embryonic stem cells from Children's Hospital Boston in order to do research on Hirschsprung disease -- a potentially fatal birth defect that makes a portion of a person's intestines useless. He hopes to use stem cells in therapy to develop nerve cells to replace the missing nerve tissue in the colons of Hirchsprung patients.
"Overall I think the NIH policy is good, and now that it is implemented it's going to accelerate science in this country and it's going to get better and better over time," said Morrison. But he pointed out that others will have to wait and that the NIH is dependent upon scientists to voluntarily submit their stem cell lines to the registry.
Alternatives to Embryonic Stem Cell Research?
When asked about those who oppose research on embryonic stem cells for any reason, Collins said he thought the controversy should be put to rest with the new NIH guidelines.
"After all, what we're talking about here are stem cell lines that are developed as part of in vitro fertilization and remain as excess embryos that are not going to be used," Collins said.
Controversy cooled over embryonic stem cell research since the passing of the 2001 regulations, in part because of new research that showed skin cells can be prodded into behaving like embryonic stem cells. Normally only embryonic stem cells are "pluripotent," meaning they are able to turn into any type of cell -- muscle, bone, blood, etc.
But Dr. Shinya Yamanaka showed human skin cells can be induced into pluripotency in 2007, opening up the promise of what is now called iPS or Induced Pluripotent Stem Cells.
Although widely hailed as a way around the ethical problem of destroying embryos in the process of harvesting stem cells, Collins said the advance of iPS was not a replacement for embryonic stem cell research.
"But of course, we still are very early in investigating this [Yamanaka's] dramatic finding," said Collins, who added that there are still a list of very legitimate questions about whether IPS cells and embryonic stem cells are equivalent.
"We'll never know the answer to that unless we do side-by-side research," said Collins.
Researchers say the new stem cell lines not only open up opportunity, but offer better research materials to scientists.
"This is long overdue," said Robert Lanza, Chief Scientific Officer of Advanced Cell Technology, Inc. Lanza's group has just filed with the FDA to begin a clinical trial using embryonic stem cells to treat juvenile blindness.
"Restricting federal research funds to research on a few cell lines created by an arbitrary date in 2001 crippled stem cell research in this country," said Curt R. Freed, Professor and Head of Division of Clinical Pharmacology and Toxicology at University of Colorado School of Medicine.
Freed points out that embryonic cells must be grown in a certain way to be used for humans and that "none of the Bush cell lines met those standards." The new lines will fix that problem.
"What's important about this is that it allows American research to proceed on lines using the best technology and the most advanced technology," said Laurie Zoloth, director of the Center for Bioethics, Science and Society at Northwestern University in Evanston, Ill.
"We've advanced both ethically and scientifically in the last eight years," she said.