National Institutes of Health Director Francis Collins announced today that the first 13 human embryonic stem (ES) cell lines have been approved for funding under the expanded policy outlined by President Barack Obama in an executive order last March. He said another 20 are likely to be added to the list any day now, but the final list could top 100.
NIH officials have proceeded as fast as they could to fashion new guidelines to replace the Bush-era restrictions. Until now, federally-funded scientists have only had access to 21 cell lines created before 9 August 2001, the day President George Bush announced his policy. Draft guidelines were issued last spring; final ones came out in July. In September, NIH opened a Web site where government-funded scientists can fill out a form requesting approval for the use of particular cell lines.
Opponents slammed the move as immoral. "We don't think any taxpayer should have to fund research that relies on destroying early human life," said Richard Doerflinger of the U.S. Conference of Catholic Bishops.
Scientists who wish to use embryonic cells have been generally happy with the final guidelines. They worried that, under exacting new requirements for informed consent by embryo donors, most of the Bush-approved lines wouldn't make the grade, but NIH has fashioned a two-tiered vetting process which allows for some flexibility in considering older lines.
How many lines will ultimately qualify for NIH funding is not yet clear.
Former NIH Acting Director Raynard Kington estimated that around 700 lines are in use today but predicted only a fraction were likely to qualify under the new policy. Collins indicated today that a couple of hundred are likely to be available soon.
Currently, eight groups have submitted 109 lines to NIH for consideration. The 13 newly approved ones include 11 derived at Harvard University in the lab of stem cell researcher George Daley, and two from the lab of Ali Brivanlou at Rockefeller University. Collins said that in addition to the 20 on the verge of being approved, there are "more than 100 additional ones for which we have evidence that there is going to be a submission."
Collins said he didn't know how many of the 21 Bush-approved lines would make the grade; only one so far, from the University of Wisconsin, is in the approval pipeline.
NIH ES cell money can now start flowing. Collins said there are 31 grants, totaling $21 million, that have been on hold pending approval of the first cell lines. Now, he said, "Those 31 can look at the registry and decide which lines there they would like to start work with." And what will total dollar figures look like? "There's no ceiling," said Collins, citing "this wonderful engine of discovery that has been revved up" with recovery funds. But he warned that research may run into "serious stress when recovery money runs out" in 2 years.
Asked if the development of induced pluripotent stem (iPS) cells has reduced scientists' need to work with human ES cells, Collins said "we are still very early in investigating this dramatic finding. There's still a very legitimate series of questions about whether iPS and ES cells are equivalent. ... We will never know the answer if we don't have the capability to do rigorous side-by-side comparisons."