Dec. 2, 2009 - Thirteen human embryonic stem cell lines now are available to U.S. government-funded scientists, and 96 more are in the approval pipeline.
Last March, the Obama administration relaxed Bush-era restrictions on research use of human embryos. The new guidelines took effect last July. They require a review to ensure that the cell lines come from embryos donated under strict ethical guidelines for informed consent.
That review is complete for 13 human embryonic cell lines. Twenty more of these cell lines will complete final review on Friday. A total of 109 cell lines are in the review pipeline -- and "a couple hundred or more other" researchers intend to submit new cell lines for review, says NIH Director Francis S. Collins, MD, PhD.
"There is still a ban on the creation of new embryonic stem cell lines with federal funds, so we are talking about the use of these cell lines and not their derivation in federally funded research," Collins said at a news conference.
Eleven of the newly approved cell lines were established at Children's Hospital, Boston; two were established at Rockefeller University in New York.
"It is gratifying to know that the lines we made at Rockefeller University can now be used by NIH-funded researchers across the country to develop therapies for a wide variety of diseases," Scott Noggle, PhD, director of the stem cell laboratory at the New York Stem Cell Foundation, says in a news release.
Under the Obama administration guidelines, the cell lines must come from embryos created for the purpose of human in vitro fertilization but not needed for that purpose. Donors must be fully informed of their options to freeze the embryos for later use, to destroy them, or to donate them for research. Donors may not be paid or reimbursed for the embryos.
Thirty-one studies, federally funded to the tune of $21 million, are ready to use the cell lines. Many of the studies will look at whether embryonic stem cells can be used to treat currently incurable diseases.
"One of the studies is focused on the use of stem cells tor therapeutic regeneration of heart muscle cells damaged by heart attacks," Collins said. "Another will produce neural stem cells to learn to see whether they can be used for Parkinson's disease. Other studies are focused on basic advances in using these cells, including a culture system for self-renewal to make them available in large quantities."
One study already under way will look at whether embryonic stem cells can help people paralyzed by spinal cord injuries. That trial is on hold due to technical difficulties.
"Now there is a chance for this research to go forward more quickly," Collins said.
In August 2001, the Bush administration limited research on embryonic stem cells to cell lines established before that date.
"Those were the early days of stem cell research, and much has been learned since then," Collins said. "Over the last eight years, using non-federal funds, hundreds of embryonic stem cell lines have been derived. The policy we now are following allows those lines to be considered for federally funded research, as well as others established in the future with no-federal funds."