BETHESDA, MD— The first new embryonic stem cell lines for use in NIH-funded research in over eight years were announced last month. The 13 lines will be made available under the NIH Guidelines for Human Stem Cell Research adopted in July 2009.

In March, President Obama issued an executive order removing barriers to federal funding for research using stem cell lines discovered after August 9, 2001, when President Bush signed an executive order limiting federal funding to just those lines already in existence. President Obama asked NIH to issue new federal guidance on stem cell use, which the agency did, releasing the draft guidelines in July.

Children’s Hospital Boston developed 11 of the newly approved lines and Rockefeller University in New York City developed the other two. The external Working Group has submitted an additional 96 lines to NIH for either internal administrative review or consideration for Human Embryonic Stem Cell Eligibility Review and the NIH Advisory Committee to the Director. Of those, 20 were scheduled to be considered by the committee when they met last month.

The working group provides findings to the ACD, which makes recommendations to the NIH Director, who decides whether the hESCs may be used in NIH-funded research and lists those deemed eligible on the NIH Human Embryonic Stem Cell Registry.

Children’s Hospital Boston and Rockefeller University submitted information about the informed consent process for embryo donation to the NIH administrative review process, which confirms that the submissions met specific requirements regarding informed consent for embryo donation as detailed in the guidelines.

More than 30 NIH grants funded in the 2009 fiscal year totaling more than $20 million proposed to use hESCs; these grants have been restricted until approved lines became available on the NIH registry. With last month’s announcement and following NIH approval, these principal investigators may obtain registry-listed hESCs, if they are appropriate for their project, from the owners of the lines and proceed with their research. This group of grants includes research using hESCs for the therapeutic regeneration of diseased or damaged heart muscle cells; developing systems for the production of neural stem cells and different types of neurons from hESCs in culture; and developing a cell culture system for the large scale production and self-renewal of hESCs.

In addition, a number of Challenge Grant applications, which could be funded through the American Recovery and Reinvestment Act in the 2010 fiscal year, proposed to use hESCs. Researchers examining other topics that could benefit from the use of hESCs are encouraged to apply for funding using the currently approved lines.

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