Thirteen New Stem Cells Lines Receive NIH Approval

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NIH Director Francis S. Collins, M.D., Ph.D. made the announcement Wednesday regarding the approval of 13 human embryonic stem cell (hESC) lines for use in NIH-funded research. These are the first to be approved under the NIH Guidelines for Human Stem Cell Research adopted in July 2009. The guidelines can be read here.

The new guidelines were a result of President Obama’s Executive Order 13505 issued on March 9, 2009 intended to remove many of the barriers involving use of human stem cells in responsible scientific research. The executive order allows the Secretary of Health and Human Services, through the Director of NIH, to support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.

According to Dr. Collins , all of the 13 stem cell lines were derived in accordance with the guidelines from embryos that were donated under ethically sound informed consent processes. She reported that more lines are under review.

Children's Hospital Boston developed 11 of the approved lines and Rockefeller University in New York City developed two of the approved lines. The NIH Human Embryonic Stem Cell Registry of approved hESCs is found here.

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An additional 96 lines have been submitted to NIH for either internal administrative review or consideration by the external Working Group for Human Embryonic Stem Cell Eligibility Review and the NIH Advisory Committee to the Director (ACD), including more than 20 that will be considered by the ACD on December 4, 2009. 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.

Research using hESCs is already yielding information about the complex events that occur during human development. Researchers hope that eventually cells differentiated from hESCs may be used to treat a myriad of diseases, conditions, and disabilities and to test the safety of new drugs in the laboratory.

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 today'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 these approved lines.

For additional information on stem cells and NIH research, go to http://stemcells.nih.gov/.

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