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Dec 2, 2009

First Human Embryonic Stem Cell Lines Approved under New NIH Guidelines

  • NIH director, Francis S. Collins, M.D., Ph.D., today announced the approval of the first 13 human embryonic stem cell (hESC) lines for use in NIH-funded research under the recently adopted NIH Guidelines for Human Stem Cell Research.

    “In accordance with the guidelines, these stem cell lines were derived from embryos that were donated under ethically sound, informed-consent processes,” points out Dr. Collins. “More lines are under review now, and we anticipate continuing to expand this list of responsibly derived lines eligible for NIH funding."

    Children's Hospital Boston developed 11 of the approved lines, and The Rockefeller University in New York City developed the other two. 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). 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.

    Over 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, these principal investigators may obtain registry-listed hESCs  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.

    On March 9, President Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The executive order stated that the secretary of the HHS, through the director of NIH, may support and conduct responsible, scientifically worthy human stem cell research including human embryonic stem cell research to the extent permitted by law.

    The NIH Guidelines for Human Stem Cell Research, published on July 7, implement the executive order as it pertains to extramural NIH-funded stem cell research, establish policy and procedures under which the NIH will fund such research, and help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.

     



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