First Human Embryonic Stem Cell Lines Approved for Use under New NIH Guidelines
In early December 2009, National Institutes of Health (NIH) Director Francis S. Collins, Ph.D., M.D., announced the approval of the first 13 human embryonic stem cell (hESC) lines for use in NIH-funded research under the NIH Guidelines for Human Stem Cell Research adopted in July 2009.
"I am happy to say that we now have human embryonic stem cell lines eligible for use by our research community under our new stem cell policy," Dr. Collins said. "In accordance with the guidelines, these stem cell lines were derived from embryos that were donated under ethically sound informed consent processes. 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 first 13 approved lines and Rockefeller University in New York City developed two. Also, during December 2009, 27 lines developed by Harvard University were approved, bringing the total number of approved lines to 40. By the end of 2009, 90 additional cell lines had been submitted to the NIH by multiple institutions, and more than 200 lines were in the draft stage of the submission process.
Information about these cell lines is available at the NIH Human Embryonic Stem Cell Registry website at http://grants.nih.gov/stem_cells/registry/current.htm. Detailed information for approved cell lines can be accessed through a "Details" link in the far left column of the table of approved cell lines. Details for a selected cell line may include restrictions that apply to the specific line. These limitations are placed on the use of the hESCs by the provider of the line or by the NIH. For example, the provider may restrict the line to noncommercial use only. Limitations may also exist due to specific language in the informed consent. Accordingly, grantees must honor all restrictions when using the line.
Submissions to the NIH receive 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. The NIH director decides whether the hESCs may be used in NIH-funded research, and cell lines deemed eligible are then listed on the NIH Human Embryonic Stem Cell Registry.
Research using hESCs is already yielding information about the complex events that occurduring 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.
On March 9, 2009, President Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The Executive Order states that the secretary of Health and Human Services, through the director of the NIH, may support and conduct responsible, scientifically worthy human stem cell research, including hESC research, to the extent permitted by law.
The NIH Guidelines for Human Stem Cell Research were published on July 7, 2009, and are available at http://stemcells.nih.gov/policy/2009guidelines.htm. The guidelines 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 laws.
More than 30 NIH grants funded in the 2009 fiscal year-totaling more than $20 million- proposed to use hESCs, but these grants were restricted until approved lines became available on the NIH registry. Now, with NIH approval, the principal investigators of these grants 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. Researchers examining other topics that could benefit from the use of hESCs are encouraged to apply for funding to use these approved lines.
For additional information about stem cells and NIH research, visit http://stemcells.nih.gov.
NIH Publication No. 10-4562