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Stem Cell Regulatory Climate


Stem cell technologies are anticipated to provide the stimulus for cellular repair or regeneration.  This can be achieved in different ways: by administering stem cells, or specific cells that are derived from stem cells in the laboratory or by administering drugs that coax stem cells that are already present in tissues to more efficiently repair the involved tissue.

George W. Bush was the first president to allow federal money to be used to fund embryonic stem cell research; but, limited it to about 60 existing stem cell lines created from embryos already frozen in fertility clinics.  According to the National Institutes of Health (NIH), out of 88 lines 21 were actually available to researchers.

The stem cell research industry is being given a lift by “evolving” the restrictions of government funding.  The Obama administration drafted (3/09) guidelines for federal funding of human embryonic stem cell research.  The plan lifts some but not all federal financing restrictions.  The executive order ended an 8½ year ban on federal funding for embryonic stem cell research paving the way for a significant amount of federal funds to flow to science.  The administration “asked” the NIH to draft guidelines that would address both scientific and ethical concerns to allow research with federal financing only on stem cells derived from surplus embryos at fertility clinics.  The money would still be prohibited for stem cell lines created solely for research purposes and for embryos created through a technique known as therapeutic cloning.

  • Funding would be allowed “only” for research using human embryonic stem cells from embryos created solely for reproductive purposes by in-vitro fertilization, 
  • Funding for research using adult stem cells and induced pluripotent stem cells will continue, 
  • Funding will not be allowed for stem cells obtained from other sources, including somatic cell nuclear transfer, also known as cloning; in vitro fertilization embryos created specifically for research purposes; and parthenogenesis, the development of an unfertilized egg.

Bottom Line: The Obama administration took an “easy” political path on embryonic stem cells by “proposing” to pay for research only on stem cell lines created from surplus embryos at fertility clinics but “not” on lines created in the laboratory to study particular diseases,

  • Researchers may use federal money to work with hESC lines; but, cannot use that money to derive those cell lines; however members of Congress are discussing dropping the restriction,
  • The new climate in Washington may offer a chance to scuttle the Dickey-Wicker amendment which forbids use of federal funding to create an embryo or destroy an embryo for research,
  • The proposal continues to deny federal financing to some potentially promising research,  
  • Under the new guidelines, federal funding would be allowed only for research using human embryonic stem cells from embryos created solely for reproductive purposes by in vitro fertilization.  The embryos would have to no longer be needed for reproduction, and the donors would have to consent to their use for research, 
  • Funding for research using adult stem cells and induced pluripotent stem cells will continue. 
  • Funding will not be allowed for stem cells obtained from other sources, including somatic cell nuclear transfer, also known as cloning; in vitro fertilization embryos created specifically for research purposes; and parthenogenesis, the development of an unfertilized egg,  
  • Without federal support for stem cell research, states have stepped in.  California, the leader, approved almost $700 M in grants.  Other states that joined the race include Illinois, Maryland, Massachusetts, New Jersey, New York and Wisconsin, 
  • The state initiatives are advancing science, but in a “fragmented” way, 
  • Allowing the NIH to coordinate and eliminate redundancy; I hope speeds progress.