Concerns over former President George W. Bush’s federal funding policy of human embryonic stem cell research seemed resolved when President Obama issued Executive Order 13505 in March 2009. Four months later, after notice and comment rulemaking, the NIH issued its Guidelines on Human Stem Cell Research. These Guidelines set forth the requirements for federal funding. On August 23, 2010, District of Columbia District Court Judge Royce Lamberth granted a preliminary injunction against federal funding of human embryonic stem cell research (hESCR), finding that the new NIH guidelines violated the Dickey-Wicker Amendment, an appropriations rider to the Public Health Service Act that has been enacted by Congress and signed into law by Presidents Clinton, Bush and Obama annually since 1995.
The field of stem cell research has accelerated in recent years. To continue the pace of biomedical discovery and its translation into clinical applications, federal funding is critical. Now more than ever it is imperative that we establish legislation that will protect funding of all types of stem cell research.
- Federal funding of human embryonic stem cell research is the will of the American people and Congress. In a recent poll conducted in August 2010 by Research!America, 70% of Americans favor expanded federal funding of research using human embryonic stem cells. In 2005 and 2007, Congress passed Stem Cell Research Enhancement Acts in both the House and Senate specifically removing federal funding restrictions on research with stem cell lines.
- HESC is morally and ethically acceptable. In a RAND corporation study, it was found that over 400,000 IVF embryos were still in storage, dating back to the 1970s. The generation of IVF embryos for reproductive purposes necessitates excess embryos that will be stored indefinitely or destroyed. The creation for ethically responsible research of stem cell lines from these supernumerary embryos that will never be implanted in a womb is a subsequent, determining act that chooses humanitarian benefit over biomedical waste.
- NIH funding is critical to the education and training of the next generation of scientists and to maintaining our nation's competitive advantage in biomedicine. The bulk of NIH funded biomedical research is carried out by graduate students and post-doctorate researchers, who depend on these grant funds for their stipends to meet living expenses. Without NIH funding, many students and post-docs currently on embryonic stem cell research projects will be financially forced to prematurely exit their programs and are at significant risk of losing their research careers entirely.
- Over half a billion dollars of tax payer investment and nearly a decade of scientific progress are in jeopardy. Since 2002, $546 million in NIH funds have been invested in human embryonic stem cell research, with $137 million estimated to have been spent in FY2010. Legislation to secure federal funding of hESC research must be passed to never again risk tax payer investment and scientific progress.
- 1,300 jobs may be lost if federal funding of cell lines from hESCs is not supported by legislative action. 223 hESC projects supporting an estimated 1,300 jobs are NIH funded.
- HESC research is an integral component of an international and burgeoning Regenerative Medicine Industry. The 2008 market for regenerative medicine is estimated between $2-5 billion and the industry has projected sales of $11 billion by 2020. Worldwide, 6100 full-time employees are reported to work in the Regenerative Medicine Industry. In 2008, over 100 companies were involved in stem cell therapies. Globally, 537 stem cell patents were issued in 2007. In the past decade, over $1.46 billion in venture capital has been invested in regenerative medicine. Stem cell research is a national resource, presenting a new frontier for intellectual capital and global commercialization, with significant promise to provide jobs, raise the GDP, and increase tax revenues.
- HESC research has the potential to save over $250 billion in U.S. costs for five diseases it holds significant promise for curing. Heart failure, late-stage Parkinson's, stroke, insulin-dependent diabetes, and spinal cord injury affects over 18 million U.S. citizens costing over $250 billion annually. In 2008, U.S. healthcare costs were $2.4 trillion accounting for 16.6% of the GDP. With an aging population and rising rates of obesity, it is critical to our nation’s economic security that we fully explore all types of cellular therapies for their efficacy to treat these and other chronic and degenerative medical conditions.
- Induced Pluripotent Stem Cells (iPSCs) may at some point provide an acceptable alternative for hESCs as a starting point for deriving cell-based therapies. But the research required to get to that point will necessitate many years of comparison with hESCs as experimental controls. Progress is being made on using small molecules and mRNA as a substitute for the first generation of virus-based vectors of inducing pluripotency but significant hurdles remain in reprogramming clinically safe cells.
- Cell-based therapy derived from hESCs are already being used in a FDA approved clinical trial for the treatment of spinal cord injury. On Oct 11, 2010,Geron enrolled the first patient in phase I of its clinical trial using hESC derived oligodendrocyte progenitors, GRNOPC1 cells. The main objective of this study is to test the safety of these cells.
Scientists, doctors, and patients are inspired by the promise of stem cell research to revolutionize medicine. For the first time in human history we hold within our grasp the cellular potential to regenerate damaged tissue. Instrumental to this field is hESC research. In the last several years, we have seen significant scientific, medical, and commercial progress. An entire industry is maturing with a market of billions of dollars and hundreds of companies are providing jobs to thousands of people. We may soon witness the first clinical proof of safety using hESCs to treat spinal cord injury. Imagine a world where paralysis from spinal cord injury may some day be cured with this technology.




































































