바이오인

 

 

 

2 Introduction and Summary
  2 A Call to Innovation
  3 A New Federal Embryonic Stem Cell Research Agenda
6 Glossary
8 New Science, New Promise; Old Policies, Old Debates
  9 The scientific case for human embryonic stem cell research
  9 A Brief History of Human Stem Cell Research
  10 The Ethics of Procuring Human Embryonic Stem Cells
  12 The inadequacy of the old policies
  13 Current and Future Regulation of Human Embryonic Stem Cell Research
17 Short-Term Policy Recommendations
  17 Recommendations for the President
  18 Recommendations for HHS and NIH
  19 Recommendations for Congress
  19 Recommendations for a Stem Cell Registry and Stem Cell Bank
  19 Current Stem Cell Legislation
22 Long-Term Policy Issues
  22 State Issues
  23 Innovation and Intellectual Property Issues
  25 Expanded Recombinant DNA Advisory Committee
  27 Recent Scientific Discoveries in Stem Cell and Regenerative Medical Research
30 Endnotes
32 About the Authors and Acknowledgements

 

 

It is time for the United States to stake its claim as the world leader in regenerative medicine,
which promises to become a vital component of the cutting edge of life sciences research and innovation in the 21st century. To ensure research in this newly emerging field of life sciences is conducted responsibly and ethically, the federal government must reform its stem cell research policy in order to fund embryonic stem cell research that is robust and comprehensive as well as cautious and principled.

Regenerative medicine is a new therapeutic approach that works by cultivating a small sample of a patient’s own cells, reprogramming them, and using them to heal the patient without the risk of rejection or severe side effects that usually result from introducing foreign
therapeutic materials. The potential therapies range from transforming the pancreatic cells of diabetics so they can produce insulin to reconnecting the nerves in severed spinal cords. Indeed, there have already been some modest clinical applications where heart muscles and cartilage have been repaired with stem cells derived from bone marrow.

But that is just the tip of the iceberg. The greatest potential for regenerative medicine lies in scientists’ ability to tap into the process of cell differentiation and development. This can only be achieved by tracing the development of human cells from the very beginning. To do so, scientists need to conduct research on embryonic stem cells so that they can discover
how these all-purpose cells can change into any one of the more than 200 different cell types in the human body.

Moreover, by studying the development of embryonic stem cells scientists will be able to discover how the human genome goes about manifesting itself and creating unique individual persons. These efforts will provide us with unprecedented insights into human development, how it can go wrong, and how it can be fixed.

Opponents of embryonic stem cell research argue that there have been many scientific advances made using stem cells that do not come from embryos, such as bone marrow-derived stem cells, which are a type of adult stem cell. Opponents also point to so-called induced pluripotent stem cells, which are created when adult cells-say, skin cells-are reprogrammed to become all-purpose “pluripotent” cells. These arguments are valid, but
only up to a point. The reason: embryonic stem cells are both the original “master cells” capable of turning into any cell in the body as well as the “gold standard” against which all other stem cells must be compared

 

Scientists determine whether other types of stem cells hold the promise of delivering the kinds of regenerative medicine envisioned by life scientists by analyzing the surfaces of these alternative cells to see whether they have the same proteins and therefore the same capabilities as embryonic stem cells. Evidence suggests that these stem cell-specific proteins activate certain chemical pathways in the stem cells, which in turn allow them to maintain their pluripotency. Regardless of what type of stem cells prove to be the most useful, this process of embryonic stem cell comparison must be carried out for each therapeutic application, whether for Alzheimer’s disease, Parkinson’s disease, spinal cord injuries, or any of the other myriad conditions for which stem cell therapy might be possible.

Just as important: embryonic stem cells must be studied so that scientists can learn more about developmental biology. It is a longstanding research paradigm to study failures of development by determining when, where, and how genes malfunction. The ultimate goal is to develop a guidebook that will tell us exactly how each gene or combination of genes contributes to the development of a unique individual. This will greatly enhance our understanding of basic genetics and could allow scientists to develop drugs that can prevent the diseases from developing in the first place.

Additionally, embryonic stem cells can aid in the refinement of these new drugs since the cells can be differentiated into specific cell types upon which scientists can quickly test whether a drug has a desired effect. This will make the drug development process and then the clinical trial process much safer and more efficient.

The bottom line is that embryonic stem cell research is good science. It is necessary science, and it needs to be part of America’s federally funded biomedical research enterprise if America is to retain its status as a global scientific leader. That’s why embryonic stem cell research must be conducted responsibly and ethically, and why the incoming Obama administration must outline new federal research and funding oversight guidelines for embryonic stem cell research that are cautious and principled.