President Obama, at a White House ceremony on Monday, announced a lifting of the eight-year ban on federal support of stem cell research that was imposed by President Bush in 2001. While no decisions have yet been made about expansion of federal funding for embryonic stem cell research, today’s move holds great promise for the future of science in our Country and has the potential to exert a profound effect on the future of medicine.
Stem cells are renewable cells that are found in embryos, and in adults in many fewer numbers. As opposed to the typical cells found in the adult— which cannot continue to actively divide and change their characteristics— these cells can actively divide and replenish themselves for long periods of time, and can be induced to become more specialized cells with specific functions such as the beating cells of the heart muscle or the insulin-producing cells of the pancreas.
Although adult stem cells can then be induced to form different cell types in the laboratory, it is much more difficult. Embryonic stem cells are so important because they can more easily be
induced to form specialized cell types (differentiation) than adult
stem cells, which can divide but are already programmed to form
specialized cells (such as muscle, blood cells, intestinal cells) in
order to replenish adult cells that are lost through normal attrition.
As with most research related to human biology, stem cell science was first developed in mouse models. Embryonic stem cells were first isolated from mouse embryos over 20 years ago and human embryonic stem cells were first isolated in 1998. These cells were isolated from 4 to 5 day human embryos that were created for in vitro fertilization processes with the consent of the donor. These cells were then used to create cell lines, which are cells that can be grown in the laboratory and used by many investigators for scientific endeavors.
The enormous excitement surrounding embryonic stem cell research is primarily due to contributions that embryonic stem cells can make to so called regenerative medicine (use of stems cells for the development of functional cells, tissue or organ substitutes to repair or replace those damaged by abnormalities, aging, disease or injury) and therapeutic cloning (so called custom embryonic stem cells derived from an individual’s own DNA and a donor egg which are used to form a blastocyst from which personalized embryonic stem cells can be derived) . Not only does embryonic stem cell research have the potential to contribute to the management and treatment of a large number of diseases such as diabetes, spinal cord injuries, cardiac disease, Parkinson’s and Alzheimer’s disease, they also have a large potential for scientists to learn about human cell growth and development, which also has the ability to contribute to the understanding of how to control cancer. Due to the controversy and lack of federal funding for embryonic stem cell research, scientists have turned their efforts to adult stem cell research and have been successful in developing this science, but the greatest hopes are held for the use of embryonic stem cells due to their enhanced proficiency at cell division and plasticity (ability to be induced to form a variety of cell types).
The controversy surrounding the use of human stem cells has been based in the belief of some that life begins at conception and that the destruction of a human embryo is unethical and immoral. This belief has been the major obstacle impeding the use of embryonic stem cells to advance science and the cure of human disease. President Bush issued a decision in 2001 that limited federal funding of embryonic stem cell research to 70 cell lines that already existed at that time. President Bush viewed this as a compromise that allowed science to proceed without using tax payer money to promote the destruction of embryos. However, over the years since this decision the number of viable stem cell lines has decreased from 70 to 20, and these lines have been contaminated, thus limiting their usefulness. For others, the medical benefits outweigh these concerns. The UK, Belgium, Sweden, Japan, China and South Korea have allowed embryonic stem cell cloning. The EU does provide funding for countries which embrace embryonic stem cell research.
President Obama promised in his inaugural address to “restore science to its rightful place.” Today’s announcement will lift eight years of tight restrictions on embryonic stem cell research. This anticipated policy change will free up the use of hundreds of newer cell colonies that have been off-limits under President Bush for federally funded scientists. Previously these cell lines could be used only by researchers funded from private sources. It is anticipated that President Obama will not announce the details of Federal support of embryonic stem cell research, but will allow the National Institutes of Health to craft the policies on how funds will be used to support this work.
The Obama policy change is expected to be not only a source of funding for scientists, but also a symbolic positive for embryonic stem cell research. Federal funding for research primarily is distributed to government agencies and academic institutions, but also sets the tone for research avenues. Indeed, many investigators’ have their academic careers intimately tied to their ability to secure federal funding for their research.
Similar to when recombinant DNA technology and gene therapy were developed, a lifting of restrictions to a sophisticated and controversial type of research does not translate into an instant explosion of scientific findings. Detailed ethical and scientific guidelines will have to be crafted by the NIH, outlining how federal dollars can support research involving human embryos. Laws will also have to be crafted which further outline how stem cell lines can be created.
The FDA will have to also regulate and monitor the safety of this type of work in humans. Recently, the first clinical trial using embryonic stem cells was approved by the FDA in January of 2009.
Patients with spinal cord injuries will be first humans to receive cells derived from embryonic stem cells. Patients who are paralyzed from the chest down will have injury sites injected with cells that hopefully will restore connections and repair damage. Also in January of 2009, a UK company received approval to inject stem cells into the brain with the goal of repairing tissue damaged by strokes.
Federal policies on research often set the standards for ethical
scientific research and the federal approval for stem cell research
will contribute to the credibility of this research avenue and also
would be expected to expand private funding. Indeed, after hours
trading this weekend of companies involved in stem cell research have
demonstrated a new infusion of money into these biotechnology markets. It is also hoped that some of the funds that were awarded to
the NIH under the economic stimulus plan will be used for research
projects employing the promise of embryonic stem cell research.
This is an exciting time in science and medicine. As science becomes more sophisticated, many times ethical and safety issues also become increasingly more complex. We are a sophisticated country with strong moral values, and we also have a commitment to use our discoveries to advance health and medicine in a responsible manner. These two aspects of our culture need not be mutually exclusive. I look forward to writing about future advances based on this exciting new avenue for science and medicine.