Stem Cells and the Future of Regenerative Medicine (2002) / Chapter Skim
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4. Opportunities for and Barriers to Progress in Stem Cell Research for Regenerative Medicine
4. Opportunities for and Barriers to Progress in Stem Cell Research for Regenerative Medicine
Pages 41-54
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From page 41... ...
have the advantage of multipotency and have shown themselves to be readily culturable in the laboratory. Although the degree of plasticity of adult stem cells is still unknown and there are difficulties in purifying and culturing them, the only proven stem ceD-based medical therapies that are currently available rely on adult-derived stem cells from bone marrow and skin, and adult stem cells from other tissues might someday provide therapies that stimulate the body's own regenerative potential.
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From page 42... ...
As knowledge of stem cells grows, investigators will be able to ask meaningful questions about therapeutic approaches, including whether to implant cells in an undifferentiated state or a differentiated state, and which of the various sources of stem cells are best suited to address a specific clinical need. It may become apparent that combined therapies (transplanting multiple stem cell types, or using gene therapy in combination with stem cells transplants)
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From page 43... ...
ESCs exhibit many properties whose improved understanding could assist researchers in modifying adult stem cells to achieve better growth in culture and greater capacity for controlled differentiation. USE OF EMBRYOS FOR STEM CELL RESEARCH IS CONTROVERSIAL A second major obstacle to the development of new medical therapies based on stem cells is opposition to ESC research on ethical, moral, or religious grounds.
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From page 44... ...
Because in both of those belief systems there is a mandate to save human life wherever possible, human ESC research can be deemed acceptable if it is conducted reasonably and ethically (National Bioethics Advisory Commission, 1999~. In past Roman Catholic tradition, the Aristotelian view that life begins 40 days after conception was adopted by Augustine of Hippo and Thomas Aquinas and was maintained by the church for centuries.
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From page 45... ...
For those who hold the views that human life begins at conception and that the moral obligation to preserve human life outweighs any potential health benefits of ESC research for regenerative medicine, the only morally acceptable position would be to adopt a complete prohibition on human ESC research without regard to the method of embryo production or whether the research is publicly or privately funded. Views that require less than a complete prohibition, however, permit consideration of trade-offs in defining what is acceptable.
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From page 46... ...
It is, however, appropriate for the committee to reiterate a few key points to increase the focus and clarity of the various ethical debates. First, arguments in favor of imposing constraints or even an outright prohibition on ESC research are frequently supported by the assertion that research on stem cells from adult tissues alone will lead to the development of the sought-after medical therapies.
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From page 47... ...
, which is not generalizable to other cell types. It should also be noted that the study of human ESCs is likely to advance some applications of adult stem cells in the future.
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From page 48... ...
Fourth, it has been suggested that it is biologically preferable to derive stem cells from embryos created specifically for research rather than from surplus embryos at in vitro fertilization clinics, although both employ similar techniques in the initial stages. Several ideas underlie that suggestion.
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From page 49... ...
By comparison, basic research represented an average of only about 14 percent of aD private-sector pharmaceutical RED in the l990s, with pharmaceuticals representing the major area of concentration for private RED according to a recently completed National Research Council report on trends in support of research (NRC, 2001~. Although not-for-profit private entities, such as the Howard Hughes Medical Institute, also support basic research, privatesector efforts are dominated by for-profit companies that focus their research investments on product-related applications, such as new drugs, diagnostic tools, and medical devices that cure, detect, or prevent disease.
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From page 50... ...
She noted, however, that Geron, which provided the funding for the stem cell discoveries of James Thomson and John Gearhart, had stepped into the breach when public funding for embryonic stem cell research was unavailable. Importance of Multiple Avenues of Research A prohibition on federal funding of ESC research would limit progress not only by limiting funds, but also by limiting the number of scientists who participate in the research.
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From page 51... ...
Those institutions licensed the research widely at reasonable rates, and many analysts attribute the successful evolution of recombinant-DNA technology to those licensing arrangements. Arti Rai believes that the traditional academic focus on the importance of wide dissemination of fundamental knowledge has encouraged universities to shy away from exclusive licensing of the most fundamental research.
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From page 52... ...
It is important to note that many of the stem cell papers published to date, although heavily publicized by the mass media, have not yet passed the essential test of replication and scientific confirmation and must therefore be considered less than conclusive. Research Oversight The federal government in general and NIH in particular exert tremendous influence on the research that they fund through the mechanism by which they approve studies, the priorities they set, policymaking from informed-consent procedures to patent-seeking, and making the results of their research investments publicly available.
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From page 53... ...
Public funding would guarantee regulatory oversight for stem cell research, allowing, for example, a careful informed consent procedure for obtaining ESCs that is subject to public scrutiny. Peer review, as noted above, helps to ensure the quality of research proposals.
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From page 54... ...
In short, public funding engenders considerable opportunity for shaping the types of research that are approved. In general, privately funded investigators are subject to less oversight and review, although activities such as the pursuit of patents or marketing approvals from the Food and Drug Administration represent other mechanisms for oversight that are less relevant to basic research.
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