A New Way to Bank
National Stem Cell Registry or Bank Can Facilitate Research
SOURCE: SP
Major innovations in the United States are often driven by collaborative research. Regenerative medicine is no different, and the federal government can help coordination.
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The following is an excerpt from a forthcoming Center for American Progress report on stem cell research.
Given recent research advances in regenerative medicine, ethical questions surrounding federally approved stem cell lines, and the likelihood that the next president may change existing rules for research, it’s time for some new thinking on stem cell policy.
In order to streamline research and improve research collaboration, the federal government needs to establish either a national stem cell registry and or a national stem cell bank for all human embryonic stem cell lines. A stem cell registry would be simply a database of all stem cell lines that are available to researchers through an organization such as the National Institutes of Health. The registry would contain all information about the cells, including the date and place of their procurement, the informed consent protocols used to obtain the embryos from which the cells originated, the biological makeup of the culture media used to nourish the cells, and the results of tests performed on the cells. A bank, on the other hand, would provide a central physical location where the cells could be stored so that a research organization could then distribute them to approved scientists who request them.
The National Stem Cell Bank contract expires in September 2009, and needs to be reconsidered, modified, extended, or terminated depending on the utility of the bank and the next administration’s stem cell policy.
Banks and registries are useful because they help to coordinate research and facilitate research collaboration. Indeed, major innovations in the United States are usually driven by research collaboration. A recent study from the Information Technology and Innovation Foundation found that over the past 35 years, America’s most economically significant innovations (as noted by the annual R&D 100 awarded by R&D Magazine) have more and more often come from federally funded research programs (from 14 percent of the top innovations in 1971 to 69 percent in 2006). Nevertheless, total federal levels of R&D spending have been decreasing in real terms since 2003 and the funding efforts for collaborative research have been limited. The report urges the federal government to improve the funding of research collaboration and for the federal government to rein in its decentralization of research funding, which it has recently been carrying to an “unproductive extreme.”
Currently, the NIH maintains a registry of the 21 approved stem cell lines. The NIH also contracts out the maintenance of the National Stem Cell Research Bank to the WiCell Research Institute at the University of Wisconsin-Madison, which was established through a $16 million, four-year contract in 2005. Currently, the bank contains 18 of the 21 lines (another line is held by the University of California, San Francisco and two others by the Swedish/British biotech company Cellartis). The National Stem Cell Bank contract expires in September 2009, and needs to be reconsidered, modified, extended, or terminated depending on the utility of the bank and the next administration’s stem cell policy. Ultimately, it remains the responsibility of Congress and the president to determine whether to continue or expand the national stem cell bank.
Difficulties may arise if federal funding of embryonic stem cell research suddenly opens up and unleashes a deluge of new hES cell lines for banking. Since the current business model has been unable to bank stem cells at economies of scale (at WiCell it cost $16 million to hold 18 lines for 4 years), the NIH and WiCell may not be able to get up to speed on cell banking in a cost-effective manner. We therefore suggest that the NIH explore multiple options and encourage competition among the many institutions across the country that store biological materials, including WiCell. The NIH can then arrange a new contract with the institution, or combination of institutions, that can maintain the most cost-effective bank.
The benefits of a stem cell registry are overwhelming, and even private entities that may be reluctant to bank their cells will still have clear incentives to register them.
Given the difficulty of getting a large and cost-effective stem cell bank up and running, the NIH should focus its initial efforts on expanding their existing stem cell registry and making sure that it is comprehensive. The NIH’s existing hESC registry sets a precedent for a national stem cell registry, but it is woefully incomprehensive. Not only must this registry be expanded to contain all cell lines for which federal funding is approved, the registry should also go beyond compiling the usual and rather basic information that it has maintained thus far. This expanded stem cell registry should be more sophisticated and offer information about the compatibility of lines with one another and with the laws governing embryo procurement in various states, locales, or institutions. This registry would optimize collaboration among research groups, as it would make voluntary registration very easy.
On June 20, 2007, President Bush attempted to expand the NIH’s stem cell registry by changing the name from the “Human Embryonic Stem Cell Registry” to the “Human Pluripotent Stem Cell Registry.” Nearly a year has passed and the NIH has still not settled on a definition of “pluripotent” that would set criteria for whether a given stem cell line would be allowed in the registry. Due to the failure of national-scale efforts like these, we recommend funding for projects intended to stimulate competition among private contractors in order to create a model for a sophisticated national stem cell registry which would then be developed specifically for the NIH.
The benefits of a stem cell registry are overwhelming, and even private entities that may be reluctant to bank their cells will still have clear incentives to register them. For example, listing stem cell lines enables more researchers (and hence potential customers) to know that the lines exist.
When it comes to stem cell banks, however, many for-profit companies may perceive challenges and be more resistant to banking their cells. For example, some for-profit owners of stem cell lines might not want to share their lines with every research group for reasons such as quality control, the amount of time it takes to deposit cells into a bank, and the expectation of payment. However, banking saves costs for companies by providing federally funded stem cell vetting comparisons of lines from multiple institutions. Banking also improves efficiency for researchers by centralizing research-quality stem cells, allowing for the easy scientific comparison of lines, and improving research collaboration. Ultimately, in spite of the initial difficulties that the NIH and other institutions might have in developing a cost-effective business model for stem cell banking, there would nevertheless be long-term payoffs.
Creating both a federally funded stem cell bank and registry would not be redundant, as the registry would catalog the bank’s lines, and the official registry of the bank would be the national registry. If the president and the Congress decide to continue funding and expand the national stem cell bank, it must be linked to the national registry. Carried out in a smart, efficient, and innovative manner, banks and registries will streamline research and foster collaboration by providing researchers with a uniform display of all available cell lines.
Michael Rugnetta is a Fellows Assistant at the Center for American Progress. Michael Peroski is an undergraduate majoring in biochemistry and philosophy at Allegheny College and a former bioethics intern with CAP.
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