MADISON -- In an effort to move human embryonic stem cell technology into the mainstream of academic and corporate research, the Wisconsin Alumni Research Foundation has established a private subsidiary whose primary purpose will be to distribute the cells to qualified scientists.
Embryonic stem cell lines were first successfully established late in 1998 by a team of scientists from the University of Wisconsin-Madison. The patents that govern the technology and use of the cells are held exclusively by WARF, a private not-for-profit corporation that manages intellectual property in the interest of the university.
Stem cells are the parent cells of all cells in the body. An ability to grow the cells in the laboratory and, someday, to direct them to become specific kinds of cells -- blood cells, muscle cells, or brain cells -- has the potential to revolutionize transplant medicine and underpin lifelong treatment for a host of debilitating diseases, especially cell-based disorders such as diabetes mellitus, Parkinson's disease and some forms of leukemia.
The primary mission of the new non-profit institute, to be known as WiCell Research Institute, Inc., will be "to supply cells to support research for both academic and non-academic researchers," according to Carl Gulbrandsen, WARF's managing director.
The institute's scientific director will be James Thomson, the UW-Madison developmental biologist in whose laboratory human embryonic stem cells were first isolated. Thomson will remain on the Wisconsin faculty, however.
"Our intention is to make these cells widely available, and at a low cost for academic researchers," Gulbrandsen says.
So far, more than 100 requests for the cells have been received by Thomson's lab and at least a dozen companies have approached WARF about stem cell technology.
However, many scientists, especially academic scientists who depend on federal support to operate their laboratories, have been waiting for the National Institutes of Health (NIH) to finalize a set of guidelines for use of the cells. Those guidelines, after nearly a year of formulation and deliberation, were made public by NIH late last year and, when implemented, are expected to greatly accelerate demand for the cells as they would permit the use of federal money for the first time to conduct human stem cell-related research.
In addition to the promise of widespread clinical application, the cells hold the potential for developing powerful new drug discovery schemes. Biologists think, too, that the cells could lend new insight into the now largely unknown early stages of human development, knowledge that could spur new treatments for infertility, birth defects and help prevent pregnancy loss.
However, if the promise of stem cell technology is to be fulfilled, Thomson says, it is essential that the cells be made readily available to the broad scientific community: "The important thing is now we can distribute the cells to as many scientists as want them," he says.
By making human embryonic stem cells widely available to researchers in both corporate and academic laboratories, some of the technical roadblocks to full development of the technology can be attacked, Thomson says. For example, while stem cells in culture have been observed to differentiate into the complete array of human cells, scientists do not yet know how to specifically direct them to form pure populations of desired cell types.
Virginia Hinshaw, dean of the UW-Madison Graduate School and the university's senior research officer, is a member of the new institute's board of directors. She says that the establishment of the WiCell Research Institute will strengthen the ability of others to work with the cells and advance a technology that, despite its great promise, has been limited to an exclusive handful of laboratories, mostly in the U.S. and Europe. Until final implementation of the new NIH guidelines occurs, any laboratory that receives federal support is prohibited from working with the cells.
The information gained from growing these cells and studying them is necessary to move a technology with huge potential from the laboratory to the clinic, Hinshaw says: "Now we can develop a greater and greater data bank of knowledge about these cells and all of us will gain from that."
Scientists interested in using the Wisconsin cells must sign a licensing agreement that includes some restrictions on the use of the cells, Gulbrandsen says. For example, use of the experimental cells for cloning or intermingling with intact embryos will not be permitted.
Founded in 1925, the Wisconsin Alumni Research Foundation is the oldest and one of the most successful of all university intellectual property organizations. Through the management of a large intellectual property portfolio and the investment of royalties and licensing fees, WARF has created an endowment that returns on the order of $20 million annually to UW-Madison for unrestricted use in research and education.
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