Advanced Cell Technology (www.advancedcell.com) has been active in the hESC field since the first isolation of an hESC line in 1998. “Given the rapid developments in human embryonic stem cell work over the last several years, Advanced Cell Technology is in the best position to transform basic research into tangible, practical techniques in regenerative medicine,” asserts chairman and CEO William M. Caldwell, IV. “To succeed, the California initiative must allocate a sizable portion of their funding to the translation of science into therapies. That is what the voters expected when they approved funding for stem cell research.”
Federal government guidelines have imposed severe restrictions on hESC experimentation. The NIH has limited the number of available cell lines it will fund to 71 individual blastocysts discovered by scientists in the U.S., Australia, India, Israel, and Sweden. The U.S. government as well as many Americans object on moral and religious grounds to stem cell research that involves the purposeful destruction of human embryos. Recently, President Bush vetoed a bill that would have increased the number of cell lines permitted by Federal funding to approximately 400. State governments and private funding sources are free to use whatever cell lines they believe will be the most promising.
“While CIRM and similar programs in New York, New Jersey, Massachusetts, and other states will help jump-start the stem cell industry, the way they do so is quite inefficient,” Caldwell says. “Each state funding source has or will develop its own bureaucracy, rules, regulations, and restrictions, in many cases duplicating the infrastructure of a neighboring state. Moreover stem cell research is not bound by state lines. Funding entities need to encourage collaboration between research groups, regardless of their state of domicile. And perhaps most importantly, they need to recognize the tremendous advancements made by for-profit companies.”
For these reasons, Caldwell believes that the proper funding source for hESC research should be centralized, preferably at the NIH. In July, 2006, in a paper published in Nature, Advanced Cell said it had perfected a technique that created stem cell lines from single cells taken from a very early-stage embryo. The cell-harvesting method, which does not harm the embryo in any way, has been the basis for several years of preimplantation genetic diagnosis (PGD). This test is routinely performed on embryos used for in vitro fertilization. More than two thousand healthy children are alive today in the U.S. after undergoing PGD at the embryonic stage. “We believe that our cell harvesting technique eliminates moral concerns about embryo destruction,” notes Caldwell.
Despite the uncertain nature of government funding for stem cell research, the prevailing trends are encouraging. Even with severe federal restrictions, companies with advanced hESC technologies are doing their best to work around granting limitations. In 2006, Advanced Cell received a $200,000 grant from the NIH for an ongoing stem cell project with the Burnham Institute of Medical Research. This research will focus on stem cell lines for treating diseases of the heart, skin, and vascular system.
The approach leverages Advanced Cell’s expertise in stem cell biology and phage display along with Burnham’s expertise in developmental biology involving the use of phage-displayed ligands to probe for chemical signals that cause hESCs to differentiate. Phage display exploits the ability to create libraries of proteins on the surfaces of bacteria-infecting viruses.
The two organizations recently identified a family of cell-targeting peptides that bind early-differentiating hESCs. Researchers use these cell-targeted peptides to track the developmental fate of cells, which will allow identification of precursors of important specialized cells.