By Lisa Monique Thompson
In October 2007, the second annual Stem Cell Summit was held in Boston. The Summit, produced by the Harvard Stem Cell Institute, the Genetics Policy Institute, and the Burrill Life Sciences Media Group, gathered many great scientific minds, as well as ardent advocates, in the field of global stem cell research.
There was a combined feeling of hope and frustration from researchers, patient advocates and patients themselves. Patients and patient advocates decried what seems to be an interminable wait for U.S. research teams to catch up with international clinical trials. U.S. scientists cited a severe lack of funding combined with a lack of donated eggs to perform somatic cell nuclear transfer research (sometimes called “therapeutic cloning” research — see sidebar).
California, Massachusetts, and Missouri all have legislation supporting stem cell research. This does not mean that stem cell research in those states is safe. In fact, some legislators in Missouri are looking to ban and criminalize SCNT by revoking an amendment that currently allows for stem cell research and therapy as allowed by federal law. Catch phrases such as “Dolly [the sheep cloned in Scotland], daughters, and dollars” are prevalent and prey on people’s fear of human cloning and convolute the issue. Moreover, legislators are in most cases scientific laypeople who have great difficulty understanding this complex science.
Stem cell advocates were encouraged to look to California, Massachusetts, and Missouri, as well as countries like Belgium, Great Britain, Israel, Japan, Spain, and Sweden, as models of appropriate legislation. William Neaves, President and Chief Executive Officer of the Stowers Institute for Medical Research, warned Summit attendees that this “Cures without Cloning” move in Missouri is simply and frighteningly a test case for other states.
Ian Wilmut, the famed University of Edinburgh embryologist, who is best known as the man who supervised the individuals that cloned Dolly the sheep, noted that SCNT offers more promise to produce cells equivalent to those in the patient because in SCNT, donor cells can actually be taken from the individual. The cells then harvested are patient-specific and may eliminate concern of transplant immune rejection. Rudolf Jaenisch of MIT’s Whitehead Institute for Biomedical Research agreed about the promise of SCNT, but reiterated that embryonic stem cell research is the standard for producing pluripotent cells because of practical applications.
John McDonald, Director of Kennedy Krieger Institute’s International Center for Spinal Cord Injury, believes that “combined therapies can lead to spontaneous recovery and the improved physical health of the patient.” He said scientists need to understand pragmatic goals, such as the return of sensation. By focusing on these pragmatic cures, he added, researchers would be more drawn to a field typically plagued by a lack of observable results.
This, combined with the polemical political environment, has left U.S. researchers lagging behind their international counterparts as desperate patients abandon the United States for the hope of therapies abroad. Jack Kessler of the Feinburg School of Medicine at Northwestern University cautions that there are major concerns of only a limited number of clinical trial attempts in the United States due to funding, patient population problems (such as complete versus incomplete spinal cord injury, etc.), the variety of cells that must be repaired or replaced in order to restore function, and the body’s natural immune response. Feinberg said U.S. researchers must therefore avoid premature clinical trials until sufficient restoration of function is demonstrated in existing animal models and bridge that to human ones because “if we pick the wrong patients and fail, we’ll lose all our momentum.”
Barriers and Advances
With little doubt, the polemical political environment is the biggest barrier to stem cell research in the United States. After two presidential vetoes of the Stem Cell Research Enhancement Act, the Democratic Congress has been unable to reverse or even temper the Bush Administration’s initial stem cell funding and research restrictions. According to Dr. Wise Young, Department of Cell Biology & Neuroscience in the W. M. Keck Center for Collaborative Neuroscience at Rutgers, the National Institutes of Health still spends only $250 million — less than 1 percent of NIH’s $28 billion total budget — on human stem cells. This is less than the annual $300 million spent by the state of California alone.
Dr. Kim Anderson, of California’s Reeve-Irvine Research Center’s Department of Neurological Surgery, who has a spinal cord injury herself, said, “The biggest barriers are the political restrictions, which then create monetary restrictions. I’ve seen the changes in California due to Proposition 71, and now that the money is flowing, the potential is much more tangible.” She also agrees that stem cells will eventually provide potential therapies for many diseases, notwithstanding all that still must be learned about them.
While California’s Proposition 71 made stem cell research a constitutional state right and allocated $3 billion over 10 years for research, similar legislation for state funding in New Jersey was quashed in November 2007. Young believes that complacency on the part of advocates led to the defeat of the New Jersey referendum. Many stem cell advocates are content in the hope that the 2008 presidential elections will cause a political paradigm shift in NIH funding. As a result, Young noted, “We were outspent, outmaneuvered, and consequently outvoted.” He points out that what advocates fail to realize is that even if immediate changes are made to stem cell legislation and funding after the next presidential election, budgeting limitations may continue for many years.
However, even with little funding, scientists are finding a way. In November 2007, Shoukhrat Mitalipov of the Oregon National Primate Research Centre announced he had produced stem cells using primate skin cells. The resultant stem cells were then used to produce a variety of other cell types, including heart cells. Only a week later, researchers in both Japan and at the University of Wisconsin announced they were able to reprogram human skin cells to become stem cells. The excitement over this discovery is evident in the plethora of articles and blogs claiming embryonic stem cells are no longer necessary if skin cells can be used for research. Most scientists, however, think this is far from true.
PBS recently interviewed Dr. Hans Keirstead, a preeminent embryonic stem cell researcher from the UCI Reeve-Irvine Center about these skin cell reversion breakthroughs. “I’m very optimistic for researchers, less so for clinicians. This breakthrough by the American and the Japanese groups reverting a skin cell to a stem cell makes for a new tool, a new source of stem cells. They are not amenable to use in humans. They have a greater propensity to form cancers for instance, but they’re a fabulous research tool.”
Even so, Keirstead expresses an absolute excitement about the real possibility of finding a cure for spinal cord injury through embryonic stem cell research. “I’m extremely optimistic about what I’m doing … it’s not a matter of if, it’s a matter of when … it’s a matter of financing.”
Rudolf Jaenisch of MIT, with his colleagues at the Whitehead Institute for Biomedical Research, was able to take a mouse’s skin cells and revert them to an embryonic-like state. Like Keirstead, he too cautioned that this new discovery in skin cells should not undermine the continued research of embryonic stem cells.
The second annual Stem Cell Summit brought together the most ardent researchers, patient and patient advocates, hospital and biotech firm administrators, and venture capitalists. From the viewpoint at the Summit, individuals should be cautiously optimistic about the progress of this science. However, major scientific leaps have been made just recently, and several groups are in the preliminary stages of clinical trials, including those of Drs. Ed Wirth with Geron in California, Hans Keirstead, Stephen Davies in Denver, and Wise Young in China. Once success in clinical trials becomes reproducible, these stem cells can be developed into a modality for treatment. Soon after, the venture capitalists, and their money, will follow.
Until then, researchers implore advocates to help them raise the money necessary to continue both adult and embryonic stem cell research. Stem cell research will enable scientists to unravel the mysteries of disease, but it is embryonic stem cell research that will likely cure it.
Where to find more information:
* Biotechnology Industry Organization — www.bio.org
* Coalition for the Advancement of Medical Research — www.camradvocacy.org
* Daniel Heumann Fund for Spinal Cord Research — www.heumannfund.org
* Genetics Policy Institute — www.genpol.org
* Hadassah — www.hadassah.org
* Harvard Stem Cell Institute — www.hsci.harvard.edu
* Heumannly Capable — www.heumannlycapable.com
* International Center for Spinal Cord Injury at Kennedy Krieger Institute — www.kennedykrieger.org
* Reeve-Irvine Research Center — www.reeve.uci.edu
* Sabrina Cohen Foundation for Stem Cell Research — www.sabrinacohenfoundation.org
* The Stem Cell Summit — www.thestemcellsummit.com
* The Stowers Institute for Medical Research — www.stowers-institute.org
* Whitehead Institute for Biomedical Research — www.wi.mit.edu
* Whyte Hirschboeck Dudek Government Affairs — www.whdlaw.com