Today the International Society for Stem Cell Research (www.isscr.org) is releasing “Guidelines for the Clinical Translation of Stem Cells,” which co-chair of the ISSCR task force, Olle Lindvall, MD, PhD, calls a “roadmap.” The long-awaited report condemns websites that hawk bogus stem cell therapies to the desperately ill.
I chanced upon these websites shortly after my friend and hospice patient Glenn lost his battle with ALS last March. One company, for example, offers a costly brew of mashed up embryos and promises, not even knowing what a human ES cell actually is. (see “The gap between science and society widens on stem cells,” blog.bioethics.net, 4/13/08).
Dr. Lindvall, who heads the Laboratory of Neurogenesis and Cell Therapy at Lund University Hospital in Sweden, was kind enough to tell me about his ALS patients. “For them, no cell therapy at the moment has any chance of success. As a human being and a physician, I understand that patients and their relatives want to do anything possible. But I must also be honest. I inform them that there is nothing I can offer. Even if something had the slightest chance of success, we would offer it, but that is not the situation.”
I hope that the ISSCR guidelines will quench the flames of false hope until stem cell science can legitimately catch up with expectations – which it will. The roadmap may perhaps be most helpful by pointing out the long trajectory for novel treatments, which illuminates precisely what is missing in the snake oil Internet ads: evidence. “Researchers must go through quite a long process to show efficacy in an animal model in order to propose a clinical trial. Without any evidence that a therapy can work, it is unacceptable to offer it to patients, and especially to charge them,” says Dr. Lindvall.
The ISSCR guidelines also call for:
Members who have “stem-cell-specific expertise” be on committees that address human subjects in stem cell research.
Systematic assessment of the integrity and potency of stem cell products.
Informed consent for volunteers in clinical trials that addresses risks (cancer, immune reaction, unexpected effects, unknown long-term health effects, and the vague “sensitivities surrounding the source of cellular products”).
Reporting of all trial results to assure transparency.
Exceptions so that small numbers of patients without hope and for whom a specific stem cell intervention makes sense can be treated.
In the future, fair access to stem cell based treatments.
A summary is at www.cellstemcell.com/
Dr. Lindvall wasn’t all gloom and doom. “For the first time there is hope for radical new therapies, but we also have to move the research to the clinic responsibly.” And he’s very excited about the role that the U.S. will play in the future. “The task force has members from 13 countries. Stem cell research is not from a European perspective, or an American perspective. It is international. To move the field forward, US scientists and clinicians will be extremely valuable.”
As George W. Bush’s proclamation from August 9, 2001 restricting federal funding for stem cell research fades into history, that’s really nice to hear.
Ricki Lewis, PhD
Ricki Lewis is the author of Stem Cell Symphony (www.stemcellsymphony.com), Stem Cells Come of Age (www.InsightPharmaReports.com), and the textbook Human Genetics: Concepts and Applications. She is a fellow of the Alden March Bioethics Institute and can be reached at ralewis@nycap.rr.com