The new guidelines are meant to guide research toward what is practical and responsible, Hyun said. Previous scientific guidelines and regulations have regulated human-subjects research and clinical research in general, as well as gene transfer research, but not stem cell research, which poses a number of independent issues.
"Most of the time, stem cell products are presenting entirely novel products that are unpredictable in humans," Hyun said. "Unlike drugs, you can't just create a batch and put them on the shelf and expect they will be the same. We need uniform quality control and manufacturing. And if they're embryonic or pluripotent stem cells, they could form unwanted tissues or tumors. So, we have to be very careful about following up and monitoring patients."
Accordingly, the guidelines, written by a task force of stem cell specialists from 13 countries, addressed issues of ethical review, quality and safety of the stem cells; voluntary informed consent of participants in research projects along with careful monitoring of these volunteers and caution in using stem-cell-based therapies outside a research context.
Despite its promise, stem-cell based treatment is the standard of care for only a few diseases and conditions. These include hematopoietic stem cell transplants for leukemia and epithelial-stem-cell-based treatments for burns and corneal (eye) disorders.
Still, the potential of stem cell research is vast, experts said. Although research has not yet translated directly into abundant therapies for patients, the gains have been substantial, albeit indirect.
"For patients, it's not surprising that there are not direct applications, but what is often lost to public is that so much knowledge had been gained from stem cell research," Hyun said. "The advancements for patients are going to come sooner through these indirect routes, not direct cell-based therapy, from the expansion of knowledge."
There's a patient handbook on the new guidelines at the International Society for Stem Cell Research.
SOURCS: Insoo Hyun, Ph.D., associate professor, bioethics, Case Western Reserve University School of Medicine, Cleveland; Paul Sanberg, distinguished professor, neurosurgery, and director, University of South Florida Center for Aging and Brain Repair, Tampa; Darwin J. Prockop, M.D., director and the Stearman Chair in Genomic Medicine, Texas A&M Health Science Center College of Medicine Institute for Regenerative Medicine at Scott & White, Temple; December 2008, Cell Stem Cell