DRW Monthly
April 2008
Issue No. 17

International Stem Cell Guidelines to be Drafted to Protect Patients

The International Society for Stem Cell Research (ISSCR) has formed a task force to develop guidelines to protect patients from the risks associated with participating in unproven stem cell treatments in overseas clinics, such as those being conducted in China, Costa Rica and Barbados. Although embryonic stem cell and related cell therapy experiments have shown promise in Petri dishes and animals, only a handful of cell implantations have been performed in human patients. Researchers and regulators recognize the potential of these therapies, however, they are also very concerned about how to test these treatments and how much risk should be tolerated in humans. The same cells that can form dozens of different tissues in the body to repair diseases and injuries are also genetically programmed to easily divide and grow, thereby causing tumors to develop. Other unanswered questions linked to these therapies concern how the cells will travel through the body and whether patients will need to take immune-suppressing drugs for these treatments to work.

In the past few years, desperate patients and their families have increasingly pursued costly treatments that have no scientific or clinical basis. Scientists are concerned that serious side effects or injuries suffered by patients as a result of these unregulated stem cell treatments may discredit the field of legitimate stem cell research and impede scientific advances. More recently, FDA's Cellular, Tissue, and Gene Therapies Advisory Committee has been wrestling with how much substantiation to require researchers to demonstrate in animals before it allows these experiments to be run in human clinical trials. At this stage, the conclusion the agency has reached is that patients receiving stem cell treatments will need to be monitored forever.(1)

On a separate but related note, it is interesting to observe the shift in ethical priorities among stem cell researchers over the past few years. While the guidelines currently being drafted emphasize patient protection for those undergoing stem cell therapy, the ISSCR guidelines developed in 2006 center on establishing uniform human embryonic stem cell research practices so that scientists worldwide can operate under a single, transparent code of practice. The ISSCR's Guidelines for the Conduct of Human Embryonic Stem Cell Research outlines permissible and impermissible experiments, including sample consent form and material transfer agreement documentation, and generally speaking, focuses on "issues unique to stem cell research that involves pre-implantation stages of human development, research on the derivation or use of human pluripotent stem cell lines, and on the range of experiments whereby such cells might be incorporated into animal hosts."(2) The present ISSCR task force, by comparison, which includes about 30 scientists, investors and government officials, is completely focused on how to better coordinate the accelerating pace of global stem cell research while simultaneously protecting patients participating in these medical treatments. It is hoped that the task force will complete a draft of these guidelines by the end of the year so that they may provide the global research community with a uniform standard for safe and effective clinical practices in stem cell treatment.


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