Stem Cell Tourism
With no stem cell therapies currently available in the United States, some citizens suffering from dehabilitating conditions turn to “stem cell tourism,” traveling abroad to receive stem cell-based treatments. Countries like the Dominican Republic and Malaysia lack the rigorous clinical standards set by federal policy in the U.S., and some U.S. researchers lament that without publication of studies from the labs abroad in peer-reviewed journals, and without strict clinical protocol, assessing the efficacy of these treatments proves difficult. Based on testimonials alone, the number of people receiving stem cell-based treatments means that policymakers must raise the bar for international researchers and clinicians and for further research in the U.S.
Some clinicians abroad use adult or umbilical cord stem cells. For example, thousands of people seek implants of umbilical cord stem cells at Xiaoshan Hospital in China. One group, EmCell, offers treatments for everything from aging to cancer using adult stem cells. Others offer more peculiar treatments, like the Bio-Cellular Research Organization, a Delaware-based company operating abroad, which touts its ability to treat patients with an injection of stem cells from fetal and newborn rabbits. Interestingly, many other U.S.-based companies offer stem cell treatments abroad.
As Kieran Breen, director of research and development at the Parkinson’s Disease Society in the United Kingdom explains, “there is no evidence whatsoever that these [therapies] work, and indeed they may be particularly harmful for people, with the potential for irreversible side effects.” To some who oppose human embryonic stem cell research in the U.S., a single adverse event resulting from a clinical application represents an opportunity to make a case against federal funding. But regulating these therapies abroad poses challenges. Ubaka Ogbogu, a research associate at the Health Law Institute at the University of Alberta elaborates, “it’s really difficult to deal with this from a policy standpoint, but that doesn’t mean we’re not going to try.”
Aside from highlighting the lack of therapies in the United States, this situation underscores a need to promote scientific progress in the U.S. through federal funding of embryonic stem cell research. As the FDA recently delayed approval of a private sector proposal for Phase I clinical trials of an embryonic stem cell therapy, the need to evaluate U.S. policies on clinical application of embryonic stem cells seems especially pertinent.
The International Society for Stem Cell Research unveiled its suggestion for clinical translation at its recent annual meeting. (Science Progress editor-in-chief Jonathan Moreno spoke at this event on legal and ethical considerations in human embryonic stem cell research). Another approach, suggested by Congresswoman Diana DeGette (D-CO), involves making the NIH the agency to formally ensure that the research proceeds ethically. As of now, labs voluntarily follow the National Academies of Science guidelines and the ISSCR protocol. Animal use committees, IRBs, and in the case of clinical trials, the FDA, all regulate current research. As embryonic stem cell research and clinical applications grow in the U.S., policy solutions will be necessary to handle cross-institutional collaboration, intellectual property issues, and the complexity of working with Embryonic Stem Cell Research Oversight committees.
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