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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2 Responses to “Stem Cell Tourism”

  1. Jesse Reynolds says:

    This paragraph:

    “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.”

    implies that the U.S. is an outlier with respect to embryonic stem cell therapies and clinical trials. Just to be clear, there are neither valid embryonic stem cell therapies nor embryonic stem cell clinical trials anywhere in the world. Regarding the latter, the US is on track to host the first clinical trials. But given the high stakes, political polarization, and enormous attention given to such potential trials, everyone benefits if these proceed cautiously, not hastily. One merely needs to look at the case of medical gene transfer for a hyped, novel field that was greatly set back when a tragedy occurred, largely due to haste and lack of oversight.

  2. Michael Peroski says:

    Thank you for your comment. I should have made it explicitly clear that there are no ongoing clinical trials with human embryonic stem cells or efficacious therapies that use human embryonic stem cells. That said, it is worth emphasizing that the United States is lagging when it comes to embryonic stem cell research outside of the private sector.

    “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.”

    Indeed, the United States is on track for the first clinical trials. And I would agree and also add emphasis to your sentiments about exercising caution in approving the trials. Although the FDA has not yet indicated why it delayed the trials, I am willing to guess that it has to do with safety concerns. This is why I believe that evaluating policies on clinical application is especially pertinent. This means not only ensuring FDA regulation, but also ensuring that the studies receive IRB approval and oversight and also giving attention to the NAS and ISSCR guidelines for embryonic stem cell research and clinical translation. As in the case that you highlighted, even with all of these oversight mechanisms we can still have serious and tragic outcomes, so we need to be especially careful as this field is pioneered.

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