Correspondence


Nature Biotechnology 27, 21 - 22 (2009)
doi:10.1038/nbt0109-21b

Stem cell transplants: the power of peer-to-peer

Graham Creasy1 & Christopher Thomas Scott2

  1. Stanford Spinal Cord Injury and Repair Program, R281, 300 Pasteur Drive, Stanford, California 94305-5327, USA.
  2. Stanford University Center for Biomedical Ethics, 701 Welch Road, Building A, Suite 1105, Palo Alto, California 94304, USA. e-mail: cscott@stanford.edu

To the Editor:

Your September editorial1 discussed how patients use information technology and the Internet to form online communities. Increasingly, these portals are used to exchange information and discuss treatment options in ways that are potentially powerful and disruptive to conventional models of healthcare, education and research.

A particularly sensitive application of this technology has arisen as patients pursue potential applications of stem cells to chronic, disabling or terminal conditions. Although there is widespread interest in the curative power of pluripotent cells, there are few clinical applications or approved clinical trials using stem cells in industrialized countries for scientific, medical, ethical, legal and political reasons. Individuals with incurable conditions, finding information on the Internet about interventions in other countries, are attracted by promises of benefit and even cure. Acting out of determination and sometimes desperation, they travel in increasing numbers for stem cell transplants, usually at considerable personal cost. The stakes are high; the prospects of benefit must be weighed against the medical risks and financial outlay, often with only anecdotal information to guide the decisions. This provokes important questions about how these experiments in free will might be managed and what might be learned from them.

The phenomenon of 'stem cell tourism' seems unlikely to subside in the short term. As such, we argue there is an ethical duty to provide individuals who are considering such options with the best available information about the risks and benefits of the procedures. Even so, in most cases a dearth of scientific and medical information exists on the specific 'treatments' being offered. Acquiring as much such information as we can about the interventions and their consequences—beneficial, harmful or inconclusive—leads to better healthcare decisions by patients, caregivers and clinicians. If there are benefits, we want to know. If there is harm, we need to know. If there are no effects, we still need to know so that patients can conserve their energy and funds until more effective applications become available.

The best way to produce reliable information is through controlled clinical trials, which are subject to the rigors of peer review. But without a trial, at a minimum it would be useful to obtain objective data about the consequences of these stem cell transplants by careful evaluation of patients before and after the procedures and by documenting confounding factors and co-variables. Regardless of the transplant, reliable data about any significant changes would be of value and might serve as pilot data for more rigorous trials in the future. In the field of spinal cord injury—a well-publicized target for stem cell treatments—there is considerable interest in defining better outcome measures to evaluate changes in impairment and function, not only of paralyzed limbs but also of bladder, bowel and sexual function and other physiological and psychological parameters that may affect quality of life.

We would like to alert readers to the Spinal Cord Outcomes Partnership Endeavor (http://scope-sci.org/), an international collaboration between academic, medical, government, industrial and consumer organizations to develop improved clinical trial and clinical practice protocols and define reliable, accurate, sensitive and specific measures of clinically meaningful outcomes. The Stanford Spinal Cord Injury and Repair Program is pursuing an initiative to apply some of these assessments to patients who have decided to pursue stem cell interventions overseas. Agreement on outcome measures would allow collaboration on such an initiative by multiple research groups in different countries, pooling data to increase the likelihood of statistical significance and early conclusions. Such a project would also provide the opportunity to inform patients about risks and benefits, at least in general terms, and to educate them about the types of questions that would be reasonable to ask of any clinic offering novel treatments. An example of guidelines about experimental treatments for spinal cord injuries is available on the website of the International Collaboration on Repair Discoveries (http://www.icord.org), in association with the International Campaign for Cures of spinal cord injury paralysis (http://www.campaignforcure.org/iccp).

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Because of the controversial nature of some stem cell transplants, it is critical to design these studies with careful attention to ethical issues. These include scientific impartiality and the avoidance of implied endorsement or disapproval of unproved treatments. There may be a duty to warn of known fraud, especially risky procedures, or patient abuse. A distinction should be drawn between the informed consent to an intervention and the informed consent to evaluate the intervention. These processes must be separate, even if the clinicians doing the evaluation cannot be truly blinded to the intervention. Other ethical questions emerge, too. At what point should there be contact between the evaluators and providers of transplants? Should governments get involved? If so, how do we reconcile the ethical norms of one country with another?

Patients who pursue unconventional and untested transplants usually find clinics and health information using a variety of peer-to-peer channels. Some websites are sponsored by patient community and advocacy organizations such as PatientsLikeMe (http://www.patientslikeme.com). Sites, like MySpace and personal blogs, link other patients. And, some are managed and paid for by for-profit stem cell providers. Information across channels can range from accurate to misleading and possibly dangerous. No one can deny the power of the Internet to enable patient-driven healthcare. It is our view that engaging reliable peer-to-peer networks early and often can uncover misinformation, provide some real-time results and aid in the logistical dimensions of observational studies like ours. It is necessary for clinicians and researchers to work more closely with advocacy organizations and patient networks to provide information about these evaluations, to educate patients about their healthcare options, and in the process, educate ourselves about new models of providing clinical care, education and research.



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Reference

  1. Anonymous. Nat. Biotechnol. 26, 971 (2008).