The last 10 years has brought about the development – and broader acceptance – of cellular therapies. But, as with many great breakthroughs, there’s a dark side – the selling of unproven cell therapies. Unfortunately, unscrupulous people are bold enough to take advantage of desperate patients, and there are countless clinics worldwide advertising cell therapies to treat a range of diseases including cancer, Alzheimer’s, Parkinson’s and more. A current core focus of the International Society for Cellular Therapy (ISCT) is to combat medical tourism and tighten up loose legislation.
The regulatory climate in the US suffers from loopholes that complicate the issue, specifically the fact that “minimally manipulated” cells are subject to different rules compared with conventional cell therapies. According to the legislation – under section 361 of the Public Health Service Act – minimal manipulation means cells have not been chemically or biologically altered. For example, if a patient has a tissue sample removed and simply centrifuged to separate the components, it is considered minimal manipulation (despite potentially fundamental changes) – and the resulting cells are not subject to any other regulations. As such, it is currently legal in the US to isolate a patient’s own cells and inject them back into their body, without the need for extensive testing. Indeed, you may recall the ocular injection incident in Florida earlier in 2017; three patients paid at least $5000 each for an unapproved cell therapy that involved injection of autologous fat cell-derived stem cells into their eyes in an attempt to treat macular degeneration. Two of the patients lost most of their eyesight and one patient was left completely blind by the procedure (1). Such lax regulation is in complete contrast to section 351 cell therapies that are “meaningfully manipulated” – here, regulations are extensive; there are requirements for safety and efficacy tests, and the need for market authorization from the FDA along with an Investigational New Drug (IND) license to conduct research or commercialize the therapy. To protect patients, the ISCT is trying to work with legislative and regulatory agencies to close these cell therapy loopholes. But it’s a long and tricky process – and even legislators can be convinced of the benefits of bogus unproven therapies by particularly talented sales people with “snake oil” pitches... In particular, the ISCT would like the United States Justice Department to play a larger and more visible role in setting these regulations; after all, it is a matter of public health and safety.
The ISCT is also taking a parallel route to address the issue from a patient perspective. People in desperate situations can make irrational judgments. And although we can’t put ourselves in their shoes or tell patients or their families what to do, we can try to provide them with as much information as possible and make them aware of the potential dangers and lack of proven efficacy of unapproved treatments so they are able to make the best possible decisions. To that end, the ISCT has been reaching out to professional societies, creating patient education sheets and web statements, and using social media and other online resources. In 2015, for example, the ISCT published a reference guide on the use of unproven cellular therapies (2). In fact, we’re doing everything we can think of to get the message out there to make sure patients are as informed as possible before making any major health-related decisions. Some people wrongly perceive stem cell therapy as a magic cureall – and there are individuals out there who take advantage of that. Aside from the obvious aforementioned risk to patients, it also jeopardizes the future of the field. If unapproved cell therapies are allowed to exist without proper regulation, it could result in a stigma around the field, which could affect legitimate research – or possibly stop legitimate cell therapies from reaching patients. If we truly want to help patients and allow the cell therapy field to proliferate, we need to act now and properly regulate unapproved treatments.
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References
- AE Kuriyan et al., “Vision loss after intravitreal injection of autologous ‘stem cells’ for AMD”, New Engl J Med, 376, 1047–1053 (2017).
- ISCT, “ISCT Presidential Task Force on the Use of Unproven Cellular Therapies: Reference Guide,” (2015). Available at http://bit.ly/1VT1xay. Last accessed July 26, 2017.
