For years, American “stem-cell tourists” have flocked to unregulated clinics in Mexico, the Caribbean and China in search of everything from heart treatments to facelifts. But now, these kinds of clinics are popping up across the United States (The Washington Post, June 2016).

A case-in-point, but no less important is the Cell Surgical Network (CSN), which is promoting a major campaign for expansion, since in the last two years they have opened 42 centers offering cell therapy for 32 different conditions, using patients’ own stem cells.

Members of the CSN, which has expanded into 22 states, claim that their therapies involve minimal manipulation of tissue, which is obtained from the patients to be treated. However, these procedures are not regulated by the Food and Drug Administration (FDA), a federal body that monitors the marketing of new medical products.

Last year, Leigh Turner, an expert in Bioethics at the University of Minnesota, wrote to the FDA, urging them to investigate whether the CSN were violating laws regulating the possible administration of stem cells or products derived from them. Having received no answer, the investigator is promoting a campaign for experts in this area to pressure the FDA to regulate these therapies, to thereby try to prevent the US from becoming a provider of unregulated cell therapies to people from different countries. According to Paul Knoefler, a researcher at the University of California, there are now more than 100 clinics in the United States offering this type of therapy, although he thinks that this figure could be as high as 200.

Turner herself, in February 2012, wrote to the FDA, asking them to evaluate Celltex Therapeutics, a Texan company that worked together with South Korean companies offering cell therapies. As a result, the FDA inspected Celltex, confirming that this company only offers the possibility of processing these cells and creating cell banks with them, which does not preclude them from also sending them to independent doctors in Mexico, where these therapies are very poorly regulated. (Nature Medicine 20; 796-797, 2014).

Cell therapy clinics unregulated

Recently, Marc Scheineson, a former top FDA official who advises the Bipartisan Policy Center on medical innovation, said the current FDA regulatory regime is “archaic” and is stifling medical innovation(see HERE).

As we can see, even in a country as technology developed as the United States, legal regulation of some practices that are undoubtedly fraudulent is missing.


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