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The description of tier two treatments stipulates that SCs “…
This is in part due to increased numbers of negative media stories emerging of desperate patients undergoing costly SCT abroad only to go onto develop complications (Berkowitz et al., 2016; Kolata, 2016).
However, more recently, there has been a proliferation of TC closer to home, and the USA is now a major center for TCs offering therapies.
Both the FDA and EMA have issued public and industry guidance recommending that any SCT undertaken should be explicitly approved, or as part of a clinical trial that has been allowed to proceed by the authorities (FDA, 2012; EMA, 2013).
In addition, institutional organizations such as The International Society for Stem Cell Research (ISSCR) have produced their own information and recommendations patient handbook (ISSCR, 2017).
Most websites returned were from treatment centers (TCs, 44%) followed by news and medical professional websites.
The specialty most mentioned in non-TC websites was “neurological” (67%), followed by “cardiovascular” (42%), while the most frequent indication for which SCT is offered by TCs was musculoskeletal (89%) followed by neurological (47%).Similarly, in Europe, SCs are only viewed by the EMA as a drug if they are unmodified cells used for a biologically different function, or modified cells that have been substantially manipulated (including expansion) (Martìn et al., 2014).Cells that require manipulation (e.g., expansion) are legally treated as medicines, rather than transplants, by both the EMA and FDA meaning they have to pass rigorous regulatory requirements (Bianco et al., 2013a).There are expectations that stem cell therapy (SCT) will treat many currently untreatable diseases.The Internet is widely used by patients seeking information about new treatments, and hence, analyzing websites is a representative sample of the information available to the public.TCs around the world offer treatments for an array of conditions (Lau et al., 2008; Turner and Knoepfler, 2016), with variable levels of evidence, while the majority are not performing these therapies as part of a credible clinical trial (George, 2011).The Internet is a major resource for information-seeking patients who can find information from different sources.The only other SC-related treatment that is currently approved by the U. Food & Drug Administration (FDA) is an umbilical cord blood derived product produced by the New York Blood Center and used for specific hematological conditions (FDA, 2012).The European Medicines Agency (EMA) approved its first SCT treatment in 2015 for the use of a corneal SC based therapy for treating corneal diseases (EMA, 2015).A recent study found 351 companies operating 570 TCs in the USA (Turner and Knoepfler, 2016), while there is some evidence of similar practices in Europe (Bianco et al., 2013a).In some cases, these TCs operate in a “gray area” in regulations.