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).
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).
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).
None of the centers offered SCT based on embryonic cells.
Health information quality (JAMA score, measuring trustworthiness) was lowest for TCs and commercial websites and highest for scientific journals and health portals.45% of the centers specialized in treating 1 specialty, 10% offer 2, and 45% offered between 3 and 18 different specialties.Of the 78 TCs, 65% were in the USA, 23% in Asia, and 8% in Latin America.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.With recent scientific advancements, SCT is moving away from the ethical dilemmas surrounding the use of embryos, and toward the efficacy of treatments (Phinney and Prockop, 2007; Robinton and Daley, 2012; Trounson and Mc Donald, 2015).At present, SCs are routinely used as bone marrow transplantation, to treat hematological and immunological cancers and disorders, a practice that has existed for 50 years, and for longer than the term “SCT” been a research topic (Copelan, 2006; Appelbaum, 2007).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.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).