Research Paper On Stem Cell Therapy

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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.

Analyzing the information available on the web can give an idea of how people develop their understanding and knowledge of health-related issues, such as vaccination or supplements (Maki et al., 2015; Aslam et al., 2017).

We have used an approach used in other similar studies to analyze the information on SCT that is available on the Internet (Maki et al., 2015; Aslam et al., 2017).

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).A number of criteria and instruments have been devised to assess health information quality, such as the JAMA score (whether the website shows the main transparency indicators: author, date, references, and ownership) (Silberg et al., 1997) or the presence of the health-on-the-net (HON) code seal, which is provided by a not-for-profit organization, the HON foundation (Boyer et al., 1998).While most of the studies on health information online focus on quality, in reference to patients seeking specific information on a condition (Chumber et al., 2015; Yaqub and Ghezzi, 2015; Bizzi et al., 2017), the Internet also plays a major role in the diffusion of beliefs.The description of tier two treatments stipulates that SCs “…that are, minimally manipulated, labeled or advertised for homologous use only, and not combined with a drug or device,” are subject to reduced oversight and FDA approval requirements (Parson, 2006).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).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.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).

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