Research Paper On Stem Cell Therapy

Research Paper On Stem Cell Therapy-9
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.

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.

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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.

FDA guidelines are organized in a three-tier structure for deciding on the level of treatment oversight required (Chirba and Garfield, 2011).

The first tier covers non-manipulated SC transplants such as bone marrow; the second tier refers to “minimally manipulated,” “homologous” SCs; and the third tier refers to “more than minimally manipulated,” “non-homologous” SCs, such as embryonic SC (ESC) or induced pluripotent SC (i PS).

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).

This study shows a disconnection between information about SCT and what is actually offered by TCs.

The study also shows that TCs, potentially acting in a regulatory gray area, have a high visibility on the Internet.

The aforementioned subclause is stated commonly by TCs and is considered to be legal authorization to treat with minimally manipulated SCs outside of a clinical trial protocol.

In cases where TCs wish to offer treatments with cultured SCs, which have been expanded in the laboratory, the clause no longer applies, and the TC either has to operate according to approved clinical trial protocols (George, 2011), or to perform the procedure outside of the USA/European oversight.

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