Stem Cell Processing (Stem Cells in Clinical Applications)

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1.2.2.4 Clinical Use


The translation of stem cell research has raised further ethical issues of which the
most prominent is the patient’s exposure to health safety risks. Inherent risks of
stem cell treatments include risks related to stem cells differentiating into undesir-
able tissue types, such as tumorous tissue and the transmission of viruses or pollut-
ants which can cause secondary disease (Prockop and Olson 2007 ).


1.2.3 Impact on Societal Perceptions

Patients may experience frustration at not being able to access potentially effective
stem cell treatments, but at the same time governments are obligated to protect their
nationals from unproven, ineffective, and possibly dangerous treatments and fraud-
ulent advertising in this regard. An analysis of patients’ online blogging reveals that
patients often visit dubious stem cell clinics for therapeutic purposes because they
feel that they have no other choice and that they cannot afford to wait for stem cell
treatments to be approved through traditional regulatory processes (Ryan et al.
2010 ). A great concern is the lack of information given to patients regarding the
reason for the existence of regulatory processes or the value thereof (Master et al.
2013 ). A proactive approach to the education of patients and innovative methods of
communicating important information regarding stem cell research and translation
are needed to properly educate the public to enable them to make informed choices,
failing which the public will be infused with false hope based on yet to be proven
scientifi c possibilities.


1.3 Stem Cell Therapy as Biological Medicine

1.3.1 Product Categorization and Registration Requirements

Although it is highly unlikely that all stem cell products will fi t comfortably into a
single category, stem cells, with their very unique qualities and abilities, could qual-
ify as either drugs, biologics, devices, or combination products. It has been argued
that stem cells could in some circumstances qualify as “drugs” in terms of the
Federal Food, Drug, and Cosmetics Act (FD&C Act Sec. 201 2006 ), considering
that stem cells might generate proteins in large quantities such as the protein inter-
feron which was regarded as a drug by the court in the matter of Moore v Regents of
the University of California ( 1990 ), or may be used as a “device” to deliver other
products to the right place in a patient’s body (Munzer 2012 ). In most jurisdictions,
stem cell-based products are categorized as biological products or biologics, which
are subject to regulatory approval and registration before they may be marketed


W.M. Botes et al.
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