Biomedical Engineering Reference
In-Depth Information
In the US, cellular products are regulated under the FDA's Good
Tissue Practices Final Rule (Carpenter et al., 2009). This ruling
divides cell products into three separate classes based on the level of
manipulation of the material and the intended use (Carpenter et al.,
2009). For example, autologous uses of minimally manipulated
cellular products, such as one's own knee cartilage, are a Class 1
product at the least restricted end of the scale (Carpenter et al.,
2009). The other end of the scale includes pluripotent stem cells
derived from donor material (Carpenter et al., 2009). iPSCs
generated for autologous uses might be either Class 2 or Class 3
products, depending on the level of manipulation and how
pluripotency was induced. At this stage, there are no iPSC-derived
therapies on the market, but the FDA rules will apply to any new
developments.
In the US, Cellular Dynamics International is already selling
iPSC-based products for use in drug screening, toxicity and other
research (
http://www.cellulardynamics.com
). They currently have
cardiomyocytes for sale, and are in the process of developing
hepatocytes, neurons, endothelial cells and haematopoietic cells.
Research published in July 2011 shows that Cellular Dynamics
International is also working on iPSC-derived retinal cells for
potential use in transplantation into patients (Meyer et al., 2011).
StemGent also sell a number of iPSC lines, in addition to a wide
range of products, reagents, media and transcription factors needed
for research in the stem cell sciences (
http://www.stemgent.com
).
They currently have six mouse iPSC lines available for purchase.
These materials are primarily research materials, so do not need to
adhere to GMP for now. However, the future development of
iPSC-based therapies will need to be GMP compliant.
In the European Union, there are quite specific directives that
govern the use of tissues and cells for clinical use (Hoeyer, 2010).
While currently most iPSCs are used non-clinically, the possibility of
clinical uses is not that far off. There are three main directives that
impact on any tissue-engineered products in the EU: 93/42/EEC on
medical devices, 2001/83/EC on medical products for human use
and 2004/93/EC on tissues and cells (Heinonen et al., 2005).
Directive 2004/23/EC specifically addresses quality and safety in
