Biomedical Engineering Reference
In-Depth Information
clean rooms under good manufacturing practices. The hESC line that
they were using is part of the original cell line derived by WARF in
1998, and as the research was originally funded by Geron, they claim
to have an exclusive licence to use it. The actual product administered
to patients was the result of a collaboration between the University
of California, Irvine, and the company, so is also under exclusive
licence to Geron. A search of the USPTO database shows that Geron
have filed a number of patent applications for their range of products
which would give them substantial opportunities to recoup the costs
incurred in research and development.
None of the other treatment modalities in regenerative medicine
being developed by Geron and their collaborators are close to human
clinical trials yet. hESC-derived cardiomyocytes have been undergoing
pre-clinical testing in mice and guinea pigs, with pig trials in
development at the time of writing (
http://www.geron.com
). Geron
are working on improving the yield and growth of hESC-derived islet
cells, with some
in vivo
studies underway (
http://www.geron.com
).
The injection of chrondocytes into rats has shown improved joint
function, with larger animal model studies in development (
http://
www.geron.com
). Improvements in osteoblast production and
in
vivo
application are also being investigated by Geron and collaborators
(
http://www.geron.com
). Hepatocytes and cardiomyocytes have
also been developed in collaboration with GE Healthcare for
disease-in-a-dish drug assays (
http://www.geron.com
).
The original rat studies (Keirstead et al., 2005) demonstrated
improved motor function in injured animals when hESC-derived
'oligodendrocyte progenitor cells' were injected at the site of injury
a week later. By contrast, animals that were treated ten months after
injury showed no improvement. The product enables damaged cells
to repair the protective coatings of myelin that enable them to
function effectively (Keirstead et al., 2005). The stem cell treatment
therefore does not regrow nerve cells as such, but it does allow
enhanced healing capacity that can aid in the retention of sensory
and motor function when used fairly soon after injury. It is thought
that the lack of efficacy in the rats treated at ten months after injury
was due to the build up of scar tissue at the sight of injury (Keirstead
et al., 2005).
