Biomedical Engineering Reference
In-Depth Information
treatment of spinal cord injury in patients who had received the injury
7-14 days prior to participation in the trial and who met the necessary
clinical criteria. Pre-clinical studies in mice showed remarkable results,
with significant amounts of spinal cord function restored to injured
mice after treatment.
Geron is a biopharmaceutical company focused on generating
innovative new products that are 'first-in-class' for a variety of
cancers and chronic diseases (
http://www.geron.com
). The company
has been operating since 1992 and is based in Menlo Park, California,
with a subsidiary company, Geron Bio-Med, in Edinburgh, Scotland.
On the 'Product' section of their website they list a number of
different biopharmaceuticals they have in development, with an
accompanying graphic illustrating the phase of development each
one is at, from research through to Phase III clinical development.
There are six different products listed for 'Regenerative Medicine',
including glial cells, cardiomyocytes, islets, chondrocytes, osteoblasts
and hepaptocytes.
Geron's focus on spinal cord research developed out of a
collaboration with the University of California, Irvine (Couzin,
2009). Critics of the trial argue, however, that spinal cord injury is
not the best place to start, claiming that the animal models are
insufficient exemplars of spinal cord injury in humans and that
further large animal studies should be conducted (Couzin, 2009).
Other criticisms include concerns about the risks of teratomas or
cancers and the reliability of the cell differentiation process (Couzin,
2009). Geron report, however, that they have conducted a significant
number of animal studies testing for safety and found no evidence of
teratoma formation or any other contra-indications in rat models,
other than some risk of apparently harmless cysts forming in some
animals in one study (
http://www.geron.com/grnopc1trial/grnopc1-
sec3.html
). It was this study that led to the FDA suspension of the
trial before it was finally allowed to continue (Pollack, 2010).
The product that was being developed in this trial is part of patent
suites owned or licensed by the company (
http://www.geron.com/
grnopc1trial/grnopc1-sec6.html
). Until changing focus in
mid-November, Geron were working on developing an hESC-derived
product that would be commercially produced in its own on-site
