Biomedical Engineering Reference
In-Depth Information
The Geron trial faced significant regulatory hurdles in getting
FDA approval. One reason for this is that as the 'first-in-class' test
protocol, there are no established standards for the regulatory
agency to evaluate Geron's documentation against (Strauss, 2010).
At least part of the lack of standardization is argued to be attributable
to the nature of the field in that each cell does something very
specific, so defining a general standard for all cells is challenging
(Strauss, 2010). Other concerns around standardization include the
way that cells are cultured in the laboratory, how patent claims
might be evaluated, adequate tests of efficacy in comparison to
existing treatments and follow-up treatment given that stem cells are
permanently injected into a body (Strauss, 2010).
A press release on the Geron website states that as of October
2011, four patients had been treated in the trial, with no adverse
reactions occurring so far, although one patient experienced minor
side effects associated with the immune suppression drugs taken for
the first 30 days after treatment. The criteria for participation in the
trial was quite strict, limited to patients between 18 and 65 with very
specific types of injuries to one area of the spine only, resulting in
paraplegia (
http://www.clincaltrials.gov
). Until the trial was closed
in late 2011, Geron were ready to open up further sites around the
US to patient enrolment. They had also obtained approval to expand
the recruitment criteria to patients with slightly different injuries and
approval for a reduction in the time between each patient treatment
from 30 days to ten.
Until it was closed to further recruitment, the trial appeared to be
going well. Geron states that the patients who were enrolled in the
trial will continue to participate in the trial, though the data is too
immature at this stage to be an accurate indicator of what the future
might hold. The nature of the recruitment protocol meant that not
all patients who fit the criteria would necessarily have been able to
gain entrance to the trial, although the reduction in time periods
between patients would have facilitated greater access to the study.
Also, the short time span between sustaining an injury and obtaining
treatment under the trial protocol was another issue that could have
potentially limited the numbers of prospective participants. For a
'first-in-class' experiment in clinical treatments involving human
