Stem Cell Scientist Sets Record Straight on Spinal Cord Injury Trials
By Kristen Philipkoski August 08, 2007 | 1:35:19 PMCategories: Stem
Cell Research
There's been lots of confusion and some mischaracterization
when the first embryonic stem cell clinical trial might take place
and what it might treat. Spinal cord injury has been a leading
candidate. Hans Keirstead, a scientist at the University of
California at Irvine has been at the center of the discussions. His
work, which has helped rats with severed spinal cords "walk" again,
is funded by Geron, a biotech company in Northern California. Geron
executives have adjusted their timeline for trials several times,
which is perhaps understandable but has led to some of the confusion.
Keirstead has addressed a spinal cord injury message board to clear
things up. He's got three projects in the works, the first of which
does not use stem cells at all (it's an antibody, thanks Steven!) The
second will use embryonic stem cells to treat acute (i.e. recent)
spinal cord injures. The third and newest effort addresses chronic
spinal cord injuries.
Read Keirsteads full post from CareCure after the jump. Not to get
sappy or anything, but that last paragraph makes me want to, I don't
know, have brunch with him.
In response to a recent news misquote and queries over the last year,
I would like to clarify my views on the timeline to the clinic for
the treatments being developed by my research team.
It would be foolish and misleading to say that one will cure or `fix'
someone with a spinal cord injury in a given period of time. I hope
that through perseverance and a lot of hard work our research
developments will benefit people's lives, but I have no orb with
which to predict the future.
What I do know is this: the treatments that we are developing improve
the outcome of spinal cord injury in rats but do not completely cure
them. We do not know if these approaches will work in humans until we
test them in humans. Importantly, the U.S. Food and Drug
Administration (FDA), informed by clinical trial results, will
ultimately determine if and when a treatment becomes available to the
public.
The first potential treatment that my research team has developed is
an injection-based therapy intended for acute spinal cord injury,
meaning that it would be administered within hours of the injury. The
treatment significantly decreases spinal cord loss when administered
within this narrow time frame. After developing the treatment, our
team and others showed that it improved the outcome of rodent models
of spinal cord injury, multiple sclerosis, rheumatoid arthritis and
ulcerative colitis. In 2006, Medarex Corporation began a clinical
trial evaluation of this approach in patients with ulcerative
colitis. We are overjoyed to see this treatment being tested in
humans, and hope to see the treatment used `off-label' in spinal cord-
injured people should the ulcerative colitis trials prove successful.
The second potential treatment that my research team has developed is
intended for sub-acute spinal cord injury, to be administered within
weeks of the injury. This treatment is a human embryonic stem cell-
based therapy that re-insulates the electrical conduits of the spinal
cord that lost their insulation following injury. Our research team
has shown that this treatment bettered the outcome of rodent models
of spinal cord injury and is safe. Further safety tests are now being
conducted, and Geron Corporation is planning a clinical trial using
this approach in 2008. They deserve our support for their pioneering
and heroic efforts to get the first FDA-approved human embryonic stem
cell-based treatment to the clinic.
The third potential treatment that my research team is developing is
intended for chronic spinal cord injury. Ideally, this therapy could
be administered months, years or decades after an injury, and
understandably is a research direction that has created great
excitement among the spinal cord injury community. However, it is
important for people to understand that we have only just begun this
endeavor. We have not yet even determined whether the tools that we
have developed work in animal models or are safe. The outcome of
these early studies will determine if and when this therapeutic
approach will move forward to further animal testing and, ultimately,
clinical evaluation.
I promise that my research team will push towards the goal of
treating spinal cord injured people with intellectual rigor and
tremendous personal intensity. We understand that our job is to
invent safe and effective treatments that may then be evaluated in
the clinic. I expect that we will fail and succeed along the way, and
thank you in advance for allowing us to do both.
http://blog.
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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