There’s been lots of confusion and some mischaracterizations about 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.
By Kristen Philipkoski