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The outgoing Bush Government was a well known opponent of stem cell research, while the incoming Obama Administration was publicly supportive of such research. It therefore came as no surprise last week when the FDA suddenly allowed clearance of the first human clinical trial using embryonic stem cell therapy in patients with acute spinal cord injury.
On Friday, the CEO of Geron Corp, Dr Tom Okarma, was interviewed live on CNBC and had this to say:
instrumental in slowing down the progress in a number of ways. But we
have really no direct evidence that that actually influenced the FDA's
review. So, we really have no view that there was a political overhang
at the FDA."
You can find out more from the company press release and the online recording of the webcast.
Geron's website explains their approach with stem cells quite succinctly:
of cancer and chronic degenerative diseases, including spinal cord
injury, heart failure and diabetes. The company is advancing an
anti-cancer drug and a cancer vaccine that target the enzyme telomerase
through multiple clinical trials. Geron is also the world leader in the
development of human embryonic stem (hESC) cell-based therapeutics. The
company has received FDA clearance to begin the world's first human
clinical trial of a hESC-based therapy: GRNOPC1 for acute spinal cord
The whole stem cell field is based on a entirely different approach from patients popping a pill or being given an injection or infusion of a drug therapeutic. Instead, the restoration of organ function achieved by the injection of healthy,
functional replacement cells manufactured from human embryonic stem
cells. Embryonic stem cells are pluripotent, which means they can turn into any type of cell in the body and can self renew indefinitely in the undifferentiated state due to high levels of telomerase.
So how does the treatment work? In the WSJ Health Blog, they summarised it as thus:
that covers nerve cells and is often severely damaged in spinal cord
injuries. A previous study
found that paralyzed rats who received the treatment within days of
injury generated new myellin (sic) and improved their ability to walk more
than rats treated with a placebo."
It should be noted that the clinical trial is a very early phase I study and there are no guarantees that the concept with translate from animals to humans. In
this trial, researchers will inject a stem cell-based therapy directly
into the spinal cords of patients who have recently suffered severe
Overall, it's an interesting concept and thus we wait with baited breath for a while to see how the results will pan out.