Geron's treatment for spinal injury GRNOPC1 is based on embryonic stem cells and is stalled in its clinical trials.
As if waiting for eight years wasn’t bad enough, we could see another few months pass before the first clinical trials for embryonic stem cells get underway. Geron (Nasdaq: GERN) won FDA approval for these trials back in January. Mid-August saw announced delays, and Geron finally revealed why on August 27th: cysts. As we mentioned before, Geron is looking to create a therapy for spinal cord injuries, and their latest round of animal tests revealed a larger than expected occurrence of small cysts. The official press release points out that these cysts are microscopic, not spreading, and actually fairly common with spinal injuries. Geron is dedicated to working with the FDA to get the trials back on track as soon as possible.
Being the first embryonic stem cell research to get FDA approval for clinical trials means that all eyes are on Geron. This is what people have been dreading/hoping for: that humans will finally see the benefits of the much debated use of stem cells from frozen embryos. It’s the sort of work that Christopher Reeves advertised for and that many pressured George W. Bush to prevent.
Successful or stalling, Geron’s research has large implications for the rest of the stem cell community. If they find a successful spinal cord therapy, thousands of patients in the US and abroad may finally find a way to reverse devastating injuries. Just as importantly, however, if Geron fails before they have a chance to start, or has its FDA approval permanently placed on hold, it may discourage investors looking to fund companies utilizing stem cell therapies. Both Geron and the FDA know that, and this hold may be an overly cautious delay to make sure that no larger problems arise later in the clinical trial.
How serious is the cyst problem? Geron uses human embryonic stem cells to generate progenitor cells that regulate spinal cord nerve coverings. A cocktail of these cells, called GRNOPC1 is injected into mice that have been given a spinal lesion. As Geron point out, injuries to the spine such as this one cause much larger cysts in 50% of test subjects anyway. Furthermore, the cysts failed to develop into teratomas, alleviating concerns of uncontrolled cell growth and a repeat of that horrible scene from Total Recall.
While the FDA declines to comment on ongoing holds on clinical trials, Geron’s press release would have you believe they are about to restart at anytime. Even if Geron is permanently stalled, though there’s no reason to think that they would be, embryonic stem cell research will continue. Investor fear may slow things down, but the technology holds such amazing promise that it can’t be contained. Even adult stem cells have been shown to have great success with diabetes, corneal blindness and other diseases. Stem cell research in China is proceeding rapidly, and animal therapies in the US are becoming common. Any way you look at it, the tide of stem cells is too powerful to be stopped by microscopic cysts.
Tags: clinical trials, cysts, embryonic, FDA, GERN, geron, stem cells
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AS a T9 SCI paraplegic I pray for this research to go back on the fast track NOW. I am willing to be a human guinea pig and look forward to one day hopefully soon I can once again walk and dance and with my beautiful wife. Thank you a big Mahalo to President Obama for having made this possible by signing the executive order to allow progress instead of hypocritical religious dogma to prevail.
Nice to see an update on this, even though it has been stalled for the moment.
I also hope that this trial goes forward in the near future. The SCI community is frustrated by the delays. We understand the caution and the implications.
The cysts occurred as Geron conducting increased dosage studies following the original approval. In a way, this delay could ultimately speed up the later phases of dosage and efficacy testing with the product on human subjects. Let’s hope…
With China advancing so far ahead of us with respect to applied stem cell use, it would be good for American competitiveness in this field if these trials meet the the criteria to move ahead. We don’t want the trials proceeding if they are unsafe, but if they pass safety checks, this stands to offer considerable credibility to American solutions.
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