Geron given FDA go-ahead for stem cells trial
By Clive Cookson in London
Published: July 30 2010 19:29 | Last updated: July 30 2010 19:29
The world's first treatment based on human embryonic stem cells is set to begin a clinical trial within the next two months, in patients with acute spinal cord injury.
Geron, a Californian biotech company, announced on Friday that the US Food and Drug Administration would allow the trial to proceed without any further delay. Last year the FDA put Geron's trial "on clinical hold” because of safety concerns raised by one of the animal studies used to support the application. Further testing on rats has addressed those concerns.
The product, known as GRNOPC1, consists of immature nerve cells grown from stem cells that were derived originally from human embryos at a very early stage of development.
The cells will be injected into the damaged spinal cord of accident victims. If the cells behave in people as they have done in animals with spinal injury, they will partially repair the damaged nerves and restore some movement to paralysed patients.
"The neurosurgical community is ready to begin the clinical testing of this new approach to treating devastating spinal cord injury,” said Richard Fessler, professor of neurological surgery at Northwestern University in Chicago. "If found to be safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year.”
Embryonic stem cells can potentially be guided to become almost any human tissue, which gives them great potential in "regenerative medicine”.
But their original creation from human embryos has made them politically and ethically controversial, particularly in the US where the Bush administration severely restricted their creation for research.
Other researchers working on stem cells in universities and industry are keen for Geron's clinical trial to start, because successful results would give a huge boost to the whole field.
William Caldwell, chief executive of Advanced Cell Technology, a Massachusetts stem cell company, said: "We are very excited that Geron was able to overcome the issues raised by the FDA and can now move ahead with clinical trials. The whole industry needs wins.”
ACT has asked the FDA for permission to start treating patients who suffer from Stargardt's macular dystrophy, a form of blindness, with retinal cells derived from human embryonic stem cells.
But the agency has asked the company for further safety data.
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