Embryonic stem cell trial back on

Nearly a year after the US Food and Drug Administration placed a hold on the first clinical trial of human embryonic stem cells, the company linkurl:Geron;https://www.geron.com/ has been cleared to continue its study of spinal cord injury, linkurl:it announced today;https://www.geron.com/media/pressview.aspx?id=1229 (July 30). Human embryonic stem cellsImage: Wikimedia commons, Nissim Benvenisty"We are pleased with the FDA's decision to allow our planned clinical trial of GRNOPC1 in spinal cord

Written byJef Akst

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Human embryonic stem cells
Image: Wikimedia commons,
Nissim Benvenisty

"We are pleased with the FDA's decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed," Geron's president and CEO Thomas Okarma said in a statement. The Phase I trial, which aims to use human ESC-derived progenitors of neural support tissue to treat patients with severe spinal cord injury, was to be the first-ever clinical trial of a hESC-based therapy when it was cleared by the FDA in January 2009. That August, however, before any patients had received treatment, the FDA linkurl:placed a hold;https://www.the-scientist.com/blog/display/55898/ on the trial after linkurl:cysts appeared;https://www.the-scientist.com/blog/display/55950/ in some of the animals given the treatment in a preclinical study. Since then, Geron completed an additional preclinical animal study to test new markers and assays, according to today's announcement. After submitting these results to the FDA, the hold was lifted, and the company has been cleared to begin administering the treatment to human patients. "Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged," Okarma said -- "to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord."
**__Related stories:__***linkurl:Geron trial may resume next year;https://www.the-scientist.com/blog/display/56126/
[30th October 2009]*linkurl:Cysts stall stem cell trial?;https://www.the-scientist.com/blog/display/55950/
[27th August 2009]*linkurl:Human stem cell trial on hold;https://www.the-scientist.com/blog/display/55898/
[20th August 2009]*linkurl:FDA OKs stem cell trial;https://www.the-scientist.com/blog/display/55353/
[23rd January 2009]

Meet the Author

Jef Akst

Jef (an unusual nickname for Jennifer) got her master’s degree from Indiana University in April 2009 studying the mating behavior of seahorses. After four years of diving off the Gulf Coast of Tampa and performing behavioral experiments at the Tennessee Aquarium in Chattanooga, she left research to pursue a career in science writing. As The Scientist's managing editor, Jef edited features and oversaw the production of the TS Digest and quarterly print magazine. In 2022, her feature on uterus transplantation earned first place in the trade category of the Awards for Excellence in Health Care Journalism. She is a member of the National Association of Science Writers.

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