Geron trial may resume next year

The Geron Corporation could be cleared to resume its stalled human embryonic stem cell (hESC)-trial for spinal cord injury in the third quarter of next year, linkurl:the company announced today;http://www.geron.com/media/pressview.aspx?id=1195 (October 30). Human embryonic stem cellsImage: Wikimedia commons, Nissim BenvenistyThe Phase I trial, which received clearance from the US Food and Drug Administration (FDA) in January to administer hESC-derived progenitors of neural support tissue into

Written byJef Akst

| 1 min read

Listen with Speechify

0:00

1:00

Human embryonic stem cells
Image: Wikimedia commons,
Nissim Benvenisty

The Phase I trial, which received clearance from the US Food and Drug Administration (FDA) in January to administer hESC-derived progenitors of neural support tissue into the spinal cords of patients with severe spinal cord injury, is the first-ever clinical trial of a hESC-based therapy. In August, however, before any patients could receive treatment, the FDA put the trial linkurl:on hold after cysts appeared;http://www.the-scientist.com/blog/display/55950/ in some of the animals that had been given the treatment as part of a preclinical study. Since then, Geron has continued its preclinical study of the treatment, using new markers and assays agreed upon with the FDA, according to their press release. If the study continues to show positive results, the FDA has agreed that the trial could restart in the third quarter of next year. Still, "a great amount of work still needs to be done before any patient is ultimately enrolled into the study," Merriman Curhan Ford analyst Joe Pantginis linkurl:told Reuters.;http://www.reuters.com/article/companyNews/idUSBNG38436220091030
**__Related stories:__***linkurl: Cysts stall stem cell trial?;http://www.the-scientist.com/blog/display/55950/
[27th August 2009]*linkurl:Human stem cell trial on hold;http://www.the-scientist.com/blog/display/55898/
[20th August 2009]*linkurl:FDA OKs stem cell trial;http://www.the-scientist.com/blog/display/55353/
[23rd January 2009]

Interested in reading more?

The Scientist ARCHIVES

Become a Member of

Receive full access to more than 35 years of archives, as well as TS Digest, digital editions of The Scientist, feature stories, and much more!

Join for free today

Already a member? Login Here

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.
View Full Profile