Stem cell trial nearly a go?

The first clinical trial treatment based on embryonic stem cells may soon get the go ahead. In May, the Food and Drug Administration linkurl:placed a hold;http://www.the-scientist.com/blog/display/54647/ on a clinical trial application submitted by Geron Corporation, a California-based biotech. The company submitted a 22,500-page Investigational New Drug application to the FDA for an embryonic stem cell-derived compound -- called GRNOPC1 -- to treat spinal cord injury. Geron president and CEO

By | October 17, 2008

The first clinical trial treatment based on embryonic stem cells may soon get the go ahead. In May, the Food and Drug Administration linkurl:placed a hold;http://www.the-scientist.com/blog/display/54647/ on a clinical trial application submitted by Geron Corporation, a California-based biotech. The company submitted a 22,500-page Investigational New Drug application to the FDA for an embryonic stem cell-derived compound -- called GRNOPC1 -- to treat spinal cord injury. Geron president and CEO, Tom Okarma, said at the New York Stem Cell Foundation conference at Rockefeller University on Wednesday (October 15) that the company has had to "educate" the FDA on all the procedures used to grow, quantify, and characterize their stem cell populations. He added that there is no evidence of political pressures behind the hold, and he thinks the FDA did the right thing to hold the trial, in order to get a grasp on the science and ensure safety. But the FDA is nearing the end of its linkurl:review process;http://www.the-scientist.com/blog/display/54544/ and may lift the hold and allow clinical trials to commence within the next three months, Okarma told The Scientist. "We've got our arms wrapped around it," he added. "It's been a long education process."

Popular Now

  1. What Budget Cuts Might Mean for US Science
    News Analysis What Budget Cuts Might Mean for US Science

    A look at the historical effects of downsized research funding suggests that the Trump administration’s proposed budget could hit early-career scientists the hardest.  

  2. UC Berkeley Receives CRISPR Patent in Europe
    Daily News UC Berkeley Receives CRISPR Patent in Europe

    The European Patent Office will grant patent rights over the use of CRISPR in all cell types to a University of California team, contrasting with a recent decision in the U.S.

  3. Opinion: On “The Impact Factor Fallacy”
  4. Unstructured Proteins Help Tardigrades Survive Desiccation
Business Birmingham