First Embryonic Stem-Cell Trial Gets Approval From the FDA

By RON WINSLOW and ALICIA MUNDY

In a watershed moment for one of the most contentious areas of science
and American politics, the U.S. Food and Drug Administration cleared the
way for the first-ever human trial of a medical treatment derived from
embryonic stem cells.

Geron Corp., a Menlo Park, Calif., biotechnology company, is expected to
announce Friday that it received a green light from the agency to mount
a study of its stem-cell treatment for spinal cord injuries in up to 10
patients. The announcement caps more than a decade of advances in the
company's labs and comes on the cusp of a widely expected shift in U.S.
policy toward support of embryonic stem-cell research after years of
official opposition.

"This is the dawn of a new era in medical therapeutics," said Thomas B.
Okarma, Geron's president and chief executive officer. The hope that
stem-cell therapy will repair and regenerate diseased organs and tissue
"goes beyond what pills and scalpels can ever do."
[stem cells]

Limits on stem-cell research, which prevented federal funding and were
imposed by Congress and former President George W. Bush for ethical and
religious reasons, have had a chilling effect on both academic and
corporate research involving such cells. Proponents of stem-cell
research say restrictions have delayed development of promising new
treatments, while critics contend that harvesting stem cells from
embryos destroys human life.

President Barack Obama said during his campaign that overturning
research limits would be a top priority in his administration.

Both Geron and the FDA said the timing of the decision to approve the
study was coincidental. "The FDA looks to the science on these types of
issues, and we approve [such applications] based on a showing of
safety," said Karen Riley, an FDA spokeswoman. "Political considerations
have no role in this process."

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Thank god almighty, Bush is gone at last, and these research doors will
be wide open.