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FDA OKs embryonic stem-cell human trial

WASHINGTON, Jan. 23 (UPI) -- The U.S. Food and Drug Administration approved the first-ever human trial of a medical treatment derived from embryonic stem cells.

"This marks the beginning of what is potentially a new chapter in medical therapeutics -- one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells," Thomas Okarma, Geron Corp. president and chief executive officer, said in a release announcing the FDA decision.

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Geron, a California bio-technical company, was approved to begin a study of its stem-cell treatment for spinal cord injuries in up to 10 patients, The Wall Street Journal reported Friday.

"If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year," said Richard Fessler, professor of neurological surgery professor at Northwestern University.

Limits on stem-cell research imposed by the Bush administration have impeded academic and corporate research. President Barack Obama said during the campaign that overturning research limits was a top priority for his administration.

Peter Wilderotter, president and CEO of the Christopher & Dana Reeve Foundation, called the human trial the "dawn of basic research being translated into human clinical trials for people living with spinal cord injury."

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The Christopher and Dana Reeve Foundation, named for the late paralyzed U.S. actor and his wife, is dedicated to curing spinal cord injury by funding research and improving the quality of life for people living with paralysis.

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