Tags: FDA | stem | cell | therapy

FDA Allows First Test of Human Stem Cell Therapy

Friday, 23 Jan 2009 08:35 AM

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WASHINGTON -- The U.S. Food and Drug Administration has cleared the way for the world's first study of human embryonic stem cell therapy, Geron Corp said on Friday.

The California biotechnology company plans to start a clinical trial to try to use the stem cells to regrow nerve tissue in patients with acute spinal cord injury.

"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," Geron Chief Executive Thomas Okarma said in a statement.

Shares of Geron rose nearly 30 percent to $6.75 in premarket electronic trading on Nasdaq.

The FDA rejected his company's first request to conduct the trial of GRNOPC1, Oligodendroglial Progenitor Cells. It put the trial on hold in May.

Former President George W. Bush had been at odds with Congress, researchers and advocates for years over the issue and restricted federal funding of work involving human embryonic stem cells by an executive order.

President Barack Obama, who succeeded Bush on Tuesday, had been widely expected to rescind that directive.

Stem cells are the body's master cells, giving rise to all the tissues, organs and blood. Embryonic stem cells are considered the most powerful kinds of stem cells, as they have the potential to give rise to any type of tissue.

But they are difficult to make, requiring the use of an embryo or cloning technology. Geron and some other companies have been pursuing the goal without the use of federal funds.

Advocates say stem cell-related research could lead to a whole new field of regenerative medicine, in which patients could get transplants and treatments for Parkinson's, juvenile diabetes, cancer, injuries and a range of other ills.

"The neurosurgical community is very excited by this new approach to treating devastating spinal cord injury," said Richard Fessler, professor of neurological surgery at the Feinberg School of Medicine at Northwestern University.

"If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year," he said in a statement.

© Thomson Reuters 2009 All rights reserved

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