US FDA allows first test of human stem cell therapy
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US Food and Drug Administration (FDA) has cleared the way for the world's first study of human embryonic stem cell therapy.
The move came three days after the inauguration of President Barack Obama, a Democrat who had been expected to rescind some of the federal funding restrictions placed on such research.
The California biotechnology company, Geron, plans to initiate a clinical trial 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 B Okarma said in a statement.
The FDA rejected his company's first request, in March, to conduct the trial.
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 via executive order.
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.
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," Richard Fessler, professor of neurological surgery at the Feinberg School of Medicine at Northwestern University, said.
"If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."
- Reuters
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