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Embryonic stem cells approved for humans

AN AMERICAN biotech company says it plans to start the world's first study based on human embryonic stem cells - as a treatment for spinal chord injury.

The company gained US Government permission this week to inject 8 to 10 patients with cells derived from embryonic cells, said Dr. Thomas Okarma, President and Chief Executive of Californian firm Geron Co.

The patients will be paraplegics, who can use their arms but can't walk. They will receive a single injection within two weeks of their injury.

The study is aimed at testing the safety of the procedure, but doctors will also look for signs of improvement like return of sensation or movement in the legs, Okarma said.

Whatever its outcome, the study will mark a new chapter in the contentious history of embryonic stem cell research in the US - a field where debate long ago spilled out of the lab and into politics.

While some overseas doctors claim to use human embryonic stem cells in their clinics, stem cell experts said they knew of no past human studies that use such cells.

Ed Baetge, chief scientific officer of Novocell Inc, said "it's a milestone" because Geron passed the safety hurdles for getting federal clearance to launch the study. His company hopes to begin a similar study for treating diabetes in a few years.

Embryonic stem cells can develop into any cell of the body, and scientists have long hoped to harness them for creating replacement tissues to treat a variety of diseases. But research has been controversial because embryos must be destroyed to obtain them.

President Barack Obama has promised to relax the Bush administration's restrictions on federal financing for such research. But Obama's ascent to the White House had nothing to do with the US Food and Drug Administration's granting permission for the new study, Okarma said.

In fact, the company says, the project involves stem cells that were eligible for federal funding under Bush, although no federal money was used.

Other human cells, called adult stem cells, have been tested before in people to treat heart problems.


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