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U.S. approves first stem cell study for spinal injury

January 26, 2009
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U.S. biotech company, Geron Corporation, Menlo Park, Calif., plans to start this summer the world''s first study of a treatment based on human embryonic stem cells -- a long-awaited project aimed at spinal cord injury. The Associated Press reports that the company gained federal permission this week to inject eight to 10 patients with cells derived from embryonic cells. 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. Whatever its outcome, the study will mark a new chapter in the contentious history of embryonic stem cell research in the United States -- a field where debate spilled out of the laboratory long ago and into national politics. While some overseas doctors claim to use human embryonic stem cells in their clinics, stem cell experts said they knew of no previous human studies that use such cells. 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. The company says the project involves stem cells that were eligible for federal funding under the Bush administration, although no federal money was used to develop the experimental treatment or to pay for the human study. In the Geron study, the injections will be made in the spine at the site of damage. The work will be done in four to seven medical centers around the country. Animal studies suggest that once injected, the cells will mature and repair what is essentially a lack of insulation around damaged nerves, and also pump out substances that nerves need to function and grow. Apart from assessing safety, investigators will hope to see some signs of improvement in the patient. The idea is to provide some level of ability that can be improved by physical therapy. The study will follow each patient for at least a year. Geron Corp. has spent at least $100 million on human embryonic stem cell research. The company is considered the world''s leading embryonic stem cell developer thanks to its claims on several key stem cell technologies. Geron helped finance researchers at the University of Wisconsin who first isolated human embryonic stem cells in 1998. The company has retained exclusive rights on several of those cell types.

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