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美国各媒体对FDA批准人类干细胞用于临床试验的报道综述 ' a- R4 K) ]9 @; L, i. `. E, Z
First FDA-approved trial using human embryonic stem cells underway.2 i3 }; {+ }# G9 [1 M) O' E$ C+ A% Y# L
The Washington Post (10/12, Stein) reports, "Doctors have injected millions of human embryonic stem cells into a patient partially paralyzed by a spinal cord injury, marking the beginning of the first carefully designed attempt to test the promising but controversial therapy, officials announced Monday." This "patient was treated Friday at the Shepherd Center...in Atlanta that specializes in spinal cord and brain injuries, according to announcement by the hospital and Geron Corp. of Menlo Park, Calif., which is sponsoring the research." While "the cells have been tested in animals, and some clinics around the world claim to offer therapies using human embryonic stem cells, the trial is the first to have been vetted by a government entity and aimed at carefully evaluating the strategy." The FDA approved the trial in July.
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USA Today (10/12, Vergano) reports that "the FDA held up approval of the clinical trial for months, requesting extra animal safety studies and added steps for patient protection, primarily out of fears that the injected cells would grow into tumors or trigger extra pain." The paper says that in spite of "the hopes of medical advocates, research using human embryonic stem cells has been highly controversial."
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The Los Angeles Times (10/12, Khan) reports, "In the animal trials, rats with spinal cord damage that had lost control of their hind limbs regained at least the partial ability to walk and run after treatments with the stem cells." And, "in addition to the Shepherd Center, Northwestern University near Chicago has been announced as a site for this phase of the trial, and up to seven centers ultimately may be involved."1 t, H. D, z; f
1 n! W% \$ U, [3 p: B CThe AP (10/12) says, "While a milestone in the technology, the drug candidate is still a long way from being proven and reaching the market. It still faces many years of testing for effectiveness if all goes well in the early stage study." The Wall Street Journal (10/12, Xu) also covers the story.
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* d2 U' s8 ?/ r8 G& OReference: http://www.uschie.org/web/en/med ... ryonic-fda-approved
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