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- 2017-05-30 发布于河南
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语言与科技英语第五单元
it was a triumph of science, not politics. Yet the approval for the worlds first clinical trial of a therapy generated by human embryonic stem cells, announced on 23 January, certainly seemed to be deeply political.
It was just three days into US President Barack Obamas term of office when Geron, based in Menlo Park, California, told the world that the US Food and Drug Administration (FDA) had agreed to its phase I safety study of a stem-cell-derived therapy for spinal-cord injury.
But supporters say that the significance of the approval lies not in the ideology of the new administration, but in the considerable scientific hurdles that were overcome in reaching this milestone.
There was a lot of scepticism as to whether we could reliably reproduce these manufactured products at levels of purity and identity sufficient to even allow the FDA to allow a phase I clinical trial, says Michael West, who founded Geron in 1990 and is now chief executive of BioTime in Alameda, California.
Geron, he says, has convinced the FDA that those cells could be manufactured reliably enough for at least the first clinical trials. That is a milestone. A lot of the critics said it would be 30–50 years before we got there.
Financial benefit
The announcement boosted the price of shares in the company, which has an extensive patent portfolio relating to embryonic stem-cell research. As of 26 January, they were trading at US$8.15 a share — up 56% from the day before the announcement.
In the trial, up to ten individuals who have been left paralysed after spinal-cord injury will be injected at the point of injury with stem-cell-derived precursors of oligodendrocytes, which are key supportive cells in the central nervous system. The treatments will start within 7–14 days of their injury. The company hopes that the cells will lay down sheaths of myelin — an insulator essential for conducting nerve impulses — around injured neurons, as well as stimulating nerve cells to regenerate. The cells have
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