"這是一個非常令人興奮的新聞，但，最重要的是，它證明了對人體無害，而不是帶來了 多少益處。" Professor Sir Ian Wilmut -- US doctors have begun the first official trial of using human embryonic stem cells in patients after getting the green light from regulators. The Food and Drug Administration has given a license to Geron to use the controversial cells to treat people with spinal injuries. The cells have the potential to become many of the different cell types found in the body, including nerve cells. The trials at a hospital in Atlanta will check if the treatment is safe. Pivotal research Geron, a biotech company based in "silicon valley" south of San Francisco, has spent $170m on developing a stem cell treatment for spinal cord injury. The research will use cells coaxed to become nerve cells which are injected into the spinal cord. In animal trials of the treatment, paralysed rats regained some movement. But it is not yet known if it will offer any benefit to people with spinal cord injuries. Every year around 12,000 people in the US sustain spinal cord injuries. The most common causes are automobile accidents, falls, gunshot wounds and sports injuries. In the trial, patients who have sustained such an injury within the last 14 days will be given the experimental stem cell treatment. Geron president Dr Thomas Okarma said: "When we started working with human embryonic stem cells in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials. "This accomplishment results from extensive research and development and a succession of inventive steps." But it will take some time to get the results. And there are many years of rigorous testing ahead before it can be known if the therapy is safe and effective. Professor Sir Ian Wilmut, director of the Medical Research Council Centre for Regenerative Medicine at the University of Edinburgh, said: "This is very exciting news, however, it is very important to appreciate that the objective of trials at this stage is to confirm first of all that no harm is done to patients, rather than to look for benefits. "Once that has been confirmed then the focus moves on to development and assessment of the new treatment." Ben Sykes, executive director of the UK National Stem Cell Network, said: "This is indeed a significant milestone in our journey towards the promise of stem cell-based medicines. "The global stem cell and regenerative medicine community will be awaiting the results of this safety trial with much anticipation." Professor Chris Mason, an expert in regenerative medicine at University College London, said UK researchers hope to follow suit and begin trials next year with a stem cell treatment for age-related macular degeneration - a leading cause of blindness. 原始網址： http://www.bbc.co.uk/news/health-11517680 -- 中文： http://0rz.tw/r4JXU 美國醫生已開始利用人類胚胎幹細胞治療一名脊髓受傷的病患，使這種富有爭議的療法首 次應用在人類身上。 這名病患8日在亞特蘭大的Shepherd脊髓和腦部受傷復健中心，開始接受Geron公司發展出 來的GRNOPC1人類胚胎幹細胞治療。 研究結果發現如在脊髓受傷七天後注射GRNOPC1，能使患者的運動機能大為改善。 GRNOPC1含有寡樹突先驅細胞，能夠變成會製造髓鞘的寡樹突細胞，而神經細胞是靠著包 覆其外層的髓鞘傳導訊息。身體一旦因受傷而失去這些細胞，可能陷於癱瘓。如果 GRNOPC1確有效用，先驅細胞將能在脊髓受損部位製造新的寡樹突細胞，並可能讓身體恢 復運動機能。 參與人體試驗的患者必須是在最近兩周內受傷，並在受傷之後7天至14天內接受GRNOPC1注 射。 初步臨床試驗是為了確定這種療法是否安全，以及人體對GRNOPC1的容忍程度。 Geron公司說，他們1999年開始進行人類胚胎幹細胞研究時，許多人都預期細胞療法還得 再過幾十年才能獲准進行人體臨床試驗，可是他們11年後就展開試驗，希望促使受損的神 經細胞重新生長，讓患者恢復感覺和活動能力。 美國每年約有1萬2000人脊髓受傷，大多是因車禍、跌倒、受到槍擊或運動事故。 Geron公司去年1月獲聯邦食品藥物管理局批准，對GRNOPC1展開人體實驗。大約六周後， 歐巴馬總統推翻布希政府頒布的禁令，准許聯邦資助人類胚胎幹細胞研究。 展開臨床試驗雖是幹細胞治療的一個重要里程碑，可是這種科技要獲准上市還很遙遠。 Geron公司打算在美國各地接受八到十名患者進行初期試驗。這種研究將持續大約兩年， 每個病患接受研究一年。如證明新療法安全無虞，將展開持續更久的更大規模研究，以檢 驗其效能。 --

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