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"这是一个非常令人兴奋的新闻,但,最重要的是,它证明了对人体无害,而不是带来了 多少益处。" 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. 原始网址: http://www.bbc.co.uk/news/health-11517680 -- 中文: http://0rz.tw/r4JXU 美国医生已开始利用人类胚胎干细胞治疗一名脊髓受伤的病患,使这种富有争议的疗法首 次应用在人类身上。 这名病患8日在亚特兰大的Shepherd脊髓和脑部受伤复健中心,开始接受Geron公司发展出 来的GRNOPC1人类胚胎干细胞治疗。 研究结果发现如在脊髓受伤七天後注射GRNOPC1,能使患者的运动机能大为改善。 GRNOPC1含有寡树突先驱细胞,能够变成会制造髓鞘的寡树突细胞,而神经细胞是靠着包 覆其外层的髓鞘传导讯息。身体一旦因受伤而失去这些细胞,可能陷於瘫痪。如果 GRNOPC1确有效用,先驱细胞将能在脊髓受损部位制造新的寡树突细胞,并可能让身体恢 复运动机能。 参与人体试验的患者必须是在最近两周内受伤,并在受伤之後7天至14天内接受GRNOPC1注 射。 初步临床试验是为了确定这种疗法是否安全,以及人体对GRNOPC1的容忍程度。 Geron公司说,他们1999年开始进行人类胚胎干细胞研究时,许多人都预期细胞疗法还得 再过几十年才能获准进行人体临床试验,可是他们11年後就展开试验,希望促使受损的神 经细胞重新生长,让患者恢复感觉和活动能力。 美国每年约有1万2000人脊髓受伤,大多是因车祸、跌倒、受到枪击或运动事故。 Geron公司去年1月获联邦食品药物管理局批准,对GRNOPC1展开人体实验。大约六周後, 欧巴马总统推翻布希政府颁布的禁令,准许联邦资助人类胚胎干细胞研究。 展开临床试验虽是干细胞治疗的一个重要里程碑,可是这种科技要获准上市还很遥远。 Geron公司打算在美国各地接受八到十名患者进行初期试验。这种研究将持续大约两年, 每个病患接受研究一年。如证明新疗法安全无虞,将展开持续更久的更大规模研究,以检 验其效能。 --



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