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美政府首次为胚胎干细胞治疗亮绿灯
作者:USMedEdu
发表时间:2010-08-05
更新时间:2010-08-05
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美政府首次为胚胎干细胞治疗亮绿灯

撰文:Andy Coghlan
译者:Docofsoul
《新科学家》2010年8月3日13:12报道

http://www.dxy.cn/bbs/post/view?bid=116&id=17912895


It has taken more than five years of graft, but at long last approval has been given for the first clinical trial using human embryonic stem cells (hESCs). These cells can develop into all tissues of the body.

人类胚胎干细胞(hESCs)移植这事儿整整折腾了5年多,终于如愿以偿,首次获得了临床试验许可。 这种细胞可以生长为身体内所有类型的组织。

Geron Corporation of Menlo Park, California, received the green light from the US Food and Drug Administration this week to use cells derived from hESCs to treat people with acute spinal cord injuries.

本周,位于加州门洛帕克的杰龙公司(Geron Corporation)接到美国食品与药物管理局(FDA)给开的绿灯,恩准用来自hESCs的细胞治疗急性脊髓损伤患者。

Ten people will receive injections into the injury site of hESC-derived oligodendrocyte progenitor cells, which stimulate the growth of new and severed nerves and recoat damaged nerves with myelin. The hope is that the injections will help people recover function lost through injury, as seen in rodent studies in 2005.

10名患者的损伤部位将接受来自hESC的少突细胞祖细胞注射。这些干细胞将刺激新的神经细胞生长、使断裂的神经再生,并且,髓磷脂也将覆盖受损神经。 预期中注射将有助于患者恢复因受伤而丧失的功能,正如2005年的啮齿动物研究业已展示的。

Geron first received permission to proceed in January last year, only for the FDA to withdraw it in August following studies showing that some animals developed benign cysts around the injection sites. Further animal studies led to the FDA's change of heart.

去年一月,杰龙公司先是被允许继续进行研究,可是到八月份风向就变了,FDA撤消了这一许可。因为FDA接到了相关研究报告,显示有一部分动物注射部位周围出现了良性囊肿,而进一步的研究则导致FDA改变心肠而食言自肥。

Chris Mason, a professor of regenerative medicine at University College London, says that the approval is excellent news and "well overdue".

伦敦大学学院再生医学教授Chris Mason评论说,现在FDA同意了,虽然“姗姗来迟”,但的确非常棒。

"We just don't know how hESC therapies will behave in humans unless we actually administer them to patients in the course of a properly conducted clinical trial," says Mason. "When we look back in 25 years, putting the first embryonic stem cells into humans will prove as momentous as man's first step on the moon."

Mason说:“没有经过适当的人类临床试验程序,hESC疗法好不好那是无法知晓的。回顾25年前,当时首次把胚胎干细胞用于治疗人类患者,历史将证明:那是人类在生命的“月球”上迈出的第一步!”

(Docofsoul 译于2010-08-05)

============================================================

美政府首次为胚胎干细胞治疗亮绿灯
撰文:Andy Coghlan
译者:Docofsoul
《新科学家》2010年8月3日13:12报道


人类胚胎干细胞(hESCs)移植这事儿整整折腾了5年多,终于如愿以偿,首次获得了临床试验许可。 这种细胞可以生长为身体内所有类型的组织。

本周,位于加州门洛帕克的杰龙公司(Geron Corporation)接到美国食品与药物管理局(FDA)给开的绿灯,恩准用来自hESCs的细胞治疗急性脊髓损伤患者。

10名患者的损伤部位将接受来自hESC的少突细胞祖细胞注射。这些干细胞将刺激新的神经细胞生长、使断裂的神经再生,并且,髓磷脂也将覆盖受损神经。 预期中注射将有助于患者恢复因受伤而丧失的功能,正如2005年的啮齿动物研究业已展示的。

去年一月,杰龙公司先是被允许继续进行研究,可是到八月份风向就变了,FDA撤消了这一许可。因为FDA接到了相关研究报告,显示有一部分动物注射部位周围出现了良性囊肿,而进一步的研究则导致FDA改变心肠而食言自肥。

伦敦大学学院再生医学教授Chris Mason评论说,现在FDA同意了,虽然“姗姗来迟”,但的确非常棒。

Mason说:“没有经过适当的人类临床试验程序,hESC疗法好不好那是无法知晓的。回顾25年前,当时首次把胚胎干细胞用于治疗人类患者,历史将证明:那是人类在生命的“月球”上迈出的第一步!”

(Docofsoul 译于2010-08-05)



Green light for first embryonic stem cell treatment

13:12 03 August 2010 by Andy Coghlan
For similar stories, visit the Stem Cells Topic Guide


It has taken more than five years of graft, but at long last approval has been given for the first clinical trial using human embryonic stem cells (hESCs). These cells can develop into all tissues of the body.

Geron Corporation of Menlo Park, California, received the green light from the US Food and Drug Administration this week to use cells derived from hESCs to treat people with acute spinal cord injuries.

Ten people will receive injections into the injury site of hESC-derived oligodendrocyte progenitor cells, which stimulate the growth of new and severed nerves and recoat damaged nerves with myelin. The hope is that the injections will help people recover function lost through injury, as seen in rodent studies in 2005.

Geron first received permission to proceed in January last year, only for the FDA to withdraw it in August following studies showing that some animals developed benign cysts around the injection sites. Further animal studies led to the FDA's change of heart.

Chris Mason, a professor of regenerative medicine at University College London, says that the approval is excellent news and "well overdue".

"We just don't know how hESC therapies will behave in humans unless we actually administer them to patients in the course of a properly conducted clinical trial," says Mason. "When we look back in 25 years, putting the first embryonic stem cells into humans will prove as momentous as man's first step on the moon."

http://www.newscientist.com/article/dn19254-green-light-for-first-embryonic-stem-cell-treatment.html

===========================================================




Green light for first embryonic stem cell treatment 

13:12 03 August 2010 by Andy Coghlan
 For similar stories, visit the Stem Cells Topic Guide

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