美国施行全球首例人类胚胎干细胞临床试验

美国杰龙生物医药公司（Geron Corporation）10月11日宣布，佐治亚州亚特兰大“牧者中心”医院已于10月8日利用该公司培植的GRNOPC1人类胚胎干细胞，展开全球首宗人类胚胎干细胞治疗的人体临床试验。

2 c* M6 ]4 s# d" t4 E不过，据报道，亚特兰大这所脊髓和脑损伤康复医院“牧者中心”医院发言人以维护患者隐私为由，并未透露试验细节。杰龙公司在该医院展开临床试验，以评估该公司生产的GRNOPC1人体胚胎干细胞用在治疗脊髓损伤方面的安全性与耐受性。
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- R, X9 X3 v. b这是获得美国政府批准的首个胚胎干细胞人体临床试验。
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外界只知道接受这项实验性治疗是针对脊髓受伤的伤病员。伤者必须在受伤后7到14天内，就接受注射GRNOPC1人类胚胎干细胞。

) q1 l7 l! D% [7 r杰龙公司执行总裁欧卡马说：“展开GRNOPC1临床试验是人体胚胎干细胞疗法的里程碑。”

报道介绍说，干细胞是未经分化的细胞，而人体胚胎干细胞则是取自人类受精卵发育几天后的胚胎，所以能否用人体胚胎干细胞来治疗疾病在道德上一直存有争议。
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First patient treated in Geron stem cell trial（Reuters）

- k5 O( W* X* w2 R; C0 E  V) p(Reuters) - U.S. doctors have begun treating the first patient to receive human embryonic stem cells, but details of the patient enrolled in the landmark clinical trial are being kept confidential, Geron Corp said on Monday.
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& N) W  v6 j/ U5 v+ R# A7 G1 gGeron, whose shares were up 6.4 percent on the Nasdaq late on Monday afternoon, has the first U.S. Food and Drug Administration license to use the controversial cells to treat people, in this case patients with new spinal cord injuries. It is the first publicly known use of human embryonic stem cells in people.

3 b, G" q# e; [4 T1 ~"The patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta, Georgia," Geron said in a statement.

"Shepherd Center is one of seven potential sites in the United States that may enroll patients in the clinical trial."
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Northwestern University in Chicago is also ready to enroll patients.
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6 m0 }3 x2 R5 KGeron's stem cells come from human embryos left over from fertility treatments. They have been manipulated so that they have become precursors to certain types of nerve cells.
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The hope is that they will travel to the site of a recent spinal cord injury and release compounds that will help the damaged nerves in the cord regenerate.

The Phase I trial will not be aiming to cure patients but to establish that the cells are safe to use. Under the guidelines of the trial, the patients must have very recent injuries.

; p, x0 Y5 R, B+ e' FGeron said the Shepherd Center would keep details of the patient confidential.

. k  E  ?8 F3 L* @"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," Geron President and CEO Dr. Thomas Okarma said in a statement.
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* c. L, b- v0 R% Z9 d- C'GREAT NEWS'
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"It's great news -- my hat's off to them for being the first," Dr. Bob Lanza of Massachusetts-based Advanced Cell Technology, which has a human embryonic stem cell trial close to FDA approval, said by email.
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- R& l" d- f; U) R; Z"It ushers in a new era for stem cell therapy. We hope to follow them into the clinic very soon -- knock on wood -- we're hoping to get the green light from the FDA in the coming weeks."
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5 s* M+ m) [$ E% C" r! V5 ~ACT's product is a human embryonic stem cell trained to become a retinal cell. The company has asked the FDA for permission to use it in patients with Stargardt's macular dystrophy, a genetic eye disease that progresses to blindness.

"If it works, there will hopefully be far fewer critics of research on human embryonic stem cells, especially in the USA," said Robin Lovell Badge of the National Institute of Medical Research at Britain's Medical Research Council.
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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
1 S( R4 E! A& T( `First FDA-approved trial using human embryonic stem cells underway.
& L" m& T+ B( A" N  c  xThe 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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3 S+ i: C3 d8 h4 m/ I+ L8 kUSA 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."
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The 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.

. \& J; P% ]' C! eReference: http://www.uschie.org/web/en/med ... ryonic-fda-approved
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华盛顿邮报十月十二日报道：“医生已经注射了数百万人类干细胞进入一名脊柱受损的病人，这标志着第一例精心准备但存在争议的疗法已经开始实施。”据资助本 次研究的医院和Geron公司的介绍，这名病人是于周五在亚特兰大Shepherd中心接受的该治疗，该中心以治疗脊柱和脑部受损见长。之前，该研究实际 上已经在动物身上做过实验，全球很多医院也宣称可以使用人类干细胞进行多种治疗。FDA则于今年7月批准了该临床试验。
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& O4 ^/ F( z$ J% Z/ t& W今日美国10月12日报道：FDA曾让该临床试验延迟几个月（开始），并要求提供动物安全研究（报告/数据）和增加（临床试验中的）病人保护环节以打消 “注射干细胞可能导致肿瘤生长或导致其他疼痛的顾虑”。文章说到，不论支持者的如何看好前景，研究使用人类干细胞一直存在很大的争议。
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) k% V7 O& [; X) g洛杉矶时报2010年10月12日报道：在动物临床试验中，脊柱受损导致后肢瘫痪的大鼠在接受了干细胞治疗后至少恢复了一部分走动和跑动的能力。除了亚特兰大Shepherd中心外，美国西北大学也将被作为该临床试验的一个地点，可能会有七家医疗机构会涉及整个临床试验。

# e" o; D! u. G) T7 ^据美联社10月12日报道：作为技术上的里程碑，该技术在被证明（有效）以及投放市场之前还有很长的路要走。即使早期研究一切顺利，该技术仍需要进行很多年的测试。华盛顿邮报10月12日的报道中也有同样的内容。
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（译者：Med Qiao Group LLC 陈庆；校对：美中医疗信息交流 编辑部）
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3 l6 T$ Q5 k3 a% O" W9 Q3 a. S引用：http://www.uschie.org/web/zh/med ... ryonic-fda-approved

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