北京军区总医院的自体干细胞移植做广告，可恨的骗子。

云帆风影

His father, Hong Gensho, travelled to Shanghai to seek an explanation. But hospital administrators told him his son didn't die in their hospital, paid him 80,000 yuan and told him not to pursue the matter.

"I am miserable, it's like my son was worth only 80,000 yuan. It's not about money. Our human rights, our place in this society, are not respected. I am devastated. If he hadn't sought treatment, he would not have died," said the elder Hong, 61.

"I can't get my son back, but people must know about these stem cell therapies and no one must be deceived."

LACK OF SCIENTIFIC EVIDENCE

Experts have raised the alarm on patients turning up at clinics and hospitals in China, Mexico, India, Turkey, Russia and elsewhere for stem cell therapies that have not undergone clinical trials and which are not recognized as standard treatment.

Patients often pay fees of $20,000 and more for such therapies after exhausting conventional treatments.

"Stem cell tourism is regarded as ethically problematic because patients receive unproven therapies from untrustworthy sources," Dr David Resnik at the U.S. National Institute of
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Ampoules containing a medium for stem cell storage are seen in a file photo.
Credit: Reuters/Peter Macdiarmid
By Tan Ee Lyn

HONG KONG | Wed Sep 21, 2011 9:35am EDT

HONG KONG (Reuters) - Chinese hotel manager Hong Chun had trouble using chopsticks after a minor stroke and sought treatment at a large Shanghai hospital where doctors injected what they said were donor stem cells into his spinal cord and buttocks, according to his father and cousin.

Leaving hospital the next day, Hong, 27, fell so ill he had to be taken off the train and rushed to another hospital. But doctors were unable to save him and he was declared brain dead before dying a month later.

Desperate for help, patients with incurable diseases are admitting themselves into hospitals in China for "stem cell therapies" but experts say such treatments are backed by little or no scientific evidence and are at best experimental.

Some of these cases involve large general hospitals where patients pay thousands, even tens of thousands, of dollars for treatments that are advertised online. Patients have come away with little or no improvement and a number have died, according to patients, doctors and relatives of patients who spoke to Reuters.

Hong paid 30,000 yuan ($4,800) to the Chinese army's 455 PLA Hospital in Shanghai for the treatment last year, according to hospital receipts seen by Reuters.

His father, Hong Gensho, travelled to Shanghai to seek an explanation. But hospital administrators told him his son didn't die in their hospital, paid him 80,000 yuan and told him not to pursue the matter.

"I am miserable, it's like my son was worth only 80,000 yuan. It's not about money. Our human rights, our place in this society, are not respected. I am devastated. If he hadn't sought treatment, he would not have died," said the elder Hong, 61.

"I can't get my son back, but people must know about these stem cell therapies and no one must be deceived."

LACK OF SCIENTIFIC EVIDENCE

Experts have raised the alarm on patients turning up at clinics and hospitals in China, Mexico, India, Turkey, Russia and elsewhere for stem cell therapies that have not undergone clinical trials and which are not recognized as standard treatment.

Patients often pay fees of $20,000 and more for such therapies after exhausting conventional treatments.

"Stem cell tourism is regarded as ethically problematic because patients receive unproven therapies from untrustworthy sources," Dr David Resnik at the U.S. National Institute of Environmental Health Sciences and Zubin Master at the University of Alberta in Canada wrote in a paper published in the journal European Molecular Biology Organization.

Echoing the same concerns, Dr George Daley at the Harvard Stem Cell Institute and Harvard Medical School said he was swamped by enquiries from patients asking about therapies in China and Brazil for diseases from Alzheimer's to spinal cord injuries.

"What I'm talking about are the less legitimate treatments that have not even undergone clinical trials but are directly marketed therapies... We really have no idea how to use stem cells for these treatments," Daley told Reuters.

When contacted by Reuters, a director at the PLA 455 Hospital, who declined to be identified, said: "There are always good and bad outcomes. No therapy can guarantee success to everyone... Besides, you don't have a better alternative.

"As for patients dying, all deaths must be investigated. What caused the death? If our treatment caused the death, the patient (relatives) can seek redress. If it is a death caused by old age and sickness, then there is nothing I can say."

China's Ministry of Health did not respond to questions from Reuters on stem cell therapies being offered in the country.

VICTIMS ARE THOSE FACING DEATH

云帆风影

Suffering from late-stage liver cirrhosis caused by a lifelong hepatitis B virus infection, Fan Hongkun was led to believe her body would spontaneously grow a healthy liver once stem cells were transplanted.

"We saw the therapy advertised online and talked to the doctor over the phone. He said stem cells were like seeds, after being planted on a liver, they grow, divide and spread and finally form a healthy liver," said Fan's son, Zhou Junjie.

Fan, 63, was so convinced, she admitted herself into Beijing Military General Hospital, whose website still carries information on the stem cell therapies it offers.

"My mother said the PLA (Chinese army) doesn't lie. That's why she trusted them," said Zhou.

Doctors there took her off the drug lamivudine for four weeks to "prepare her for the stem cell therapy". But she fell into a coma before doctors could treat her.

Sold under the brand Epivir by GlaxoSmithKline Plc, lamivudine minimizes liver damage by blocking the hepatitis B virus from replicating. Fan's family learnt later from other doctors that she suffered a sudden surge of the virus after she stopped her medication, which pushed her into a coma and killed her.

According to documents seen by Reuters, her family sued the hospital, but the case was dismissed by a Chinese court.

When contacted, a doctor at the hospital, who declined to be identified, said the entire procedure to transplant stem cells into a patient's liver takes only a day.

"We extract the patient's bone marrow cells and isolate the stem cells, which are then inserted into the liver," said the doctor. "...We extract bone marrow cells in the morning and in the afternoon we inject them (stem cells) into the liver. Yes, all it takes is a day. Very fast."

Advertisements for these treatments remain on the hospital's website.

In Ireland, many patients have returned from treatments abroad with no improvement, but they are less willing to talk.

"Virtually none will go on record to state they have been conned. This is mainly because many patients have serious immediate health concerns and they need to focus on that," Stephen Sullivan, chief scientific officer of the Irish Stem Cell Foundation, told Reuters.

"Patients are also reluctant to come forward as they are embarrassed at spending lots of money against professional medical advice. Some patients will even claim improvement when there is no measurable improvement."

云帆风影

POTENTIALLY POWERFUL

Researchers believe regenerative medicine will be a powerful form of therapy in the future. Stem cells are immature, master cells in the body that can grow into any kind of human cell or tissue. Scientists are exploring how to use them to treat a variety of diseases and disorders, including cancer, diabetes and injuries.

But for now, they stress that only one type of stem cell therapy has been proven to work.

"Only bone marrow transplants for diseases such as leukemia, lymphoma are backed by solid evidence and are well-established clinical procedures. The others are not up to that level," said David Siu, clinical associate professor at the cardiology division of Hong Kong's Queen Mary Hospital.

"There is evidence that certain stem cells can grow into new tissue but do they provide a therapeutic effect? We don't have the evidence yet. Some are in clinical research."

For the conditions highlighted in this article - disability from strokes and liver cirrhosis - experts say there are no proven stem cell treatments.

In their paper, Resnik and Master said while most countries had rules governing research on people and medical malpractice, they did not apply directly to stem cell therapy. When doctors encounter strict regimes, they can simply move to other countries with more permissive legal environments.

Experimental stem cell therapies, however, may be legitimately offered to patients, but these must be carried out within the framework of clinical trials that are approved by regulatory boards that ensure ethical standards are met.

"When experimental stem cell therapy is used on patients, it is not performed on an ad-hoc basis but within the framework of a proper clinical trial prepared beforehand," Siu said. "It has to follow a rigorous methodology: what are the risks, what can and cannot be done? If the results are negative, what are the rescue and safety measures?"

Sullivan urged patients to be on the lookout for scams. Suspicious signs include being asked for large sums of money up front, being told there are no risks, and being offered no post-therapy care.

Patients should be told how they will be treated, what stem cells are used and where they come from. They should not accept any therapy based on hearsay, or without the treatment being validated at least in part by peer review, he said.

Resnik and Master urged stem cell scientists, who have control over stem cell lines, to help stop these scams by not releasing such materials to doctors or clinics if they cannot produce proof of conducting a genuine clinical trial.

云帆风影

"This would ensure that the stem cells and other materials are going to be used in the course of responsible biomedical research, a legally sanctioned clinical trial or in responsible medical innovation," they said.

(Additional reporting by Julie Steenhuysen in Chicago, Zoey Zhang and Viola Ho in Hong Kong and Li Hui; Editing by Nick Macfie)

云帆风影

日志原文：http://blog.sohu.com/people/!c2h ... Q==/129743711.html.

[转帖] 卫生部不准干细胞移植用于临床。干细胞真相调查：病床上的“赌博”
本帖最后由 op 于 2009-5-17 05:46 编辑

如果有人说，他今天就能让物理学家霍金站起来，人们多半会报以怀疑；霍金本人或许也会摇头：这不可能。

　　尽管“霍金们”都对医院和医生寄予厚望，但可惜，医学技术还没有我们期待的那样“神奇”，对于这一类疾病，医学上目前还没有快捷有效的治疗方法。

　　很多神经系统的疾病就是这样。肌萎缩性侧索硬化症把霍金的身躯限制在一台智能轮椅上，拳王阿里因帕金森综合征而雄风不再，中国的桑兰也在严重的脊柱伤残后，丧失了下半身的活动能力，还有更多的人，一出生就因脑瘫、癫痫、脑叶萎缩而无法自如地生活。

　　目前解决这些“世界难题”的方法，通常是传统的康复训练和治疗。

　　神经干细胞的发现，给解答“世界难题”带来了新的希望，它的诱人之处是，神经干细胞有潜能修复受伤的神经细胞，这是治疗神经系统疾病釜底抽薪的办法。只不过对于应用神经干细胞安全治疗疾病的方法，科学家们的探索还在路上，病人们只能耐心等待。

　　病笃乱投医，如果能够得到哪怕还在实验中的治疗，许多的病人也是趋之若鹜，问题是，“神经干细胞移植”这个未来的技术，我们可以提前享有吗？目前的临床治疗是否符合“规范”？其中有无见利忘义的浮躁和盲目？(黄 祺)

　　病床上的“赌博”

　　“神经干细胞移植”究竟是一个什么样的治疗，自己的不幸是“神经干细胞”无法治疗的10%，还是“神经干细胞移植”根本就是临床“实验”？

　　撰稿／黄 祺(记者)

　　“神奇”治疗

　　小董很想扭头看看神奇的“神经干细胞”到底长啥样，他想知道，花1万多元，往身体里注射的究竟是什么东西，护士并没有让他回头。医生正在给他做“腰穿”，这是一种神经系统疾病常用的检查和治疗方式。注入小董体内的东西被叫做“神经干细胞”，小董从医院医生那里知道，这是从脐血里提取的一种“神奇”的细胞，可以从脊柱“跑”到脑子里，去“修复”自己因为少年时鼠药中毒而受损的脑神经细胞，一旦那些本来受伤的神经细胞康复，他就不会再被多年的病症折磨了。

　　小董要求护士给他留下“干细胞”的包装，护士撕下一张说明书，小董看了半天，还是云里雾里。小董对“神经干细胞移植”的了解，主要来自这家医院的医生，医生在小董咨询时曾经提到，这个治疗不能保证每一个人都有效果，也就是说，小董接受治疗后，如果没有感觉到病情的好转，也是可能的，做还是不做，小董自己抉择。小董在接受“移植”之前签了一份“知情同意书”，医生没有把这份2张纸的同意书给小董留一份，小董依稀记得，上面讲到“神经干细胞移植”是一种正在研究中的新兴医疗手段，很多病人使用后证明可以改善病情，在河南做过临床试验，病人反映效果很好。

　　医生在床边像拉家常一样介绍这个手术，医生的态度胸有成竹，让小董打消了很多顾虑。医生告诉他，医院已经治疗了上千例病人，90%以上都有效果，医院的网站上有很多病人的故事，一些病人来自海外。这对小董有着强烈的诱惑。

　　“干细胞”注射入体内的过程要持续半个小时，之前，医生给小董做了局部麻醉，所以，他并没有感觉到难受。半小时以后，医生拔掉注射器，小董感到“兴奋”“美好”。这是2006年10月小董在青岛某医院干细胞治疗康复中心接受“神经干细胞移植”的情形，到现在他也没弄清楚，当时这种感觉到底是来自注入脊柱的干细胞，还是得到“治疗”后的心理安慰。

　　第二天下午，小董感受到了“效果”。自从十多年以前鼠药中毒留下后遗症以后，每天中午，小董会感觉浑身没有力气，眼睛发胀，身体酸痛，一定要睡上三四个小时，才能够缓解。可是这一天中午，小董感觉比平时精神好多了。小董有些发烧，大约是38度左右，头有些痛，四肢也痛，但医生告诉他，这是正常的反应，“细胞进入身体，总有个适应的过程”。对“效果”的满意冲淡了发烧的不适感，冲着这样明显的“效果”，小董决定再做一次治疗。

　　一个星期以后，还是同样的腰穿，半小时后，第二瓶“神经干细胞”注入了小董的身体。为了证实“疗效”，医生在治疗后的第二天下午到病床旁探望小董。平时在家，这个时候正是小董沉睡的时间，但这个下午小董和医生聊了很久，也没有觉得疲倦。这是一个惊喜，十多年来，小董尝试了无数治疗方法，他想，这一次，幸运终于降临在自己的身上了。

　　医生一般要求病人一个疗程做4-6次“神经干细胞移植”，一次的费用是1.2万元，小董钱不够，做完第二次治疗，他就回家了。除了期待，还是期待，回家以后，小董关注着自己的变化，他急切地盼望自己能像正常人一样生活。

　　几个月以后，乏力、疲倦、身体酸痛的症状并没有减轻，相反，小董开始常常感到头痛，有时候甚至痛得躺在床上起不来，在接受“神经干细胞移植”之前，他并没有头痛的毛病。小董打电话咨询给他做“神经干细胞移植”的医生，医生告诉他，头痛与治疗没有关系。小董对医生的态度很不满意，几次电话质问以后，小董认为医生有意躲避他，因为他每次打电话到那家医院，曾经治疗他的医生不是外出就是出差。

　　为了讨个说法，小董从陕西老家跑到医院所在的青岛，他先在一家网吧里联系到医生，医生告诉他此时不在医院，小董立即径直赶到医院，找到了声称不在医院的医生。医生的推搪让小董很失望，他一度肯定，这家医院和医生都是“骗子”。又过了几个月，小董在青岛见到一位接受“神经干细胞移植”的病友，病友亲身的经历说明这个治疗在病友身上出现了神奇的“效果”，小董陷入困惑之中：到底自己的不幸是“神经干细胞”无法治疗的10%，还是“神经干细胞移植”根本就是临床“实验”？

　　孤注一掷

　　“家里人坚决不同意，是自己孤注一掷，现在想来是太冲动。”小董说。

　　小董28岁，无业在家，无法工作主要是因为自己的病。14岁的时候，小董鼠药中毒，因为没有得到及时的抢救，留下了后遗症。

　　后遗症让小董从高二以后就不能继续学业，一边休养一边得到了大专夜校的文凭，但因为身体的原因，小董还是找不到一个合适的工作。“如果能让我好，我的寿命减上10岁都可以。”小董还年轻，他还有很多梦想，他唯一的敌人就是自己的疾病，治好它的愿望是如此强烈。自从学会了上网，小董开始在网络上了解自己的疾病，也开始了寻找治疗方法的漫漫征程。

　　“我是氟乙酰胺中毒，听说此药属于高毒神经类药，对脑干和中枢神经有强烈刺激。”小董在一家网站的论坛上介绍自己的病情，希望专业的医生能够帮助他。十几年里，小董在老家陕西的大小医院检查和治疗，但直到现在，还是没有确切的诊断。小董能熟练地说出七八种拗口的药物名称，这些药他都试过，还接受了高压氧舱治疗，针灸，中药，每次满怀希望的治疗以后，小董自己的判断都是“无明显改善”、“进步不大”。

　　尽管如此，小董还是没有灰心，就像一个沙漠里迷途的人，只要看到一抹绿色，就不会停下脚步。经常搜索治疗知识的小董在网络上认识了很多病友，2005年8月，一位病友“突然”告诉他，在接受了“神经干细胞移植”的治疗后，病情好了很多，病友劝说小董，也许应该试一试。

　　按照病友的介绍，小董登录一家“深圳北科生物科技有限公司(以下简称北科公司)”的网站，在这里，小董看到了让人振奋的新希望。网站上介绍了很多病人的故事，这些故事打动了小董。

　　一个故事是，病人是美国佛罗里达州人，病情是“C5-C6不完全的脊柱损伤”，也就是高位截瘫。2005年接受神经干细胞移植后，“他的肌肉变得更持久有力，可以站在双杠中超过十分钟而不痉挛。双手都可以伸开，左手比右手要灵活一些。腿部，脚部及背部都能感受到冷和热，之前这是不可能的，同时背部和腿也能排汗，双腿可轻而易举抬起再将脚靠到身体，双腿比治疗前有力并且可伸展再缩回。”

云帆风影

　　“外国科学多么先进，外国人都来这里治，我觉得应该是真的。”这是小董的第一个判断。

　　网站上还介绍了一个山东的病人牛某，故事描述他是一名脑外伤后遗症患者，在接受神经干细胞移植后，病情改善明显。小董在网络上联系到牛某，咨询了很多问题。牛某告诉小董，在青岛一家医院接受治疗后，自己的病情的确改善了很多，效果很好。牛某提及的青岛这家医院是一家二级甲等医院，医院内的“青岛某医院干细胞康复中心”是北科公司与这家医院合作成立的治疗中心。

　　“我开始也以为他是个托儿，但后来我觉得他是真的。”通过病友的故事，小董开始相信这个神奇的治疗。

　　小董专注地搜索有关神经干细胞移植的信息，他发现全国很多医院都开展这项治疗，他打算选择北京一家医院，因为是“国家医院”。小董经济拮据，咨询后他放弃了这个选择，这家医院治疗按疗程收费，一个疗程费用是4万多元，而青岛那家医院的治疗是按次数付费，一次治疗费用1.2万元，治疗的次数病人可以选择。

　　小董决定选择去青岛，试一试这个先进的治疗方法，但他的决定遭到父母的强烈反对。反对的原因一是费用太贵，二是父母不信任这家医院。父母向家住青岛的亲戚打听，亲戚说，这家医院是当地人也不愿意去的小医院，而青岛市里有名的大医院，都没有开展这项治疗。小董没有理会父母的阻拦，虽然他自己也不是十分清楚“神经干细胞移植”究竟是一个什么样的治疗，但病友们的故事还是促使他决定“孤注一掷”，“死马当作活马医”。

　　搏一次

　　多数病人和小董一样，抱着“死马当作活马医”想法接受“神经干细胞移植”，这一点，同样与北科公司合作的浙江某医院细胞治疗康复中心里，一位医生毫不避讳谈起病人的这种心思。“因为脑瘫之类是没有办法的，瘫了就瘫了，只能做一些康复。现在有干细胞治疗，可能进步很小，至少多一次机会，多一份希望。”

　　浙江那家医院细胞治疗康复中心的护士服务台上方，悬挂着一面红色锦旗，上面写着：“Thank you for giving me a new life and hope(感谢你给了我新的生活和希望)”，赠送者是一位来自美国的病人。徐医生很乐于介绍曾经和正在这家医院接受“神经干细胞移植”的病人的情况，用来说明“神经干细胞移植”是一种正在被国内外病人接受并获得很好效果的治疗方法。

　　位于这家医院20楼的“细胞治疗康复中心”，10多间VIP病房已经住满外国病人，走廊里穿梭的都是金发碧眼的西方人，医生介绍，正在接受治疗的外国病人住在两个楼层的病房里，多数来自匈牙利，也有来自罗马尼亚、美国、泰国、英国的病人，总共20多名。这里是杭州市工业集中的城区，外来务工人员多，但外国人却不多见。4年前，这里还是一家妇幼保健院，当地人都把这里当作生孩子的专科医院，因为“神经干细胞移植”的巨大吸引力，世界各地的病人奔向这里。

　　Linda是一个10岁的匈牙利小姑娘，她的老师带着她和其他两名小病人，一起来到这里，接受“神经干细胞移植”。Linda是脑瘫患者，到目前为止，传统的医疗技术无法治愈脑瘫，Linda听说中国开展的“神经干细胞移植”治疗以后，家人决定让Linda到中国来试一试。做完康复训练，Linda的午餐是外卖的必胜客匹萨，在医院里，Linda不得不努力适应跟自己家乡完全不同的生活环境，但这些都不重要，Linda和她的家人都期待着，跨越万里的就医之旅，能够给她带来康复的希望。

　　同样是匈牙利来的另一个家庭，因为2岁的孩子患脑发育不全到中国就医。一个疗程“神经干细胞移植”对外国病人的收费是2万美元左右，病孩的父母只有普通的收入，2万美元的治疗费用和来到中国的花销，对他们来说是一个不小数目。“当然很贵！”夫妻俩不会英文，他们的匈牙利老乡充当翻译，扬起眉毛说。夫妻俩认为康复师用来给孩子做康复训练的充气气球不错，想买一个带回匈牙利，护士告诉他们大约需要1000元人民币，夫妻俩因为价格昂贵放弃了。不过，只要孩子能够有细微的进步，对于父母来说都是惊喜，“以前他的双手抓得很紧，现在可以放松一些。”父母描述在接受了一个疗程“神经干细胞移植”后孩子的变化，他们期待着，还有更多的惊喜在前方等待着他们。

　　奇迹还是冒进？

　　青岛的牛某认为自己就是受惠于“神经干细胞移植”的幸运儿。牛某7岁时因为严重的脑外伤留下了后遗症，说话口齿不清，肌肉张力高，行走困难。牛某和小董一样，为了治疗后遗症试了不少方法，做得最多的是针灸，但却没有什么效果。

　　“我们也是没有办法去试试，既然有了治疗方法，就要赌一回。”牛某在当地报纸上看到了“神经干细胞移植”的新闻，咨询以后，牛某住进了青岛某医院，“将来有可能让桑兰站起来，他们的介绍是这么说的”，“就算没有效果也不会有副作用的”，医院的介绍给牛某很大的信心。

　　住院一个星期以后，医生告诉牛某，给他专门生产的“神经干细胞”从沈阳的生产基地空运到了青岛。牛某看到一个小拇指大的药瓶，里面盛装的液体，就是将要给他带来新希望的神奇“神经干细胞”。半小时的腰穿注射以后，医生要求牛某平卧6小时，到晚上，牛某下床。“奇迹”就在这一刻发生，他的脚后跟能着地了，这对于牛某是一个巨大的改变，过去，他走路“像跳芭蕾舞”。

　　带着惊喜，牛某一共做了4次“神经干细胞移植”，花费大约是5万元。牛某身上发生的变化，让医院很高兴，不仅把他描述治疗效果的博客文章挂到医院网站上，出院一段时间以后，医院还把牛某请回医院与病友交流。

　　不过，牛某在接受“神经干细胞移植”后身体的改变不止这些。“只不过现在也不知起什么作用，一只脚在自己动”，“去年腰还直晃”，牛某发现了这些异常的现象，但他还是朝好的地方想：“估计可能是细胞在里面活了，身上不由自主地活动。医生也说不清，不过都觉得肯定是好事，因为它自己在动，估计肯定是细胞在里面生长。”

　　“我盼着早日康复。”牛某说，这也是所有接受“神经干细胞移植”病人共同的强烈愿望。北科公司和与之合作的医疗机构，都在努力证实“神经干细胞移植”的安全和有效，浙江那家医院细胞治疗康复中心姓史的主任说：“我母亲也接受了移植，如果不是安全的，我怎么会让自己母亲也做呢？”

　　但来自医学界和科学家对“神经干细胞移植”应用于临床治疗的质疑之声，恐怕只能给牛某们的期待浇上一盆冷水。“这是一种应激反应。”记者将牛某的情况告诉周长福，他是中国科学院上海生理研究所神经生物学专业的专家。周长福认为，牛某身上出现的效果很可能是“应激反应”，没有任何根据证明是干细胞的修复效应，因为目前还没有实验证据可以证实，神经干细胞可以治疗这样的神经损伤。

　　“神经干细胞移植应用于临床，还很遥远，至少不是未来几年里能够实现的目标。”周长福认为，因为很多神经干细胞移植的关键难题，连实验室里的动物实验都还没有解决。他严肃地把“神经干细胞移植”应用于临床的行为，叫做“胡扯淡”。

　　“我也赞同周长福的说法。”中国科学院上海生命科学研究院生物化学与细胞生物学研究所神经发育学专家景乃禾，在接受记者采访时这样说，他是国内神经发育专业的权威专家。

　　小董他们抱有巨大希望的干细胞移植的临床治疗，眼下正处于科学与不科学、规范与不规范之间的“灰色地带”。  

尽管科学家对神经干细胞移植将来应用于临床充满乐观的信心，但他们不得不面对的是，距离成熟的临床应用，还很遥远。

　　撰稿／黄 祺(记者)

　　它的确神奇

　　与国外病人相比，小董接受“神经干细胞移植”花费的2万多元钱，不算太多，但这笔钱对于小董和他的家庭，已经是巨大的开销。现在，病情没有好转，小董很想知道自己到底是上当受骗，还是“药不对症”，他努力地在网络上搜索信息，最后发现，没有人能给他一个满意的答案。

　　“神经干细胞移植”究竟是一种怎样的治疗技术？记者以咨询者的身份来到“浙江某医院细胞治疗康复中心”，一位姓马的医生介绍说：“随着科学的发展，干细胞可以修复大脑中受到损害的细胞，我们移植的是神经干细胞，修复受损的脑组织，帮助功能的恢复。”

　　让非生物或者非医学专业的人理解“神经干细胞”已经足够困难，更别说再加上“移植”“修复”一类的专业术语，事实上，即便是专业学者，对“神经干细胞”的了解也不多，它的发现，仅仅只有10多年的历史。

　　1989年以前，没有人相信有“神经干细胞”这个东西的存在。在此之前，造血干细胞早就被发现，1950年代，科学家已经发现通过移植骨髓，病人获得造血干细胞后可以治疗造血功能障碍等疾病，过去，白血病、地中海贫血等被认为是不治之症，通过骨髓干细胞移植，这些疾病的患者得到生的希望。

　　而大脑中的“神经干细胞”一直没有被掀开面纱，所有人都认为神经元是不可再生的，如果神经细胞受到损伤后死亡，就不会像血液细胞一样得到新生力量的补充，只有“神经胶质细胞”来补充空缺。“神经胶质细胞”是不能替代原来神经细胞的功能的，所以一旦神经细胞受到损伤，就像脑瘫病人的大脑中出现的情况那样，损伤的神经细胞是不能自我修复的。受损的神经细胞就像一根竹竿，一旦断裂，就无法恢复到原来的样子，就算我们用胶水把竹竿接起来，它也无法重生。

　　这种看法在1989年被打破，一位科学家提出“神经干细胞”的设想，后来经过各国科学家的实验，到1990年代初期，科学家们认定神经干细胞的确存在于成年动物脑和脊髓内的大量区域。

　　

云帆风影

这个发现让人振奋，它意味着，就算是神经细胞受损，人体也能自己把它修复成原来的样子，过去我们看到神经系统疾病无法恢复，可能是因为这些天生的修复材料不够多。完成这个修复工作的，就是“神经干细胞”，它像“母亲”，能够按照需要“生育”出神经细胞，并且在受损部位让神经细胞死而复生。只要我们对“神经干细胞”足够了解，就能够在人工的干预下，“制造”足够多的“神经干细胞”，然后根据需要，把它送到该去的地方，这样，很多神经系统的顽症，就可以迎刃而解了。

　　世界各地的科学家开始投入到这个充满诱惑的研究领域，在中国，2001年立项的国家重点科研项目973计划里，也把神经干细胞研究作为课题，北京大学和中国科学院上海生命科学研究院的两位科学家主持开展科研。

　　实验室中，研究者已经发现神经干细胞的巨大“潜能”。从胚胎或者成体细胞中能够分化出神经干细胞，如果在实验室中创造出特殊的环境，那么这些分化出来的神经干细胞能够诱导发育成为神经细胞，接着，有科学家继续实验，在动物实验中发现，如果把那些通过特殊方式分化出来的神经干细胞移植进动物的身体，它们能够“长”出神经细胞，“修复”受损的神经细胞。

　　这就是“神经干细胞移植”的理论基础，也就是说，把神经干细胞“种”进大脑，让它去需要的地方“修修补补”，是有可能的，这也是主张“神经干细胞移植”可以用于临床的的理由。不过，上面出现的情况，还是在实验室中发生的“故事”，由于关键技术存在的不确定性，没有严谨的科学家敢把这个看上去“成熟”的过程用在人的身体上，即便存在个别的人体临床试验，也没有科学家声称已经得到了可靠的结果。

　　诺贝尔奖提前到来？

　　“明天的治疗，今日享用”——在青岛某医院干细胞治疗康复中心的宣传资料上，有这样一个响亮的口号，但严谨的科学家表示，幻想“明天的治疗今日享用”实在是太早了，神经干细胞移植关键的难题还没有解决，只要这些关键难题没有解决，临床治疗的安全和效果就无从谈起。

　　最重要的难题有两个：神经干细胞能否分化为一定纯度的神经细胞？神经干细胞“移植”进大脑后，能不能在正确的位置“长”出神经细胞来，而且这些“长”出来的神经细胞能不能长期“存活”。

　　又是艰涩的专业概念。

　　让我们来想象一下。人的胚胎就像一颗种子，将来是会变成一个人的，这颗种子里包含了无数更小的种子，有的种子将来长成皮肤，有的长成肝脏，有的长成血液，还有的长成神经细胞。神经干细胞，就是将来神经元和神经胶质细胞的“母亲”。最早科学家对神经干细胞的研究，是从胚胎里寻找它的，这比较好理解，因为只要把种子放在合适的环境中，可以看到，有一些细胞将来就是变成了神经细胞。

　　从胚胎中得到神经干细胞看起来更加可靠，一般有两个途径：一个是从流产胎儿的中枢神经系统中分离出来，一个是从人的胚胎干细胞中诱导分化出来。不过，由于宗教和伦理的限制，这样获得神经干细胞的途径在很多国家被禁止。

　　幸好，通往罗马的路不止一条，科学家们发现神经干细胞不仅存在于胚胎，而且还存在于骨髓、脐血里，如果从这些途径获得神经干细胞，就不存在宗教的禁忌。于是，很多研究者把注意力集中在非胚胎的神经干细胞来源上。

　　但问题是，脐血中神经干细胞的含量很小，如果我们要利用它，就必须分离、纯化和扩增，就像要从矿石中筛取钻石一样。但到目前为止，科学界还没有成熟的分离、提纯和扩增的技术平台，没有公认的标准来规范这个过程。也就是说，没有人知道哪种分离方式最好，纯化到什么程度才可以用于移植，扩增后的干细胞要达到哪些指标才是“合格”的。

　　至于第二个难题，就更加复杂。动物的大脑是一个精密到无法想象的“黑匣子”，至今人们对大脑的了解不多，神经系统是传递信号的“道路”，一个挨着一个的神经细胞巧妙而精确地传递电信号，才让我们在看到台阶时知道要抬腿。就算我们解决了第一个难题，把“安全”的神经干细胞移植进大脑，这些干细胞能不能到达需要修补的地方？到达以后能不能像其他神经细胞一样传递信息？这些，都没有确定的答案。

　　除了上面两个难题，还有很多临床使用的细节无章可循，比如移植的方法、途径、佐剂、适应症等等。而且，神经干细胞治疗的效果评定，也是正在研究中的课题。“如果有人解决了这些难题，一定能得诺贝尔奖。”周长福说。很多科学家都致力于解决这些问题，尽管科学家对神经干细胞移植将来应用于临床充满乐观的信心，但他们不得不面对的是，距离成熟的临床应用，还很遥远。

　　神经干细胞“亢奋症”

　　在专业研究人员眼里，神经干细胞移植离临床治疗还有很长的距离，但那些支持临床应用的人，却只拿“效果”说话。“我们用了这么几年以后，应该说没有出现毒副作用。”“我们治疗的脑瘫病人90%以上都有效果。”在一家开展神经干细胞移植的医院里，医生这样说。浙江某医院干细胞治疗康复中心的史主任说，他们只想做“实在的工作”，不追求商业目的，所以一直没有过多宣传，但他还是忍不住告诉记者：“我们很多治疗病例，可以说是世界首例的。”

　　“一项新技术在没有被证明确实有疗效之前，就不能在临床上应用，最多只能用来做临床试验，那样的话不仅要病人知情同意，还不能收取费用，并必须遵循有关临床试验的法规。”方舟子在接受记者采访时表明了他的观点。与他的态度类似，暨南大学附属医院一位康复科医师，也非常不赞同把“神经干细胞移植”应用于临床。

　　对于“神经干细胞移植”应用于临床的质疑之声，从来没有停歇过，但这项备受争议的治疗技术，还是蓬勃地发展了起来。

　　2005年，国内几家医院开始开展神经干细胞治疗，曾经在医学界掀起热烈的讨论，北京宣武医院是国内神经科实力非常强的医院，医院的几位医生对“神经干细胞移植”应用于临床发表了看法，并发表在《健康报》上。

　　记者联系到当年这个报道中反对“神经干细胞移植”临床应用的专家，他们的观点至今没有改变。

　　“据我掌握的资料神经干细胞移植在帕金森氏病等治疗方面有一定的效果是指可以产生多巴胺类物质。至于对诸如运动功能、言语功能、认知功能、吞咽功能、二便功能等最重要的神经功能的恢复方面，至今我没有发现国际上有任何循证医学的证据表明神经干细胞‘移植’是有效的。”其中一位神经康复专业的医师这样答复。

　　他说：“其实，神经干细胞的实验室培养技术早已过关，直接把它‘输入’回血管内或注射到局部组织内也极其简单。稍微有点设备就可以‘扩增’出来。利用人们的‘期望’和‘信任’，大肆宣扬‘治疗效果’，我认为是极其不负责任的，至少是没有任何科学依据的(不是多中心、大样本、随机对照的盲法研究的结果)。个别人可能就是被‘经济效益’驱动的。我们接收了一些‘移植后’的患者，没有一个是真正‘有效’的。因为是‘自愿’的，也就没有人要‘讨说法’。”“一个愿打，一个愿挨，奈何？”-     .
http://q.sohu.com/forum/7/topic/45455510

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[机构]海淀医院功能神经科失眠中心、中关村医院激光整形美容中心和北京军区总医院激光美容整形中心违法广告被曝 阳光志愿者 红叶 2010-08-09 添加

海淀医院功能神经科失眠中心、中关村医院激光整形美容中心和北京军区总医院激光美容整形中心违法广告被曝。广告标题：迎“三八”专家列出“美丽清单” ，涉及内容：美容整形，刊出电话：62583054 62628111 62628666，刊出网址：----- 刊出单位/地址：海淀医院功能神经科失眠中心，中关村医院激光整形美容中心，北京军区总医院激光美容整形中心。
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• 公告单位：北京市卫生局
• 信息来源：北京市卫生监督所日常监测违规发布的医疗广告(第001期)
• 发布时间：2009年03月06日
  

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中国干细胞疗法让人伤心欲绝
HONG KONG (Reuters) - Chinese hotel manager Hong Chun had trouble using chopsticks after a minor stroke and sought treatment at a large Shanghai hospital where doctors injected what they said were donor stem cells into his spinal cord and buttocks, according to his father and cousin.香港(路透社)——中国酒店的经理洪淳轻微中风,用筷子有困难,寻求治疗,根据他的父亲和堂兄陈述，上海医院医生在他的脊椎和臀部注射他们所称的供体干细胞进。Leaving hospital the next day, Hong, 27, fell so ill he had to be taken off the train and rushed to another hospital.第二天,离开医院,27日,洪淳出现头晕和恶心的症状，他只好走下火车,到另外一家医院治疗。But doctors were unable to save him and he was declared brain dead before dying a month later.但是医生无法拯救他,他被宣布脑死亡一个月后离世。Desperate for help, patients with incurable diseases are admitting themselves into hospitals in China for "stem cell therapies" but experts say such treatments are backed by little or no scientific evidence and are at best experimental.监管空白的存在,客观上鼓励了医院“大胆尝试”。“干细胞疗法”,但专家称该治疗方法是以很少甚至没有任何科学证据和最好的实验。Some of these cases involve large general hospitals where patients pay thousands, even tens of thousands, of dollars for treatments that are advertised online.这些病例都大型综合医院里病人成千上万,甚至支付数万美元的治疗,在线广告。Patients have come away with little or no improvement and a number have died, according to patients, doctors and relatives of patients who spoke to Reuters.病人病情很少或没有改进伴随大量死亡,根据患者,医生和病人的亲戚告诉路透社记者。Hong paid 30,000 yuan ($4,800) to the Chinese army's 455 PLA Hospital in Shanghai for the treatment last year, according to hospital receipts seen by Reuters.洪淳付了30000元(4800美元)在上海中国人民解放军455军队医院进行治疗,根据医院去年收据路透社记者所看到的。His father, Hong Gensho, travelled to Shanghai to seek an explanation.他的父亲,洪先生,Gensho前往上海寻求一个解释。But hospital administrators told him his son didn't die in their hospital, paid him 80,000 yuan and told him not to pursue the matter.但是医院管理者告诉他他的儿子没死在他们的医院,给他80000元,告诉他不要追求的事。"I am miserable, it's like my son was worth only 80,000 yuan.“我很可怜的,就像我儿子在价值只有80000元。It's not about money.这不是钱的问题。Our human rights, our place in this society, are not respected.我们的地位决定我家在这个社会不被尊重。I am devastated.我真的很伤心。If he hadn't sought treatment, he would not have died," said the elder Hong, 61.如果他没有寻求治疗后,他就不会死,”61岁的洪先生说。"I can't get my son back, but people must know about these stem cell therapies and no one must be deceived."“我不能把我的儿子回来,但是,人们必须知道这些干细胞治疗,没有人要受到蒙蔽了。”LACK OF SCIENTIFIC EVIDENCE缺乏科学证据Experts have raised the alarm on patients turning up at clinics and hospitals in China, Mexico, India, Turkey, Russia and elsewhere for stem cell therapies that have not undergone clinical trials and which are not recognized as standard treatment.专家提出了报警对病人出现在诊所和医院在中国、墨西哥、印度、土耳其、俄罗斯和其他干细胞治疗,未经临床试验并没有公认的标准治疗。Patients often pay fees of $20,000 and more for such therapies after exhausting conventional treatments.病人经常费用支付20000美元,但是更多的常规治疗,这些治疗方法。"Stem cell tourism is regarded as ethically problematic because patients receive unproven therapies from untrustworthy sources," Dr David Resnik at the U.S. National Institute of Environmental Health Sciences and Zubin Master at the University of Alberta in Canada wrote in a paper published in the journal European Molecular Biology Organization.“干细胞旅游作为伦理问题的病人接受治疗因为未从不能信任的来源,”大卫Resnik博士在美国国家环境卫生科学研究所,硕士Zubin大学在加拿大亚伯达省写了一篇发表在《欧洲分子生物学组织。Echoing the same concerns, Dr George Daley at the Harvard Stem Cell Institute and Harvard Medical School said he was swamped by enquiries from patients asking about therapies in China and Brazil for diseases from Alzheimer's to spinal cord injuries.与相同的问题,乔治·戴利的哈佛大学博士干细胞研究所和哈佛大学医学院说他被询问询问病人治疗在中国和巴西的疾病,从阿尔茨海默氏病脊髓损伤。"What I'm talking about are the less legitimate treatments that have not even undergone clinical trials but are directly marketed therapies...“我说的都是缺少合法性的治疗,甚至还没有经历了临床试验,但直接用于临床治疗…We really have no idea how to use stem cells for these treatments," Daley told Reuters.我们真的不知道如何使用干细胞,这些治疗方法,”戴利告诉路透社记者。When contacted by Reuters, a director at the PLA 455 Hospital, who declined to be identified, said: "There are always good and bad outcomes.路透社,当接触的一位导演,中国人民解放军455医院不愿透露姓名的,说:"总有好的和坏的结果。No therapy can guarantee success to everyone...没有治疗可以保证成功到每一个人…Besides, you don't have a better alternative.除此之外,你没有一个更好的选择。"As for patients dying, all deaths must be investigated.“至于患者死亡,死亡人数的行为,必须予以追究。What caused the death?什么导致了死亡?If our treatment caused the death, the patient (relatives) can seek redress.如果我们的治疗,病人致其死亡(亲戚)可以要求赔偿。If it is a death caused by old age and sickness, then there is nothing I can say."如果它是一个年老的死亡和疾病引起的,就不会有我能说的。”China's Ministry of Health did not respond to questions from Reuters on stem cell therapies being offered in the country.中国卫生部没有回应路透社提出的中国为什么允许干细胞治疗问题。VICTIMS ARE THOSE FACING DEATH受害者是那些正面临死亡Suffering from late-stage liver cirrhosis caused by a lifelong hepatitis B virus infection, Fan Hongkun was led to believe her body would spontaneously grow a healthy liver once stem cells were transplanted.患有晚期肝硬化造成终生的B型肝炎病毒感染、范洪坤被广告宣传相信干细胞移植能让她的身体自然生长一个健康的肝。"We saw the therapy advertised online and talked to the doctor over the phone.“因为我们看到了在线的广告疗法并给医生打电话。He said stem cells were like seeds, after being planted on a liver, they grow, divide and spread and finally form a healthy liver," said Fan's son, Zhou Junjie.他说,干细胞就像种子,移植到肝上、种子长不停地繁殖,最终形成一个健康的肝脏,“范洪坤的儿子周俊杰说。Fan, 63, was so convinced, she admitted herself into Beijing Military General Hospital, whose website still carries information on the stem cell therapies it offers.范,63岁，她确信北京军区总医院网站上宣传的干细胞疗法能治疗她的病。"My mother said the PLA (Chinese army) doesn't lie.“我的母亲说中国人民解放军(中国军队)不会说谎。That's why she trusted them," said Zhou.这就是为什么她信任他们,”周说。Doctors there took her off the drug lamivudine for four weeks to "prepare her for the stem cell therapy".医生们让她停止服用药物拉米夫定四个星期“准备为她干细胞疗法”。But she fell into a coma before doctors could treat her.但她陷入昏迷之前,医生可以帮她治疗。Sold under the brand Epivir by GlaxoSmithKline Plc, lamivudine minimizes liver damage by blocking the hepatitis B virus from replicating.在市场上销售的品牌Epivir葛兰素史克,拉米夫定使肝损伤,通过阻断乙肝病毒的复制。Fan's family learnt later from other doctors that she suffered a sudden surge of the virus after she stopped her medication, which pushed her into a coma and killed her.范的亲人通过其他医生了解到,停止服用拉咪呋叮加重了她的病情并导致她去世。According to documents seen by Reuters, her family sued the hospital, but the case was dismissed by a Chinese court.根据路透社记者所看到的文件,她的家人起诉医院,但案件由中国法院驳回。When contacted, a doctor at the hospital, who declined to be identified, said the entire procedure to transplant stem cells into a patient's liver takes only a day.记者联系上这家医院,一个不愿透露姓名医生说，,移植干细胞到病人的肝一个人只需要一天。"We extract the patient's bone marrow cells and isolate the stem cells, which are then inserted into the liver," said the doctor.“我们提取患者的骨髓细胞和隔离干细胞,然后插入到肝脏,”医生说。"...We extract bone marrow cells in the morning and in the afternoon we inject them (stem cells) into the liver.“……我们提取骨髓细胞在早上和下午我们将它们注射(干细胞)到肝脏。Yes, all it takes is a day.是的,所有需要做的是花一天的时间。Very fast."非常快。”Advertisements for these treatments remain on the hospital's website.这些治疗的广告留在医院的网站。In Ireland, many patients have returned from treatments abroad with no improvement, but they are less willing to talk.在爱尔兰,许多患者治疗在国外回来没有改进,但他们也不愿意说话。"Virtually none will go on record to state they have been conned.“实际上没有人会继续的纪录表示他们已经之中。This is mainly because many patients have serious immediate health concerns and they need to focus on that," Stephen Sullivan, chief scientific officer of the Irish Stem Cell Foundation, told Reuters.这主要是因为很多病人有严重的健康问题,他们立即需要集中精力,”首席科学家斯蒂芬·沙利文爱尔兰干细胞基础,告诉路透社记者。"Patients are also reluctant to come forward as they are embarrassed at spending lots of money against professional medical advice.“患者也不愿意站出来为他们花很多钱难堪与专业医疗咨询。Some patients will even claim improvement when there is no measurable improvement."一些人甚至宣称改进患者当没有可衡量的改善。"POTENTIALLY POWERFUL潜在的强大的Researchers believe regenerative medicine will be a powerful form of therapy in the future.研究人员相信再生医学将是一个有力的形式的治疗,在未来的。Stem cells are immature, master cells in the body that can grow into any kind of human cell or tissue.干细胞是未成熟的细胞在体内,主人可以生长成任何一种人体细胞或组织。Scientists are exploring how to use them to treat a variety of diseases and disorders, including cancer, diabetes and injuries.科学家正在探索如何利用这些来治疗各种疾病和神经紊乱性疾病,包括癌症、糖尿病及伤害。But for now, they stress that only one type of stem cell therapy has been proven to work.但是现在,他们强调,只有一个类型的干细胞疗法已经被证明能够工作。"Only bone marrow transplants for diseases such as leukemia, lymphoma are backed by solid evidence and are well-established clinical procedures.“只有骨髓移植疾病,如白血病、淋巴瘤是确凿的证据和是信誉良好的临床过程。The others are not up to that level," said David Siu, clinical associate professor at the cardiology division of Hong Kong's Queen Mary Hospital.其他人还没达到这个水平,”大卫说小、临床副教授划分的香港心脏病玛丽女王医院。"There is evidence that certain stem cells can grow into new tissue but do they provide a therapeutic effect?“有证据指出,某些干细胞能发展成新组织,但他们是否提供一个治疗效果?We don't have the evidence yet.我们没有证据呢。Some are in clinical research."有些是在临床研究。”For the conditions highlighted in this article - disability from strokes and liver cirrhosis - experts say there are no proven stem cell treatments.本文突出残疾中风和肝硬化-专家说，目前还没有有效的干细胞治疗。。In their paper, Resnik and Master said while most countries had rules governing research on people and medical malpractice, they did not apply directly to stem cell therapy.在论文中,Resnik说,大多数国家有规定人的研究和医疗事故，他们不能直接用干细胞进行治疗。When doctors encounter strict regimes, they can simply move to other countries with more permissive legal environments.当医生遇到严格的制度时，他们可以简单地转移到其他法律环境宽松的国家。Experimental stem cell therapies, however, may be legitimately offered to patients, but these must be carried out within the framework of clinical trials that are approved by regulatory boards that ensure ethical standards are met.实验性干细胞疗法，但是，可合法地提供给患者，但这些必须的框架内进行的临床试验，经监管，确保道德标准得到满足。
"When experimental stem cell therapy is used on patients, it is not performed on an ad-hoc basis but within the framework of a proper clinical trial prepared beforehand," Siu said.“当实验干细胞疗法用于患者,但却不是一个特设的基础上进行的框架内,但一个适当的临床试验豫备,”小说。"It has to follow a rigorous methodology: what are the risks, what can and cannot be done?“这必须遵循严格的方法:什么是风险,什么可以做到,什么不可以做什么呢?If the results are negative, what are the rescue and safety measures?"如果结果是否定的，有什么救援和安全措施？”
Sullivan urged patients to be on the lookout for scams.沙利文提醒病人当心被欺骗。Suspicious signs include being asked for large sums of money up front, being told there are no risks, and being offered no post-therapy care.这些欺骗迹象包括被要求付出大笔的钱,被告知没有风险,并没有提供治疗后的护理。post-therapyPatients should be told how they will be treated, what stem cells are used and where they come from.患者应该被告知他们将如何治疗,干细胞的使用程度,他们来自哪里。They should not accept any therapy based on hearsay, or without the treatment being validated at least in part by peer review, he said.他们不应该接受任何治疗基于传闻,或没有治疗验证的至少部分地是由于同行评审,他说。Resnik and Master urged stem cell scientists, who have control over stem cell lines, to help stop these scams by not releasing such materials to doctors or clinics if they cannot produce proof of conducting a genuine clinical trial.Resnik和掌握敦促干细胞科学家,制止那些没有经过真正的的临床试验而进行的干细胞治疗。"This would ensure that the stem cells and other materials are going to be used in the course of responsible biomedical research, a legally sanctioned clinical trial or in responsible medical innovation," they said.“这将确保干细胞和其他材料将在生物医学研究,在合法许可的临床试验或责任重大的医学创新的,”他们说。

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