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死亡事件给非法干细胞诊所敲响了沉重的警钟  

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发表于 2010-6-26 13:44 |显示全部帖子
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近日,一名妇女在泰国一间私人诊所接受干细胞治疗后死亡。对此,业界人士呼吁病人避免在国外没有牌照的私人诊所接受未经检验验证的干细胞治疗。
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1 A3 u5 s, Y) ]& S验尸报告的结果显示,干细胞治疗几乎可以肯定杀死了上述这名罹患肾部疾病的妇女。研究人员发现在她的肾部、肝部以及肾上腺处都发现了奇怪的肿块的存在。
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7 y: c5 Z1 Q* |$ _1 ~病人患有什么疾病,她究竟接受了怎么样的治疗?$ o6 K" x& v$ j$ c
这名妇女罹患狼疮性肾炎,这种情况是由人体自身的免疫系统错误地攻击并破坏了肾脏而造成的。通常,病情可以由免疫抑制类固醇控制,但当该病不受控制时,她绝望了,于是便选择到位于曼谷的私人干细胞诊所接受治疗。
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, I! z1 }: r! N" W3 ]3 }; A( m干细胞如何治疗她的疾病?, U- `5 @2 |8 B; n
6年前,欧洲的诊所曾进行了一次合法的干细胞试验。试验表明,如果将罹患肾部疾病的患者自身的骨髓干细胞重新注入他们的血液,就可以起到一定的治疗效果。采用免疫抑制药物蓄意破坏人体的免疫系统后,在注入干细胞便可帮助重建和重新平衡免疫系统从而阻止它对肾部的攻击。50名受试者中接近三分之一在一年或以上病情复发,其中12人死亡。但令人惊喜的是,有三分之二的受试者初见成效,病情得到缓解。: Q6 N7 I7 ^; B  H5 R  L% q" l
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那么这位去曼谷接受治疗的妇女身上究竟发生了什么事情?6 {3 V7 g! [  ]$ Y2 {% B0 W
与欧洲的受试者所接受的将干细胞注入血液中不同,去曼谷接受治疗的妇女是将干细胞重复直接注入自己的肾部。治疗的目的似乎是希望干细胞能够直接修复她的肾脏,而不是重新调整免疫系统。; L/ \! i) j8 i6 _% {
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结果怎样呢?
7 f# W- D; z6 M5 @# ]这位妇女在接受干细胞疗法3个月后,病情开始恶化,于是她便去曼谷的Chulanlongkorn 大学医院接受透析治疗。随后,医生在她左肾处发现了肾脏肿块。干细胞疗法之后的11个月,由于肾脏衰竭她不得不做了肾脏切除手术。一年后,这名妇女死亡。9 e( b$ R/ y: H3 `

# s" i* N* l6 E5 V# \那么对她肾脏进行检查后能发现什么吗?
( ]& g8 Z: s3 a: y) a检查后发现,这名妇女体内接受干细胞注射的肾脏部位出现了奇怪的肿块和损伤,其后证明它们是骨髓和血管组织的混合物。此外,还发现她的肝脏和肾上腺处出现了相同的肿块。来自Chulanlongkorn大学医院的Duangpen Thirabanjasak的报告指出,这些肿块几乎肯定来自注射的干细胞。
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究竟所注射的干细胞有没有益处?6 f# q! R: `% J3 ^
没有。因为它们无法在血液中循环,它们无法重新平衡身体的免疫系统,从而停止对肾脏的攻击。对于这些肿块的其中一个解释是:肾脏已经严重受损并缺氧。被注入这个氧气“沙漠”后,干细胞似乎开始构建新血管从而为身体重建新的供应系统。也许这些新血管对身体有益,但没人知道究竟它们是否最终会变成癌性细胞。
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0 L/ r* y0 c6 n% \. o这种干细胞疗法以后还可以使用吗?
3 ^) m' J2 V% e7 t& }" n/ \在美国肾脏病学会杂志撰文补充上述观点的加拿大多伦多西乃山医院的Susan Quaggin指出,将干细胞直接注射入肾脏治疗很可能不会被考虑当作正当的科学试验。
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因此,没有必要恐慌,然后停止所有干细胞的试验?9 p. Q# T* e% Z, N: o0 L& k# n. f
Quaggin认为当然不应该这样做。所有合法试验必须事先获得批准,并接受严格监控,并且结果必须是接受同行评审然后才能发表出版。但她同时指出,泰国的干细胞疗法的结果又一次提醒我们,病人不应该拿自己的身体安全去赌博,不应该接受不法经营者的治疗。+ `" C+ f: p; W. ?

" R0 e# F, c: h“不幸的是,许多人对正规治疗感到绝望,而使事情更糟的是,病人在治病过程中花费了许多金钱。”Quaggin说。她敦促所有准病人都到国际干细胞研究学会的网站获取治疗建议。- K  @4 x8 c8 C6 r) a' ]7 C
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其他干细胞研究人员对此次事件有何看法?
7 \# I2 l3 U7 I6 w- B. Z“这次事件再次为我们敲响了警钟是,我们必须意识到进入临床试验的动物模型的数据必须绝对安全。” 伦敦大学的再生医学主任Chris Mason说道。
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" y% o; V- v, M“多年来我们一直警告说,这种事情可能会发生,” Advanced Cell Technology公司干细胞首席科学家Robert Lanza说道。 “我怀疑这仅仅是冰山的一角:还有其它危险的副作用还没有被确诊或报告给科学界。”+ ?; {3 k' n- L  ~" n9 |

7 s0 T( q2 q# z/ Y给予该名妇女治疗的公司现在倒闭了吗?
6 D2 Z& C% h5 f% h研究人员不知道到底是哪间诊所在2006年给这名妇女提供了治疗。但目前在世界各地的私人诊所都感受到了压力。哥斯达黎加一家细胞医学诊所最近被卫生部关闭了。去年,中国当局承诺打击国内提供未经检查的治疗的私人诊所。& D6 \8 ~- w, A& @) R" M$ t

6 X" G0 q. T- c1 C但干细胞疗法还继续吗?
/ E" b# x2 T/ D5 W8 ?9 E( s/ f的确如此。人们的共识是,这只是一个由非法诊疗所造成的危险。人们有信心,这次事件只是偶然性事件,大部分干细胞疗法是不可能造成如此严重的风险的。

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发表于 2010-6-26 14:58 |显示全部帖子
本帖最后由 camel_stone 于 2010-6-26 15:13 编辑 5 N& T# d+ ^1 L

; O6 s) B& y' E! M) n恰好昨天刚看到这个文章的全文(不是评论文章),看来我们的嗅觉还是很敏锐。& l% p" y; ^* L- p0 _% C
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首先我认为,这一病例的出现值得深思!通俗的说,干细胞治疗不能像打鸡血一样,干细胞不是鸡血,干细胞的应用应该有一套科学的规范!3 C. ~1 y2 W2 N. c6 S6 w6 q, ]

2 f$ c2 g# @4 m列提纲如下,待详细讨论3 I" {. F2 x& f- o
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干细胞治疗的风险有哪些?. ~9 B/ T$ ?* N+ M. B) l$ i& b
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干细胞治疗肾脏疾病的目的是什么?
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8 p! x/ ?7 T, N8 I& c1 J患者罹患的肾脏疾病是什么类型的?
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局部应用干细胞和全身应用有何区别?
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发表于 2010-6-26 15:15 |显示全部帖子
http://www.newscientist.com/arti ... nics.html?full=true
% g& q# ~8 v7 u% eNEWSCIENTIST HEALTH" |0 q/ S  a8 p2 j# A# O7 q
Death revives warnings about rogue stem cell clinics " D% S9 z: M# o- e6 ]( V
22:00 17 June 2010 by Andy Coghlan
6 u4 k; n- v* wFor similar stories, visit the Stem Cells Topic Guide $ g0 b$ `# J+ U
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The death of a woman after she was treated with stem cells at a private clinic in Thailand has reinforced warnings for desperate sick people to avoid "stem-cell tourism" – the gamble of undergoing untested stem-cell treatments in unlicensed private clinics abroad.6 a: t+ `6 f' }. ]
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Post-mortem results reported this week reveal that the stem-cell treatment almost certainly killed the woman, who had been suffering from kidney disease. She developed strange lumps in the kidney, liver and adrenal gland.
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- p4 i5 s. V4 Z- VSo what are the implications for stem cell research generally, and is it safe for clinical trials to continue? New Scientist has some answers.' j9 X3 n+ [( l4 n
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What was wrong with the patient, and what treatment did she receive?7 `1 k3 h+ i8 ?7 B$ v6 h
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She had lupus nephritis, a condition in which the body's own immune system mistakenly attacks and destroys the kidneys. Usually it can be kept in check with immunosuppressive steroids, but when these failed, the woman turned to a private stem-cell clinic in Bangkok.
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How would stem cells help?
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+ ?/ v$ w, i: L5 k- e( XBona-fide trials in European clinics about six years ago showed that some people with similar kidney disease benefited if stem cells from their own bone marrow were injected into their blood. The body's immune system was first deliberately destroyed with powerful immunosuppressive drugs, then the reinjected stem cells helped to stop the attacks on the kidney by rebuilding and rebalancing the immune system. About a third of the 50 recipients relapsed after a year or so, and 12 of these people died. But around two-thirds saw benefits, with some going into remission.
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So what happened with the woman who went to Bangkok?! T! m2 ]" L4 i

- J2 U. q8 {3 S( [1 w) l/ zUnlike the European trial patients, who'd had their stem cells injected into the bloodstream, the woman had her stem cells repeatedly injected directly into both her kidneys. The aim seems to have been to get the cells to repair the kidney directly, rather than retune the immune system.
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- p' S% {6 A. V$ gAnd the result?            
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8 n! n& e6 ^* s  \Three months after her treatment, her condition declined, and she went to the Chulanlongkorn University Hospital in Bangkok, where she received dialysis. Later, a kidney lump was identified in her left kidney; 11 months after her treatment, that kidney failed and she had it removed. Another year later, she died.+ i, [, {' i/ O
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So what did examination of the kidney reveal?
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At the injection sites, the woman had developed strange lumps and lesions, which turned out to be mixtures of bone-marrow and blood-vessel tissue. Similar lumps had also developed in the liver and one adrenal gland. A team led by Duangpen Thirabanjasak of Chulanlongkorn University Hospital report this week that the lumps almost certainly came from the injected stem cells.
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Did the injected cells do any good at all?' w$ n0 H4 H$ J
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No. Because they weren't circulating in the bloodstream, they couldn't rebalance the body's immune system to halt attacks on the kidney. One explanation for the strange lumps could be that the kidney was already heavily scarred and poorly supplied with oxygen. Injected into this oxygen "desert", the stem cells seem to have begun making new blood vessels to rebuild a new supply system for themselves. They were suspected to be benign, but no one knows whether they would have eventually turned cancerous.
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3 A8 p2 a. a! W) b- g5 @; OIs the case a one-off?            
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Susan Quaggin of the Mount Sinai Hospital in Toronto, Canada, and co-author of a commentary on the results in Journal of the American Society of Nephrology, says that treatment by direct injection of stem cells into the kidney is highly unlikely to be contemplated or undertaken in bona-fide scientific trials. "There's no scientific rationale for doing it that way," she says.
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So no need to panic then, and halt all stem-cell trials?
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! F) h  @0 g' t6 A0 B) A- [# C; RAbsolutely not, according to Quaggin. All bona-fide trials must receive ethical approval beforehand and are scrupulously monitored, and the results must be peer-reviewed for publication. But she says that the Thai results are yet another reminder that sick people should not gamble with their safety, and money, by turning to stem-cell tourism peddled by unscrupulous operators.
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, N7 o9 p; Y, z, z& G"The sad part is that many people are desperate, and what makes it even worse is that it costs lots of money," says Quaggin, who urges all prospective patients to access new advice on the internet by the International Society for Stem Cell Research, a body based in Deerfield, Illinois, which has also issued a set of guidelines for ethical stem-cell research.
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What are other stem-cell researchers saying?
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5 f( f' p) p& }$ G"It's a dreadful reminder reinforcing the absolute necessity for robust safety data in animal models before entering regulated clinical trials," says Chris Mason, director of regenerative medicine at University College London.
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9 j2 Q0 Z& i6 w) R3 T5 _2 g  h"For years we've been warning that this kind of thing was going to happen," says Robert Lanza, chief scientific officer at the stem-cell company Advanced Cell Technology in Worcester, Massachusetts. "I suspect this is just the tip of the iceberg: that there have been other dangerous side effects that haven't been diagnosed or reported to the scientific community."
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Is the company that treated the woman now closed down?& C4 F5 Q7 ~# ]" e9 h! q0 o+ a
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The researchers don't know which clinic provided the therapy in 2006. But private clinics around the world have recently come under pressure. A clinic run by Cell Medicine in Costa Rica was recently closed by the Costa Rican health ministry. And last year, Chinese authorities promised to clamp down on private clinics offering untested treatments in their country.
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. s6 r  {. q2 lBut the show must go on?          0 L) C0 X0 x$ J

8 i2 u8 \# U2 P) pIndeed. The consensus seems to be that this is a timely warning of the dangers posed by unregulated clinics. But there's confidence that this was a somewhat freak result, and that most stem-cell treatments under trial are unlikely to pose such serious risks.. t8 c' e( D* i/ G% N; w& k

' A; h0 z2 G/ M' s, v9 uJournal reference: Journal of the American Society of Nephrology, DOI: 10.1681/asn.2009111156
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发表于 2010-6-26 15:35 |显示全部帖子
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每次做治疗前和治疗后在心里都默默地祈祷,千万不要出问题啊,即使做完了,也不能如释重负,因为一段时间后,也许还会出问题。所以从内心期盼能出台一个东西,各方都能认可,我们只是按照这个东西做,每个环节都有质量标准,都有控制指标,能证明我们没有做错。即便是日后发生了上面类似的事件,也与我们没有关系,有专人来处理。那样也许是最理想的了。也许我们才能无顾虑的做临床与研究了。
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发表于 2010-6-26 16:20 |显示全部帖子
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发表于 2010-6-26 22:21 |显示全部帖子
干细胞被江湖游医拿来骗人,最终会败坏大家对干细胞的期待

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发表于 2010-6-27 09:06 |显示全部帖子
恰好昨天刚看到这个文章的全文(不是评论文章),看来我们的嗅觉还是很敏锐。
# |' U, W& l( C; C9 d4 C. M' w3 \4 B# x# v$ ]" ~
首先我认为,这一病例的出 ...# J8 N$ d+ U2 y- i% n5 U. k9 F
camel_stone 发表于 2010-6-26 14:58
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$ f2 m' m+ f1 S7 ~% E' t1 p干细胞治疗的风险:
+ ~: l; e: N5 k7 W; S1.动物源及伦理7 z/ B* i/ N. V2 o) D
2.支原体: i# ^& q) z4 s# N3 r6 S
3.凝血?过敏?* z' x/ u# e, _$ r# A
4.致瘤?

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发表于 2010-6-27 09:19 |显示全部帖子
本帖最后由 camel_stone 于 2010-6-27 09:21 编辑 9 r9 b; W0 a  g' K5 D
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干细胞治疗肾脏疾病的目的是什么?" k5 g- E; m$ q

4 A+ L. C" v, y6 g3 y6 h患者罹患的肾脏疾病是什么类型的?
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目的不外乎有两个,一是组织再生,一是免疫调节3 v1 Z4 D+ w% e! D
该患者是狼疮肾病,应该说,SLE是难治性的自身免疫疾病,导致的肾损伤也是严重的。
: r6 r; W* o. l应该说,干细胞本身的组织再生能力是有限的,国外有专家认为,干细胞的组织能力(organize)更为重要。
( i$ y8 o1 Q0 W( o, y那么,不是所有的干细胞都用免疫调节作用,研究表明,间充质来源的干细胞(mesenchymal stem cells)有重要的免疫调节作用,这一类细胞包括骨髓间充质干细胞、脐血间充质干细胞、牙源性间充质干细胞等。
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病中不堪劳累,明天继续讨论干细胞应用方式问题。
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发表于 2010-6-27 19:21 |显示全部帖子
干细胞治疗疾病要考虑很多因素,如:干细胞的质量、来源、应用方式、适应症等等;之前就有过报道,一名以色列的儿童应用流产儿的大脑中分离出神经干细胞,4年后,得了一种增长及其缓慢的肿瘤,叫glioneural neoplasm。可见我们对干细胞了解还很少。
% }0 w7 o, m* U% ^" y个人觉得我们目前的干细胞治疗,最好利用其分泌的细胞因子调动体内自体的干细胞发挥作用,不要太多期望其分化成我们期望分化的组织;首先,目前的证据基本是在体内的分化是很少的,其次体内的分化并不由我们控制,一旦出现我们不期望的分化,那可能会出大事,就如本病例肾脏部位出现了骨髓和血管组织的混合物。
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发表于 2010-6-27 21:36 |显示全部帖子
the results are terrible,but stem cell has efficient influence in many areas, many dead disease will be cured by this margic cells
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