无论在职何国度，那些提供尚未证实的干细胞医治的诊所，常和卫生监管部门玩起猫捉老鼠的游戏
。然而意大利则颁布了干细胞医治官方处置方式，其卫生部长Renato Balduzzi颁布号令，对于32个身患绝症的病人干细胞医治能够持续进行，其中大部门是儿童，只管所涉及干细胞还未凭据意大利司法安全尺度造作
。
    3月21日，这种让人始料不及的决定吓坏了科学家，他们以为这种医治很危险，由于它从未经过严格的测试
。在米兰大学干细胞钻研者Elena Cattaneo看来，这就是点石成金式的炼金术
。
    该决定颁布是在接连数周的媒体压力要求出于同情赐与医治的情景下出台的，这一疗法是由Brescia-based Stamina基金会开发的，且在从前六年中历经数次不容
。此刻，病人在呼吁将这个医治遍及到所有身患无法治愈疾病的病人上
。数百人于3月23日在罗马进行抗议，蕴含一名身涂“pro-Stamina”支持标语的裸体妇女（下图）
。
 

    Stamina基金会总裁乌迪内大学的生理学家Davide Vannoni暗示，干细胞医治的宣传为其赢得9000名新患者
。他但愿能进一步批改司法，让他能够扩大医治
。一个月前，The Hyena电视节主张调查汇报称，身患绝症如脊髓性肌萎缩症的儿童的医治被拒，意大利商界名人呼吁放宽干细胞医治政策
。
    在帕维亚大学从事科学与司法的教授Amedeo Santosuosso暗示，在意大利，未经证实的医治可在将死之人无其他选择的垂危情况下酌情使用，且国度卫生服务是免费提供这种医治
。司律例定，卫生行政部门核准这种医治的质量，但某些条款不是很明确
。Stamina存有潜在问题，在Stamina基因会医治的案例中，没有明确批注医治是有效的，所以在他看来酌情使用是不合法的
。
    Vannoni暗示，他是于2004年在俄罗斯成功实现病毒引发的面瘫医治后开发了这种疗法
。他约请了俄罗斯和乌克兰科学家至都灵开发这种步骤
。此表，Vannoni称Stamina已经医治80个左右的病人，蕴含，帕金森病人、阿尔茨海默氏症以及肌肉萎缩的病人
。他并未公开利用骨髓间质干干细胞进行医治的了局等具体资料
。在他的打算中，从患者身上提取的细胞，经尝试室造就操作，最后注入患者
。
    Vannoni认可，他虽没有颁布，但这种步骤绝不是炼金术
。每次医治城市使用多种类型细胞来更换受损组织或排泄能削减炎症、抗习染的分子或推进血管成长
。不论是什么病，某种类型的细胞将阐扬正确的成效
。
    2007年欧盟的一项律例曾要求，干细胞医治必须遵循药品安全性和有效性律例
。Vannoni将他的尝试室搬至圣马力诺共和国，在那里干细胞医治律例不是那么严格
。但他得的钻研受到都灵检察官Raffaele Guariniello的关注，凭据他调查得出结论：“Vannoni的尝试对公家是有害的”
。Vannoni暗示Guariniello借国际压力以阻止他在圣马力诺的工作，因而，他又搬至雅斯特，但是在这里Guariniello再次阻止了他的工作
。
    从那以来，Vannoni 迁徙至布雷西亚的公立医院
。去年5月，一个来自意大利的药品局(AIFA)、国际空间站( ISS)以及国度卫生部钻研所组成的代表团参观了布雷西亚尝试室，并报路了尝试室混乱情况，路德委员会做出如此评论重要基于信息不及、没有具体的操作规程、没有患者随访等
。
    患者和眷属起头求助于司法造度，以持续酌情使用这种医治
。很多法院得出的结论是，接受医治服务是病人的权势，医疗卫生必须提供这种服务，且在某些情况下，布雷西亚尝试室再次提供了细胞医治
。
一些被迫医治的了局仅颁布出了至今唯一的临床了局
。雅斯特Burlo Garafalo儿童医院的临床医生医治了5个带有I型脊肌萎缩症的婴儿，并于去年10月颁布了了局
。他们发现医治并未扭转疾病发展过程
。Vannoni以为医治失败是由于医生没有严格执行他所谓的鸡尾酒细胞疗法
。
    3月7日，当卫生部长Balduzzi授权为带有异染性脑白质营养不良致命疾病的三岁儿童持续医治时，这也批注干细胞是一个优良的尝试设施(GMP)
。与自己的监管机构对抗的Balduzzi这一做法激怒了科学家们
。蕴含Cattaneo 和Santosuosso在内的 13个学者给Balduzzi颁发了一封公开信，并忠告他这一做法的危险性
。
    罗马大学干细胞科学家Paolo Bianco参加签署了这封公开信
。他暗示这种授权糟糕透顶：“此刻部长在允许非GMP尺度，一个未经授权、未公开、未知的实际称为’医治’
。”
    Balduzzi这项法令有可能是他即将离肆意大利当局颁布的最后一项立法
？蒲Ъ业杆募倘握吣茏鹬谹IFA及其他科学机构
。AIFA 总裁Luca Pani回绝对该政治决定颁发评论，但暗示他的机构对峙关于布雷西亚干细胞造剂的安全性和有效性的申明，并暗示我们仍旧坚守这一禁令
。

【原文检索】
http://www.nature.com/news/stem-cell-ruling-riles-researchers-1.12678

Stem-cell ruling riles researchers
---Italian health minister’s support for a controversial treatment appals the country’s scientists.
Clinics that offer unproven stem-cell treatments often end up playing cat and mouse with health regulators, no matter which country they operate in. In Italy, however, one such treatment now has official sanction. The country’s health minister, Renato Balduzzi, has decreed that a controversial stem-cell treatment can continue in 32 terminally ill patients, mostly children — even though the stem cells involved are not manufactured according to Italy’s legal safety standards.

The unexpected decision on 21 March has horrified scientists, who consider the treatment to be dangerous because it has never been rigorously tested. In the opinion of stem-cell researcher Elena Cattaneo of the University of Milan: “It is alchemy”.
The decision followed weeks of media pressure to authorize compassionate use of the therapy, which was developed by the Brescia-based Stamina Foundation and has been repeatedly banned in the past six years. Now, patient groups are pushing for the treatment to be available to anyone with an incurable illness. Hundreds protested in Rome on 23 March, including a naked woman with pro-Stamina slogans painted on her skin.
Stamina Foundation president Davide Vannoni, a psychologist at the University of Udine, says that the publicity around the treatment has won him 9,000 new patients. He hopes that further modifications to the law will allow him to expand the therapy.

A month ago, an investigatory television programme, The Hyena, reported that children with incurable diseases such as spinal muscular atrophy were being denied supposedly important treatment, and Italian show-business personalities joined the call to relax rules on stem-cell treatment.

In Italy, the compassionate use of as-yet-unapproved therapies is allowed on an emergency basis for dying individuals who have no other options, and the national health service must provide them for free. The law requires that health authorities approve the quality of such therapies, but some of its terms are ambiguous, says Amedeo Santosuosso, a Milanese judge and a professor at the University of Pavia who specializes in science and law. “That has been the underlying problem in the Stamina debacle,” he says. “In the case of the Stamina Foundation therapy, there is no suggestion that it might be efficacious, so in my opinion compassionate use is not legitimate.”

Vannoni says that he developed the therapy after having successful stem-cell treatment for a virus-induced facial paralysis in 2004 in Russia. He invited a Russian and a Ukrainian scientist to Turin to develop the method and says that Stamina has since treated 80 or so patients — including people with Parkinson’s disease, Alzheimer’s and muscle-wasting disorders. He has not published the outcomes or precise details of his therapy, which uses the mesenchymal stem cells from bone marrow that differentiate into bone, fat and connective tissue. In his protocol, the cells are extracted from patients, manipulated in the laboratory and then re-infused.

Vannoni acknowledges that he has not published outcomes but says that the method is far from alchemy. Each treatment uses five types of cell, he explains, with their claimed characteristics tuned to replace damaged tissue or to secrete molecules that could reduce inflammation, fight infection or promote blood-vessel growth. ”Whatever the disease, one of the types of cell is going to have the right effect,” he says.

When a 2007 European Union regulation required that stem-cell therapies follow the same safety and efficacy rules as pharmaceuticals, Vannoni moved his lab to the republic of San Marino. “There, rules were not so strict,” he says.

But his work had drawn the attention of a Turin prosecutor, Raffaele Guariniello, whose investigations concluded that Vannoni’s operation could be “dangerous to public health”. Vannoni says that Guariniello marshalled international pressure to stop him working in San Marino, so he moved to Trieste, where he says Guariniello again stopped his work.

From there, Vannoni moved to a public hospital in Brescia. Last May, a delegation including representatives of the Italian Medicines Agency (AIFA) and the ISS, the health ministry’s national institute, visited the Brescia lab and reported chaotic conditions: ethics-committee approvals had been based on inadequate information, and there were no detailed protocols or patient follow-up, for example. The AIFA closed the lab, stating that the facilities could not be trusted to produce contamination-free preparations.

Patients and families turned to the legal system to allow treatments to continue as compassionate use; many of the courts concluded that it was a patient’s right to receive treatment and that health services must offer it, and in some cases the Brescia lab once again supplied cells.

Some of the compelled treatments led to the only publication of clinical results so far. Clinicians at the Burlo Garafalo Children’s Hospital in Trieste treated five babies with type I spinal muscular atrophy and published the results last October (M. Carrozzi et al. Neuromuscul. Disord. 22, 1032–1034; 2012). They found that “the treatment did not change the course of the disease”, says co-author Marco Carrozzi. Vannoni argues that the therapy failed because the clinicians did not use his exact cocktail of cells.

Setting himself against his own regulatory agencies, Balduzzi had earlier angered scientists when, on 7 March, he authorized continued therapy for a three-year-old child with the deadly disease metachromatic leuko¬dystrophy — provided that the stem cells were created in a good manufacturing practice (GMP) facility. Thirteen academics, including Cattaneo and Santosuosso, published an open letter to Balduzzi warning him of the dangers (see go.nature.com/pb1wdl; in Italian).

That authorization was bad enough, says Paolo Bianco, a stem-cell scientist at the University of Rome who co-signed the letter. “Now the minister is allowing the non-GMP version and saying that an unauthorized, unpublished, unknown practice is a ‘treatment’.”

Balduzzi’s decree is likely to be his last legislative act in Italy’s outgoing government, and scientists hope that his successor will respect the role of the AIFA and other science-based agencies. AIFA president Luca Pani declined to comment on the political decision but says that his agency is sticking to its statements on the safety and efficacy of the stem-cell preparations from Brescia. “Our ban holds,” he says.

Nature
495, 418–419 (28 March 2013) doi:10.1038/495418a