American Institute for cancer: biologic therapies are still in the experimental stage | w | West cancer _ news
Legal evening news (reporters Li Shixiang), according to earlier media reports, revealed a Baidu search on "synovial Sarcoma" advertising messages, Wei Zexi tried a second in Beijing, armed police corps hospital known as the United States Stanford University Cancer immune therapy. After the spent more than 200,000 medical expenses, learned of this therapy in the United States has declared null and void is stopped in clinical practice. During this period, the tumor has spread to the lungs, Wei Zexi NET and was later certified dead.
Wei Zexi case will be present in "miles away" at Stanford University School of medicine, stir in the whirlpool. For this event at Stanford University School of medicine's attitude is "distancing". The legal evening news reporter 2nd repeatedly wrote to the head of the Stanford University School of medicine number of media, as 3rd, by late journalist had received stem cells at Stanford University biology and regenerative medicine spread official kelisituofu·wagehan reply. He told reporters that the Institute is not involved in the study, reported, but other departments may have similar research at Stanford University. His journalist contact Beiji·bahe of the College of communication and public relations Commissioner (Becky Bach). Wagehan also told reporters, "as far as I know, now Stanford has not carried out such research. ”
By night (app ID:fzwb_52165216) reporter then contacted Ms Beiji·bahe. 3rd at noon, about 12 hours after the messages are received, she replied. Becky later told law reporter, in order to verify the Stanford University School of medicine and Wei Zexi cases involving hospital partnership, they spent "some time". The final confirmation, as far as is known, Stanford has not and "Wei Zexi incident" involving any hospital. She also stressed that the Stanford University School of medicine who was not involved in the incident.
However by late journalist is of more interest, this is a kind of therapy? Is still in the clinical trial at Stanford University? And whether such therapies have United States eliminated? For such legislation later this reporter once again question the medical school, however, the media relations officer's reply is disappointing, the law late this morning in response to the reporter for her "we have no further comment," declined a further interview requests on the.
Stanford University School of medicine is still conducting a study of the CIK
Wei Zexi by accept of is DC-CIK cell immune treatment, according to media reported, the method of treatment principle for will patients body of two species immune cell--tree bursting cell (DC) and cell factor induced of anti cell (CIK) extraction out, training, and spread increased Hou again back lost to patients body, equivalent to increased attack tumor cell of "soldiers", to enhanced patients of anticancer capacity.
Law Reporter late in the Stanford University School of medicine clinical trials directory search only on the treatment of high risk blood cancer after transplantation of autologous CIK cell therapy. The research project started in May 2006, and officially ended in March 2011, has undergone phase I and phase II trials.
And the night (app ID:fzwb_52165216) journalists in the United States national institutes of Health's clinical trials Web site also found that, on September 12, 2005 to December 2012 last updated information, Stanford also was the "immunotherapy following transplantation of hematopoietic cell transplantation of CIK cells" in clinical trials, experimental phase one clinical testing, current state of the experiment as "unknown".
In addition, Stanford still has a CIK of clinical trial research underway, mainly related to myelodysplastic syndrome (myelodysplastic syndromes)/consolidation therapy for Myelodysplastic diseases Post T-PLANT injection in treatment of CIK cells in vitro. Registration time at the site of the project is June 21, 2011 and is expected to finish of the project for January 2018.
By late journalist to contact each of the three CIK cell therapy the main responsible of the project, but as of press time had not received any reply. Three of the principals from the school's Medical Center blood and marrow transplantation.
FDA: cell therapy in many cases did not meet the relevant standards prescribed by the law
Law later reporters found that these three CIK cell therapy research at Stanford University School of medicine, also from the United States food and Drug Administration (FDA) Regulation of the health sector. FDA media spokesman andelie·feisheer told later reporters, United States FDA for the transplantation, implantation or converted into the body of the human cell or tissue has certain regulatory framework. And human cells, tissues, and cellular and tissue-based products (referred to as HCT/Ps), the cell therapy under FDA supervision.
Fisher later told law reporter, because of biological complexity, lots of HCT/Ps needs to be assessed individually to determine the correct regulatory path. In many cases, patients with medical conditions to implement cell therapy do not meet federal regulations related to regulations and standards. These treatments have not been approved, but is still subject to government supervision, requires these products to be able to explain the pre market approval of its safety and effectiveness. And researchers conducting clinical trials unapproved drug product, need for clinical trial applications.
Tsinghua University Dr He Ting said in a media interview, DC-CIK therapy in the United States have gone through years of research, but the clinical trials in the United States almost all failed, have not been licensed. At present, the United States indeed have little DC-CIK for the treatment of cancer clinical trials, are the main force of this technology in China.
Famous medical college in Tsinghua University Professor thousand person plan, said Lin Xin, an expert in Immunology, there are currently no authoritative study has obvious effect of DC-CIK therapy, clinical trials in foreign countries have not achieved the desired effect. As for bad reasons of clinical trial results, currently there are no generally accepted conclusions. But in the United States, if there is no good clinical results, was not approved by authorities, so DC-CIK is not used in clinical treatment, only a small number of clinical studies.
United States National Cancer Institute: biologic therapies to treat cancer is still in experimental phase
United States National Cancer Institute (NCI) spokesman Mike law late reporters said in an interview, she was aware of Baidu search engine results and the promotion of this therapy provoked widespread concern in China. But NCI cannot be specific comments on the event.
However, he offered by night (app ID:fzwb_52165216) reporter displayed in the relevant background information on the cellular immune therapy for many cancer patients, biological therapies may be used to treat the cancer itself or with any other side effects of cancer treatment. Although the United States FDA has approved many forms of biological therapy, but other information on biological therapies for cancer patients is mainly through participation in clinical trials (research involving human experimentation) to get, are still in the experimental stage.
Biological therapy side effects are different because of the different types of treatment. Generally speaking, along with injection or implantation positions brought pain, swelling, redness, itching is the most common. But more serious side effects directed mainly at a handful of biological therapy. For example by immune response against cancer therapies can raise a range of flu-like symptoms, including fever, cold and weakness, dizziness, nausea and vomiting, muscle or joint pain, headache and occasional respiratory disorders. Biological therapy triggered immune system response will also be the risk of serious and even fatal allergic reaction.
United States released information also pointed out that the National Cancer Institute, cancer immunotherapy is in progress on long-term investments in basic research on the immune system, which continues today. Current research also includes why immunotherapy is not valid in some patients and other patients, this extends to more types of immune therapy in cancer treatment. (Reporter Li Shixiang)
Responsible editor: Chen yan SN225
Article keywords:Wei Zexi cancer
I want feedback
Save a Web page
Legal evening news
美癌症研究院：生物疗法依然处于实验性阶段|魏则西|癌症_新闻资讯
法制晚报讯（记者 黎史翔）据此前媒体报道，因为听信了百度搜索中关于“滑膜肉瘤”的广告信息，魏则西在武警北京总队第二医院尝试了一种号称与美国斯坦福大学合作的肿瘤生物免疫疗法。在花费了20多万医疗费后，才得知这个疗法在美国早已宣布无效被停止临床。这期间，肿瘤已经扩散至肺部，魏则西终告不治。
魏则西案件将本在“千里之外”的斯坦福大学医学院搅入漩涡中。而对于这一事件斯坦福大学医学院的态度是及时“撇清关系”。《法制晚报》记者2日多次致信斯坦福大学医学院多位媒体负责人，截止3日凌晨，法晚记者收到了斯坦福大学干细胞生物和再生医学院传播官员克里斯托弗·瓦格汉的回复。他告诉记者，该学院目前并没有从事报道中涉及的研究，但是斯坦福大学其他部门可能会有类似的研究。他推荐记者联系医学院传播和公共关系专员贝基·巴赫（Becky Bach）。瓦格汉还告诉记者，“据我所知，目前斯坦福大学并没有进行这类相关的研究实验。”
法晚（微信ID：fzwb_52165216)记者随后联系贝基·巴赫女士。截至3日中午，在收到邮件约12个小时后，她才给予了回复。贝基告诉法晚记者，为了核实斯坦福大学医学院是否与魏则西案件中的涉及的医院有合作关系，他们花了“一些时间”。最终确认，据目前所知，斯坦福大学并未和“魏则西事件”中涉及的医院有任何合作。她同时强调，斯坦福大学医学院并未参与此次事件。
然而法晚记者更多关心的是，这是一种怎样的疗法？是否斯坦福大学仍然在进行这样的临床实验？而这种疗法是否已经美国淘汰？对于这样的问题法晚记者再次追问该医学院，然而这位媒体关系专员的答复令人失望，在今晨给予法晚记者的答复中，她以“我们没有进一步评论”为由拒绝了记者进一步的采访要求。
斯坦福大学医学院目前仍在进行一项CIK研究
魏则西所接受的是DC-CIK细胞免疫治疗，据媒体报道，该方法的治疗原理为将患者体内的两种免疫细胞——树突细胞（DC）和细胞因子诱导的杀伤细胞（CIK）抽取出来，培养、扩增后再回输到患者体内，相当于增加攻打肿瘤细胞的“士兵”，从而增强患者的抗癌能力。
法晚记者在斯坦福大学医学院的临床实验目录下检索，只出现了关于治疗高风险血液肿瘤疾病的移植后自体CIK细胞疗法。而该研究项目于2006年5月开始，与2011年3月正式结束，经历了一期和二期实验。
而法晚（微信ID：fzwb_52165216)记者在美国国家卫生院下属的临床实验网站上查询还发现，于2005年9月12日至最后更新信息的2012年12月间，斯坦福还进行了一项名为“同体造血细胞移植的移植后免疫疗法CIK细胞研究”临床实验，实验为一期临床实验，目前该实验状态为“未知”。
此外，斯坦福大学目前仍有一项关于CIK的临床实验研究在进行中，主要是关于骨髓增生异常综合征(myelodysplastic syndromes）/骨髓增生异常疾病巩固化治疗中进行Post T-PLANT注入自体CIK细胞的治疗。该项目在网站的登记时间为2011年6月21日，预计研究项目完成时间为2018年1月。
法晚记者分别联系这三个CIK细胞疗法项目的主要负责人，但是截止记者发稿时并未收到任何回复。三名主要负责人均来自该学院医学中心的的血液和骨髓移植医学部。
FDA:很多案例中细胞疗法并未达到相关法律规定标准
法晚记者发现，这三项斯坦福大学医学院的CIK细胞疗法研究同时也受到来自美国食品药品监督管理局（FDA)等卫生部门的监管。FDA媒体发言人安德烈·费舍尔告诉法晚记者，美国FDA对用于移植、注入或是转换入体内的人体细胞或组织有一定的监管框架。和人体细胞、组织和以细胞或是组织为基础的产品（简称HCT/Ps)一样，细胞疗法受FDA监管。
费舍尔告诉法晚记者，由于生物的复杂性，很多HCT/Ps需要逐一单独的进行评估，以决定其准确的监管路径。在很多案例中，医学条件下向患者实施的细胞疗法并未符合联邦管理法规的相关规定和标准。这些疗法虽然未被批准上市，但是依然受到政府监管，要求这些产品提供能够说明其安全和有效性的预入市批准。而且在研究者进行临床实验未被批准的药物产品前，需要进行新药临床试验申请。
清华大学博士何霆在接受媒体采访时表示，DC-CIK疗法此前在美国已经历了多年研究，但相关临床试验在美国基本全部宣告失败，没有得到上市许可。目前，在美国确实已经鲜有DC-CIK用于癌症治疗的临床试验，我国是这个技术研究的主力军。
清华大学医学院千人计划教授、著名免疫学专家林欣表示，目前国内没有权威研究认为DC-CIK治疗有明显的效果，国外的临床试验也没有达到预期的治疗效果。至于临床试验结果不好的原因，暂时没有公认的结论。但是在美国，如果没有很好的临床结果，是不能通过权威机构的批准，因此DC-CIK是不能用于临床治疗，只有很少的一些临床研究。
美国国家癌症研究院：治疗癌症的生物疗法依然处于实验性阶段
美国国家癌症研究院（NCI)发言人迈克在接受法晚记者采访时表示，她了解到目前百度搜索引擎结果和对这一疗法的推广在中国引发了广泛关注。但是NCI无法对该事件进行具体的评论。
不过，在他提供给法晚（微信ID：fzwb_52165216)记者关于细胞免疫疗法的相关背景信息中显示，对于很多患癌患者来说，生物疗法可能被用于治疗癌症本身或是用于其他癌症治疗带来的副作用。尽管美国FDA批准了很多形式的生物疗法，但是其他关于癌症患者的生物疗法的信息主要是通过在临床实验中的参与（研究涉及人体实验）来获得，目前依然处于实验性阶段。
而生物疗法的副作用因为治疗类型的不同而不同。通常来说，伴随注射或是注入部位带来的疼痛、肿大、红肿、瘙痒等是最普遍的。而更为严重的副作用主要针对少数几种生物疗法。例如通过免疫反应来对抗癌症的疗法可能会引发一系列流感症状，包括发烧、体寒虚弱、晕眩、反胃呕吐、肌肉或关节疼痛、头疼、偶然性呼吸障碍等。而生物疗法引发的免疫系统反应同样会出现严重甚至致命性的过敏性反应的风险。
美国国家癌症研究院发布的信息还指出，癌症免疫治疗是在长期对免疫系统基础研究投资上的进展，这些研究延续至今。目前的研究还包括为什么免疫治疗在一些患者身上有效而在其他患者中无效，将这一免疫疗法扩大到更多类型的癌症治疗中。（记者 黎史翔）
责任编辑：陈琰 SN225
文章关键词： 魏则西 癌症
我要反馈
保存网页
法制晚报