Health Planning Commission: technologies must not be used in clinical treatment of immune cells | | Wei JI Wei of immune cells _ news
Original title: governance solutions | National Guard Planning Commission: immune cell technologies must not be used in clinical treatment of _fin
Beijing News News (reporters Wen Ru Dandan Li) according to the latest national health and family planning Commission said, for treatment of autoimmune cells of concern, according to the "clinical studies" provisions. The Beijing News reporter learned from multiple sources, this means that immune cell therapy techniques may not be used for clinical treatment, previous national health planning Commission has not approved this treatment.
Immune cell technologies "involves significant ethical issues"
"Wei Zexi event" application of immune cell therapy into focus. On May 4, the State family planning Commission was held on regulating departments of medical institutions of health management and medical management teleconference technology. Conference call that is not on the "limiting clinical application in medical technology (2015 version)" in the list of the first catalogue of class III medical technology clinical application allows other technologies (mainly refers to the treatment of autoimmune cells), in accordance with the relevant regulations of clinical research.
The Beijing News reporter learned from multiple sources, in accordance with current regulations and national health planning Commission statement, immune cell therapy is not used in clinical treatment.
Previously, the Ministry of Health announced in 2009 that the clinical management of application for medical technology, medical technology is divided into three categories. Among them, the immune cell therapy technology belongs to the third type of medical technology, need to go through the Ministry of Health's approval before they can carry out.
According to this approach, immune cell therapy, gene therapy and cloning treatment technology technology, by the Ministry of health as "involves significant ethical issues, safety and effectiveness of standard clinical trials are needed to further validate the medical technology".
Last year, the new rules do not let go of immune cell therapy technology
In July last year, according to the decision on the removal of administrative approval items, State Health Planning Commission issued a notice that, cancel approval class III medical technology clinical practice admittance. It is also seen as the technology faces a policy point.
This document refers only to ban cloning in the clinical treatment of medical institution technology, surrogate technologies, such as limb lengthening except for medical purposes, "immune cell therapy" does not appear in it.
Based on this, some sectors of the industry after "immune cell therapy clinical applications of the technology," understanding began to diverge.
There are arguments that immune cell therapy is not included in the restrictions list, that is, the access to clinical areas. Tumor medical experts have also proposed during an interview with the Beijing News, policy has not made clear whether this technology can be used in clinical treatment, presumably belonging to the "grey area".
In this regard, participated in the third category experts in technology management policy clear to Beijing news reporters, the intent of the policy, that is, immune cell therapy cannot be "let go", but in accordance with the relevant regulations of clinical research. "Because the technology, while promising, but in many ways immature. ”
The expert noted that immune therapy against diseases such as melanoma, it works, but not as an independent treatment to apply, can be used as cancer treatments such as surgery, radiotherapy, chemotherapy added. And the best combination of these treatments, specific additional effectiveness, academic is the lack of sufficient evidence.
"Clinical research" consensual and not charging
This national health planning Commission reaffirmed the characterization of immune cell therapy as "clinical research". What are the boundaries and clinical treatment?
According to regulations, medical institutions to carry out clinical research projects require qualification of the laws and regulations identified, drug and medical device clinical trial shall be governed by the corresponding request accreditation, and possess the corresponding ability.
Experts, in accordance with the requirements of the national sanitation Planning Commission, first of all, of medical institutions permits the immune cell therapy research, but need to meet clinical research on medical ethics. The second, based on the principle of informed consent, patient informed consent. Third, the non-profit principle based on clinical studies, medical institutions are not allowed to charge participants.
(Original title: governance solutions | National Guard Planning Commission: technologies must not be used in clinical treatment of immune cells)
Responsible editor: Xiang Changming SN123
Article keywords:Immune cells Health Planning Committee
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卫计委：免疫细胞技术不得用于临床治疗|免疫细胞|卫计委_新闻资讯
原标题：政解|国家卫计委：免疫细胞技术不得用于临床治疗_fin
新京报快讯（记者温薷 李丹丹）按照国家卫生计生委最新表态，对于备受关注的自体免疫细胞治疗技术，按照“临床研究”的相关规定执行。新京报记者从多渠道获悉，这意味着，免疫细胞治疗技术不得用于临床治疗，此前国家卫计委也未批准过这一技术的临床治疗。
免疫细胞技术“涉及重大伦理问题”
“魏则西事件”令免疫细胞治疗技术的应用成为焦点。5月4日，国家卫生计生委召开了关于规范医疗机构科室管理和医疗技术管理工作的电视电话会议。会议称，未在“限制临床应用的医疗技术（2015版）”名单内的《首批允许临床应用的第三类医疗技术目录》其他在列技术（主要指自体免疫细胞治疗技术等），按照临床研究的相关规定执行。
新京报记者从多渠道获悉，按照目前规定和国家卫计委的表态，免疫细胞治疗技术是不得用于临床治疗的。
此前，原卫生部2009年公布《医疗技术临床应用管理办法》，将医疗技术分为三类。其中，免疫细胞治疗技术属于第三类医疗技术，需要经过原卫生部的审定方可开展。
按照该办法，免疫细胞治疗技术和克隆治疗技术、基因治疗技术，都被原卫生部归为“涉及重大伦理问题，安全性、有效性尚需经规范的临床试验研究进一步验证的医疗技术”。
去年新规未放开免疫细胞治疗技术
去年7月，根据国务院《关于取消非行政许可审批事项的决定》，国家卫计委下发通知表示，取消第三类医疗技术临床应用准入审批。这也被视为该项技术面临的一个政策拐点。
这份文件只提及了医疗机构禁止临床应用克隆治疗技术、代孕技术、除医疗目的之外的肢体延长术等，“免疫细胞治疗技术”并未出现在其中。
基于此，之后业内一些人士对于“免疫细胞治疗技术是否可以临床应用”理解上发生了分歧。
有言论认为，免疫细胞治疗未列入限制类清单，即说明可以进入临床范畴。有肿瘤方面的医学专家也在接受新京报记者采访时提出，政策并未明确提出这项技术是否可用于临床治疗，推测属于“灰色地带”。
对此，曾参与第三类技术管理政策调整的专家对新京报记者明确，该政策当时的意图，即是不能将免疫细胞治疗技术“放开”，而是按照临床研究的相关规定执行。“因为这项技术虽然有前景，但很多方面并不成熟。”
该专家指出，免疫治疗技术针对黑色素瘤等病种确实有效，但并没有作为一个独立治疗手段来应用，只可作为手术、放疗、化疗等肿瘤治疗手段的补充。对于和这些治疗手段的最佳结合点、具体补充效果如何，学术上也缺乏足够证据。
“临床研究”须知情同意并不得收费
此次国家卫计委重申将免疫细胞治疗技术定性为“临床研究”。其和临床治疗的界线为何？
按照规定，医疗机构开展临床研究项目需要取得法律法规认定的资质，药物和医疗器械临床试验机构应按相应要求获得资格认定，并具备相应能力。
专家介绍，按照国家卫计委的要求，首先，医疗机构准许开展对免疫细胞治疗技术的研究，但需要符合临床研究的医学伦理。第二，要依据知情同意原则，病人要有知情同意书。第三，基于临床研究的非营利性原则，医疗机构不允许向受试者收取费用。
（原标题：政解|国家卫计委：免疫细胞技术不得用于临床治疗）
责任编辑：向昌明 SN123
文章关键词： 免疫细胞 卫计委
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