干细胞再生医学“耐心等待”产业化

2017-03-29 赵广立 科学网

伤口70年不能愈合是种怎样痛苦的体验?创面数十年难以愈合、长年被严重的溃疡和感染所困扰、丧失最基本的行动能力,这是许多糖尿病足患者的切肤之痛。在中国工程院院士、解放军总医院生命科学院院长付小兵收治的病例中,有一位来自浙江的患者,其因糖尿病足形成的创口已长达70年之久。

伤口70年不能愈合是种怎样痛苦的体验?

创面数十年难以愈合、长年被严重的溃疡和感染所困扰、丧失最基本的行动能力,这是许多糖尿病足患者的切肤之痛。在中国工程院院士、解放军总医院生命科学院院长付小兵收治的病例中,有一位来自浙江的患者,其因糖尿病足形成的创口已长达70年之久。病人最后的日子里,唯一的愿望就是,在死之前穿上袜子。

聊以慰藉的是,这位患者的临终愿望终于实现——在治疗中,付小兵团队使用了干细胞技术等再生医学的手段,预后52天患者的创面基本实现了愈合。

记者从3月18日北京汉氏联合生物技术股份有限公司(下简称“汉氏联合”)举办的干细胞与再生医学技术战略发展论坛上得知,这还只是再生医学诸多成功探索中的一个缩影。

从难愈性疾病说起

“对于与上述案例中类似的慢性难愈合创面,中国每年大概有3000万人左右的治疗需求。”付小兵是我国著名的创伤医学专家,他直言,像这种慢性难愈合创面,过去一直没有很好的解决办法,上世纪90年代以后,他们开始探索一些新的治疗模式和方法,来解决病患的痛苦。

“像糖尿病足,痊愈非常困难:一方面没有专门的科室和大夫负责治疗,另一方面也确实没有行之有效的治疗方法。”付小兵说,在我国,糖尿病足病人出院时只有60%治愈率,这也就意味着40%并没有治愈——没有正规治疗,就会发展成越来越严重的慢性难愈性创面。

加之,由于许多糖尿病患者在早期根本不知道怎样防控糖尿病足,有25%的糖尿病患者不得不面对与文章开头类似的厄运。

“之所以出现几十年没有愈合的创面,根本原因就在于人们对疾病的成因、发病机制、治疗方法等都没有清楚的认识和有效的手段。”因此,付小兵常常思考,能不能用一些新的治疗技术方法来解决这个“老大难”。

而他们的临床探索证明,治疗糖尿病足的一个重要手段,就是用再生医学技术来实现。

“糖尿病足是因下肢血管疾病引起的腿部和足部创面,而利用干细胞可以促进血管的再生长,重新建立起血液循环;再辅以外科治疗手段,就能最终解决糖尿病足的治疗难题。”付小兵说,“这一技术已经在很多临床医院推广应用,可以降低糖尿病足病患者30%~40%的截肢率——这无疑意义巨大。”

此外,干细胞技术还被用以再生汗腺,造福烧伤患者。

“干细胞的诱导分化功能,可以在病患身上实现汗腺再生。这一技术的成功使用,可望建立一种利用干细胞再生汗腺的重大新技术,帮助烧伤病人逃离每天不得不吹空调、泡水缸的命运。”付小兵说。

产业化的“非科学性问题”

Nature曾在2016年一期特刊中这样描述再生医学,称其是“一系列大胆的技术和技术的集合,其目的是恢复我们的生理状态,让其类似于原始的状况”。对此,法国国家技术科学院和法国国家医学科学院两院院士、汉氏联合董事长兼首席科学家韩忠朝介绍说,“我们人体组织、器官会不断磨损——损伤、衰老以及产生的一系列疾病,特别是难治性的疾病,都有可能通过干细胞再生医学的技术得到治疗,再生医学现在已公认是将来除药物、手术之外的第三条医疗途径,干细胞与可再生医学是新兴的和有长足发展的行业。”

付小兵也印证了这一点:“再生医学以及干细胞技术,在中国科学院和工程院都有发展路线图,比如指出了‘到什么时候要实现多少关键技术突破’等。”

然而话锋一转,付小兵说:“关于干细胞与再生医学,基础研究没问题、临床实验也应该没问题,关键是产业化的问题。”他提出,干细胞技术从临床实验到产业化、到临床应用,这个转化的过程可能会有问题——主要是政策法规和管理的问题等。

2016年12月16日,国家食药监总局出台了《细胞制品研究与评价技术指导原则》(征求意见稿)。然而这一指导原则何时能够正式颁布、细胞制品的规范何时出台仍无确定的时间表。

在此次论坛的圆桌讨论阶段,解放军第307医院全军造血干细胞移植中心主任陈虎就将大家普遍关心的“指导原则何时正式出台”这一问题抛给了国家食药监总局中检院研究员冯晓明,但没有得到确切答复。

“食药监局这个指导原则,是以后企业要遵循的、是引领产业发展的出口,如果没有这个,(企业前期探索)就相当于全是白做。”陈虎解释说。

在干细胞药品的研究进展方面,汉氏联合是国内比较领先的。韩忠朝向《中国科学报》记者透露,目前该公司已有3种干细胞制剂完成了临床前试验,下一步将选择7个临床适应症,进行一期、二期、三期的药物开发。此外,汉氏联合还在组织工程技术方面进行了深入探索,由付小兵主持的创伤修复干细胞凝胶即是其中一例,目前该凝胶已完成了临床前研究,进入临床研究阶段。

“更关键的是我们制定了一系列的细胞制品的企业标准,这些标准在国内、欧盟都是符合相关要求的,可以说是国际领先的。”韩忠朝说。

冯晓明在答复中提及了涉及指导原则出台的一些问题:“在干细胞技术推广应用方面,我认为还有很多重要的工作要做,比如标准化的工作、GMP规范的工作、产品质量控制的工作等。我个人也希望企业能够把干细胞技术产品生产应用的一些好经验、一些生产规范贡献出来,为干细胞规范性发展做一些有益工作。”

此外,冯晓明提出,在细胞治疗一些机理研究方面还有不是很清楚的地方,但他同时表示“不清楚不代表不能用”。

投资者要“比科学家有耐心”

不得不承认的一点是,今天,美国干细胞事业正在蓬勃发展。尽管美国FDA对干细胞治疗的方法采取了强硬措施,规定所需的药品和器械需要同样严格的测试程序,但这并没有阻止干细胞临床产业增长。

全国政协常委、副秘书长,九三学社中央常务副主席邵鸿在该论坛致辞中也表示,干细胞和再生医学是生物学和医学领域的新兴领域,在这方面有着激烈竞争。

干细胞再生医学到底有多大的产业前景?

韩忠朝给出了中外两个权威机构的两组数据:国外机构预测到2020年,干细胞再生医学产业将达到675亿美元产值,而中商产业研究院预测到2020年左右,将产生约1500亿人民币的产值。

然而,作为投资界的代表,东方证券股权投资与交易部总监唐洁认为干细胞技术产业作为受制于政策的高新技术领域,有其行业特殊性。投资者对干细胞产业化的期盼要有更多耐心,对干细胞企业的估值要更加理性,因为“罗马不是一天建成的”。

“出于安全需要,干细胞技术需要更多临床数据,科学家不得不经受漫长时间和投入,因此投资人对于这类企业的估值要更加科学,更加符合新兴产业的特质。”唐洁说,这个行业每一个进步、每一个新产品的研发都代表着科学发展和全人类的进步。她奉劝有志于踏足该行业的投资者要和科学家“一起保持耐心,一起坚守信心”。

对此陈虎点评道:“如果投资环境比我们的科学家还有耐心,那是非常好的事情。”

在“建成罗马”的等待中,各方应如何行动?付小兵提出:“我觉得基础科学家、临床医生、企业家、投资家最好能够结合起来,互相支持,这样将来可能对整个以干细胞为代表的再生医学产业化的发展,会起到很好的作用。”

韩忠朝认为,再生医学技术产品涉及细胞产品、组织工程产品和其他相关的生物制品和材料器械,这些产品大多是创新性复合产品,产品的审批入市如走通常的I类新药审评之路太长。应参考日本和韩国的做法,开通绿色通道,产品完成II期临床研究后即可允许有条件的进入临床应用。这样,既能促进这一新兴产业的发展,又坚持了安全第一的审慎态度。

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    2017-04-05 cnxcy
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    2017-03-30 cqykthl

    干细胞应用于临床还需要更多努力

    0

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    2017-03-30 shaosai

    好好学习,涨知识

    0

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    2017-03-30 lyh994

    美好的未来

    0

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    2017-03-30 1e131c8cm23(暂无匿称)

    学习了学习了再学习了!

    0

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    2017-03-30 刘煜

    学习了谢谢分享

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1928069, encodeId=ca2f19280695d, content=<a href='/topic/show?id=115d2439854' target=_blank style='color:#2F92EE;'>#产业化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=24398, encryptionId=115d2439854, topicName=产业化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=827b160, createdName=cnxcy, createdTime=Wed Apr 05 18:24:00 CST 2017, time=2017-04-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=183764, encodeId=f9cc183e64e0, content=干细胞应用于临床还需要更多努力, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NdicLmdJEK9VoiaDianY6fzHNN9iaGv80m39pMHU3eSnNN0kn1o0rdQ7Bz2f03Qibcf1ia7rKvxIt4UVlErF2d4gCmDC5/0, createdBy=98e31740255, createdName=cqykthl, createdTime=Thu Mar 30 10:53:57 CST 2017, time=2017-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=183726, encodeId=2d6a183e2646, content=好好学习,涨知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zSn0GqHrsfLANEL7Sww3HicKsN9aribicAmGGWXOIMEiaZ1iadgZg9RibjqSwIKUS8gSPib2NwTVg2zVvVJhdP3BkuDIl/0, createdBy=944d1605392, createdName=shaosai, createdTime=Thu Mar 30 09:23:39 CST 2017, time=2017-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=183710, encodeId=6798183e1036, content=美好的未来, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/04/24/1c2dbd6706e64df33befd6663f1d6b37.jpg, createdBy=94f61661779, createdName=lyh994, createdTime=Thu Mar 30 08:42:43 CST 2017, time=2017-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=183665, encodeId=ab9c1836656c, content=学习了学习了再学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161006/IMG57F650B19932A3251.jpg, createdBy=fa6e1959577, createdName=1e131c8cm23(暂无匿称), createdTime=Thu Mar 30 06:50:34 CST 2017, time=2017-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=183657, encodeId=dec118365e2a, content=学习了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Thu Mar 30 06:35:08 CST 2017, time=2017-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=183616, encodeId=c29c183616ac, content=很好的学习资料,谢谢了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20161026/IMG58107C0F82E499574.jpg, createdBy=00e81970035, createdName=1e15b6fem30(暂无匿称), createdTime=Wed Mar 29 23:54:16 CST 2017, time=2017-03-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=183589, encodeId=681a18358919, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zSn0GqHrsfLEudJO7WUea4BZ0iamO76bia2tTguja1n4ZQ57rr6RIkMqaTOn102bgBTjFlh26J7cH0hsLBoxyVcB/0, createdBy=b91b1726746, createdName=ideal肿瘤医, createdTime=Wed Mar 29 22:48:43 CST 2017, time=2017-03-29, status=1, ipAttribution=)]
    2017-03-29 1e15b6fem30(暂无匿称)

    很好的学习资料,谢谢了。

    0

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    2017-03-29 ideal肿瘤医

    学习了

    0