进口干细胞治疗卒中的临床试验在北京天坛医院启动

2020-07-07 九芝堂美科 九芝堂美科

2020年7月6日,九芝堂美科与北京天坛医院正式签署临床试验合作协议,标志着中国首个进口干细胞新药临床试验即将启动,适应症为“缺血性卒中”。

2020年7月6日,九芝堂美科与北京天坛医院正式签署临床试验合作协议,标志着中国首个进口干细胞新药临床试验即将启动,适应症为“缺血性卒中”。

该试验为一个评估缺血耐受人骨髓间充质干细胞(it-hMSC)治疗缺血性脑卒中后遗症的Ⅰ/Ⅱa期临床试验,主要研究者为天坛医院常务副院长、国家神经系统疾病临床医学研究中心副主任、国家神经系统疾病医疗质量控制中心主任王拥军教授。

试验中,受试者将接受单次注射it-hMSC,评估it-hMSC对缺血性脑卒中患者的安全性和耐受性。受试人群主要为临床诊断为缺血性脑卒中超过6个月,需要他人协助才能行走,或不能独立完成一般日常生活活动的患者。

 

1 干细胞为脑卒中治疗带来新希望

脑卒中全球致死率排名前2,是我国居民死亡的首要病因缺血性脑卒中具有发病率高、致残率高、死亡率高等特点。最新全球疾病负担研究(Global Burdenof Disease Study,GBD)显示,我国总体卒中终生发病风险为39.9%,位居全球首位,这意味着中国人一生中每5个人约有2个人会罹患卒中。

目前脑卒中的治疗办法主要集中在急性期,一旦超过六个月,康复效果就会明显下降或停止,到了后遗症期,除了物理治疗,几乎没有药物手段可以帮助患者恢复,给患者带来终身痛苦,给家庭和社会带来沉重负担。

作为脑卒中的特殊治疗手段,干细胞显示出良好治疗效果。虽然全球上市的干细胞药物已达16种,但是治疗缺血性脑卒中的干细胞药物还是零。此次干细胞治疗缺血性脑卒中I/IIa期临床试验是在美国顺利完成并取得良好结果的基础上,进一步深入探索 it-hMSC 对缺血性脑卒中的治疗作用,同时揭开中国干细胞治疗脑卒中的新篇章,期望为饱受脑卒中困扰的广大患者带来更多希望。

 

2

缺血耐受人骨髓间充质干细胞

本次临床试验所用缺血耐受人骨髓间充质干细胞(it-hMSC)产品是美国Stemedica生产的骨髓间充质干细胞,是从健康年轻成人捐献者的骨髓中提取的干细胞经体外扩增后制备成干细胞药物。全程在模拟人体真实生理环境——低氧条件下培养,细胞性能优于常氧条件。该干细胞产品增殖能力强,可减少缺氧对组织的损伤,减少细胞凋亡并抑制炎症,另外这种细胞对缺血组织的耐受能力强,可促进缺血性纹状体中的神经前体细胞向神经元分化,可持续招募增殖细胞并改善神经血管重构,治疗缺血性卒中前景广阔。

此前,干细胞产品已有非常好的临床基础。

一)在美国

2018年,该产品在美国完成了使用人骨髓间充质干细胞治疗缺血性卒中的I/IIa期临床试验,结果显示,it-hMSC治疗安全性良好,经it-hMSC治疗的患者在精神状态、抑郁程度、生活自理能力等均取得显著性改善,初步证明了干细胞治疗的有效性。试验结果于2019年9月在国际卒中领域专业期刊《Stroke》发表。

二)在中国

2019年,九芝堂美科使用该产品进行的“人骨髓间充质干细胞治疗急性脑卒中的临床前研究”获得北京市科技重大专项资助。

2020年2月19日,九芝堂美科使用该产品向CDE申报的干细胞新药临床试验申请(即IND)获得默示许可。在美科IND之前,获批的前5项IND使用干细胞均为国产,细胞来源包括脐带、脂肪等,涉及的适应症有膝骨关节炎,糖尿病足溃疡,移植物抗宿主病等。以药物申报的方式,开展干细胞治疗神经系统大适应症的临床试验,在国内尚属首次。

 

 

3

全球干细胞治疗卒中临床试验进展

作为卒中的特殊治疗手段,干细胞显示出来的良好治疗效果,给脑血管领域专家开辟了新的治疗途径。

截止2020年7月,在clinicaltrials.gov网站上注册的干细胞治疗脑卒中(包括缺血性脑卒中和出血性脑卒中)的临床研究项目有89项,其中以临床Ⅰ期和Ⅱ期为主,所应用的细胞类型主要是神经干细胞,脐带间充质干细胞、骨髓间充质干细胞,脂肪干细胞、造血干细胞等。

在国内,研究者主要使用神经干细胞和间充质干细胞对脑卒中患者进行临床治疗研究,取得了一定的进展。

需要注意的是,国内干细胞产品IND启动,只是表明药监局允许药品申报企业在合作医院招募临床志愿者开展临床试验,可以申请入组参与治疗。但同干细胞临床研究备案项目一样,均不得向参与研究的病人收取费用。
中国的干细胞药品化在跌跌撞撞中前行。在我国,实施干细胞管理新政(类“双轨制”)后,已经有8项干细胞药物临床试验获批。在政策逐渐明朗以及产业发展新风向标的指导下,我国干细胞临床转化也必将迎来更大的发展。
干细胞治疗缺血性卒中临床试验,祝一切顺利!

参考资料来源:

[1]国家食品药品监督管理总局药品审评中心 

[2]https://www.clinicaltrials.gov/

[3]九芝堂美科公众号

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    2020-07-10 独孤立克

    干细胞是热点,但是进入临床仍然需要时间和临床疗效验证哦

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1897742, encodeId=2863189e742cf, content=<a href='/topic/show?id=999444102f5' target=_blank style='color:#2F92EE;'>#天坛医院#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44102, encryptionId=999444102f5, topicName=天坛医院)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=9c94141, createdName=liuquanmn, createdTime=Fri Jan 08 09:54:41 CST 2021, time=2021-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1771622, encodeId=df101e716222b, content=<a href='/topic/show?id=0dd8336556e' target=_blank style='color:#2F92EE;'>#北京天坛医院#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=33655, encryptionId=0dd8336556e, topicName=北京天坛医院)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=395f25, createdName=爆笑小医, createdTime=Wed Dec 09 23:54:41 CST 2020, time=2020-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025477, encodeId=0e8f10254e7bd, content=干细胞是热点,但是进入临床仍然需要时间和临床疗效验证哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=独孤立克, createdTime=Fri Jul 10 23:54:41 CST 2020, time=2020-07-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=801719, encodeId=de92801e199e, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKYhHcHnOxN7tdgePXpHPDFkff5eB2y1qicicg0ZspwGRJ8JPQ4td6KIYt0HfNvIX60mOUfjVJY3Clw/132, createdBy=f3052413911, createdName=Justby, createdTime=Wed Jul 08 11:45:24 CST 2020, time=2020-07-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1026667, encodeId=45c1102666e32, content=卒中虽然是临床上常见病,溶栓,取栓等血管内治疗也很成熟,但是仍然有很多未知问题有待认知!, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=健健, createdTime=Wed Jul 08 02:54:41 CST 2020, time=2020-07-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=801674, encodeId=b47e8016e405, content=<a href='/topic/show?id=9bbb48e7692' target=_blank style='color:#2F92EE;'>#干细胞治疗#</a>卒中启动, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48776, encryptionId=9bbb48e7692, topicName=干细胞治疗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Wed Jul 08 00:05:16 CST 2020, time=2020-07-08, status=1, ipAttribution=)]
    2020-07-08 Justby

    学习了

    0

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    2020-07-08 健健

    卒中虽然是临床上常见病,溶栓,取栓等血管内治疗也很成熟,但是仍然有很多未知问题有待认知!

    0

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    2020-07-08 lovetcm

    #干细胞治疗#卒中启动

    0

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