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3D生物打印取得里程碑式进展:FDA授予AuriNovo孤儿药物认定用于小耳畸形患者的耳部重建

2019-11-21 Allan MedSci原创

3DBio Therapeutics是人类治疗用3D生物打印领域的新兴领导者,近日宣布,FDA授予AuriNovo孤儿药物认定,这是一种用于小耳畸形患者的耳部重建的研究性组合产品。

3DBio Therapeutics是人类治疗用3D生物打印领域的新兴领导者,近日宣布,FDA授予AuriNovo孤儿药物认定,这是一种用于小耳畸形患者的耳部重建的研究性组合产品。小耳畸形是一种罕见的先天性疾病,导致外耳(耳廓)比正常耳朵小,且畸形,有时在出生时就消失了。大多数情况下只影响一只耳朵。AuriNovo™将患者自身的耳软骨细胞整合到3D生物打印机中,产生全尺寸的耳朵结构,然后将AuriNovo™植入患者头部耳廓区域。

3DBio Therapeutics首席执行官丹尼尔·科恩(Daniel Cohen)博士说:我们很高兴AuriNovo™获得孤儿药认定,这一里程碑强化了我们将AuriNovo™引入市场的承诺


原始出处:

https://www.firstwordpharma.com/node/1682491

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23 02:09:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1362311, encodeId=6242136231118, content=<a href='/topic/show?id=9857e03444b' target=_blank style='color:#2F92EE;'>#畸形#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70344, encryptionId=9857e03444b, topicName=畸形)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca20190, createdName=wushaoling, createdTime=Sat Nov 23 02:09:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1615968, encodeId=f2a21615968f7, content=<a href='/topic/show?id=519345433ea' target=_blank style='color:#2F92EE;'>#孤儿药物认定#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45433, encryptionId=519345433ea, topicName=孤儿药物认定)], attachment=null, 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time=2019-11-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=375637, encodeId=6c6f3e56373e, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/08/03/0e492dda8bcc1f98474b74c2863aca87.jpg, createdBy=068d2446376, createdName=Dr Z, createdTime=Fri Nov 22 07:07:55 CST 2019, time=2019-11-22, status=1, ipAttribution=)]
    2020-01-27 xzw113
  5. 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  6. 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23 02:09:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1362311, encodeId=6242136231118, content=<a href='/topic/show?id=9857e03444b' target=_blank style='color:#2F92EE;'>#畸形#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70344, encryptionId=9857e03444b, topicName=畸形)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca20190, createdName=wushaoling, createdTime=Sat Nov 23 02:09:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1615968, encodeId=f2a21615968f7, content=<a href='/topic/show?id=519345433ea' target=_blank style='color:#2F92EE;'>#孤儿药物认定#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45433, encryptionId=519345433ea, topicName=孤儿药物认定)], attachment=null, 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time=2019-11-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=375637, encodeId=6c6f3e56373e, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/08/03/0e492dda8bcc1f98474b74c2863aca87.jpg, createdBy=068d2446376, createdName=Dr Z, createdTime=Fri Nov 22 07:07:55 CST 2019, time=2019-11-22, status=1, ipAttribution=)]
    2019-11-23 wushaoling
  7. 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  8. 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time=2019-11-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=375637, encodeId=6c6f3e56373e, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/08/03/0e492dda8bcc1f98474b74c2863aca87.jpg, createdBy=068d2446376, createdName=Dr Z, createdTime=Fri Nov 22 07:07:55 CST 2019, time=2019-11-22, status=1, ipAttribution=)]
    2019-11-22 lovetcm

    当年上海交大曹谊林教授在老鼠背上长出人耳朵,原理相似,可惜后来似乎没有往药方面发展

    0

  9. 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    2019-11-22 thm112988

    0

  10. 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time=2019-11-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=375637, encodeId=6c6f3e56373e, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/08/03/0e492dda8bcc1f98474b74c2863aca87.jpg, createdBy=068d2446376, createdName=Dr Z, createdTime=Fri Nov 22 07:07:55 CST 2019, time=2019-11-22, status=1, ipAttribution=)]
    2019-11-22 Dr Z

    学习了

    0

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2019年8月,欧洲耳科与神经耳科学会(EAONO)发布了小耳畸形,耳道闭锁以及功能性耳再造国家共识,文章的主要目的是针对小耳畸形,耳道闭锁患者的功能性耳再造提供指导建议。

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耳缺损是一种先天性和(或)继发性的耳郭畸形。其中,先天性耳郭缺失即先天性小耳畸形是整形外科常见病、多发病,在颅面部先天性畸形中,发病率仅次于唇腭裂。继发性耳郭缺失多为外伤所致,常见的原因包括咬伤、车祸、烧烫伤等。由于耳郭位于头面部,因此,耳郭缺损会对患者的容貌和心理产生巨大的负面影响。耳郭重建是目前治疗耳郭缺失的唯一途径,同时一直也是整形修复的难点。主要原因:首先,人类耳郭具有复杂的三维立体结

IJPO:HRCT与3DVR CT可良好描述先天性耳道闭锁合并小耳畸形

         最近一项运用高分辨率CT(HRCT)和三维容积显像(VR)CT探究先天性耳道闭锁合并小耳畸形患者解剖学差异的研究指出,此类患者的面神经,听骨链,鼓室和卵圆窗均有明显异常。利用HRCT和3D VR CT则能很好的显示这些差异,具有重要的临床价值。      &n

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