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美国FDA批准转基因猪,推进医疗用途的异种移植

2020-12-16 生物探索 生物探索

这是 FDA批准的首个可以同时用于人类食物消费和作为潜在疗法来源的IGA动物。

近日,美国FDA宣布,批准了United Therapeutics公司旗下Revivicor公司的一种有意改变基因组(intentional genomic alteration,IGA)的家猪——GalSafe猪上市。

这种家猪改变旨在消除猪细胞表面表达的α-半乳糖。新闻稿指出,这是 FDA批准的首个可以同时用于人类食物消费和作为潜在疗法来源的IGA动物。

据悉,α-半乳糖是在异种器官移植中,导致急性免疫排斥的主要原因,仅存在于哺乳动物体内,但不包括人类。而一部分人在食用含有“α-半乳糖”的肉类后,会引发过敏。因此,GalSafe猪不仅可以为过敏者提供安全食用的肉类,同时还可以用于为过敏者生产药物,包括不含α-半乳糖的血液稀释药物肝素。

不仅如此,科学家也正在研究将猪器官移植在人类身上,而“GalSafe猪”的组织和器官将可能潜在地解决接受异种移植患者的免疫排斥问题。另外,“GalSafe”猪的饲养条件要比传统猪饲养条件严格很多,而且没有发现“GalSafe”猪本身的安全问题。

当然,FDA也表示,任何机构或研究所在将“GalSafe”猪用于新药、移植或人体植入之前,都必须寻求FDA的进一步批准。FDA局长表示,首次批准一种动物生物技术产品用于食品和潜在的生物医学用途,代表着科学创新的巨大里程碑。

使用猪的器官来缓解移植器官的短缺是多家生物技术公司开发的方向。例如,美国科学院和工程院双院士,哈佛大学(Harvard University)George Church教授和合成生物学家杨璐菡博士共同创立的eGenesis公司,以及中南大学湘雅三医院的王维教授等与湖南赛诺生物科技公司组成的联合团队,都在开发适合作为人类移植器官供体的转基因猪。

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    2021-03-28 bugit
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    2020-12-18 muzishouyi

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