T他第一次进行了基因工程移植的研究, nonhuman kidney to a human body was recently completed at NYU Langone Health—marking a major step forward in potentially utilizing an alternative supply of organs for people facing life-threatening disease.
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被称为异种移植, 手术于周六进行, 9月25日, 2021, 纽约大学兰贡的 Kimmel馆. 罗伯特·蒙哥马利，医学博士，哲学博士, H. 莱昂·帕切特，医学博士，外科教授和 外科学系 纽约大学朗格尼学院的主任 纽约大学朗格尼移植研究所在两个小时的手术中，他领导了一个外科小组. The kidney was obtained from a genetically engineered pig hundreds of miles away and transplanted into a deceased donor. 捐献者靠呼吸机维持生命, 征得家属的同意, for 54 hours while doctors studied the kidney’s function and watched for signs of rejection.
The gene that encodes the glycan known as alpha-gal—which is responsible for a rapid antibody-mediated rejection of porcine organs by humans—was “knocked out” in the donor pig. 另外, 猪的胸腺, 谁负责“教育”免疫系统, was transplanted with the kidney to stave off novel immune responses to the pig kidney.
The surgery was part of a larger study approved by a specially designated research ethics oversight board at NYU Langone. It is the latest step in a research protocol that calls for additional and similar procedures to be performed. Whole body donation after death for the purpose of breakthrough studies represents a new pathway that allows an individual’s altruism to be realized after brain death declaration in circumstances in which their organs or tissues 是 not suitable for transplant.
肾脏被附在大腿的血管上, 在腹部, and covered with a protective shield for observation and kidney tissue sampling over the 54-hour period of study. Urine production and creatinine levels—key indicators of a properly functioning kidney—were normal and equivalent to what is seen from a human 肾移植. Throughout the procedure and subsequent observation period, no signs of rejection were detected. The results of the study will be presented for peer review and subsequent publication.
可用数量, donated organs available for transplant has not grown sufficiently over the past half century, 而对器官的需求却在飙升. According to data compiled by the 器官 Procurement and Transplantation Network of the U.S. 卫生与公众服务部, 有90多个,美国有5万人在等待肾脏移植 ,超过32个,今年到目前为止，已有000人加入了国家肾脏候补名单.
“这是器官移植领域的一个转折性时刻。. 蒙哥马利说. “The medical and scientific communities have been working toward xenotransplantation to sustain human life for more than 50 years. 在这个过程中有许多障碍, 但我们最近的程序极大地推动了这些努力. 这项研究为器官的无限供应提供了新的希望, a potential game-changer for the field of transplantation and those now dying for want of an organ.”
The kidney used in this procedure was procured from a pig in which the alpha-gal biomolecule—principally responsible for the hyperacute rejection of pig-to-human xenografts—has been removed. 这种被称为GalSafe™猪的动物是由Revivicor公司设计的.该公司是联合治疗公司(United Therapeutics Corporation)的子公司. 2020年12月，美国政府宣布.S. Food and Drug Administration approved the GalSafe™ pig for use as a potential source for human therapeutics.
While the research and surgical practices for xenotransplantation have been in development for years at the Transplant Institute, 没有人类捐献者，实际的申请就无法进行. 在等待合适的捐献者几个月之后, 周五下午出现了前进的机会, 9月24日启动了历史性的程序.
他说:“家属希望死者能捐献器官, 但由于减轻的因素, 死者的器官不适合捐献,博士说. 蒙哥马利，他本人就是一颗捐献心脏的接受者. “Instead, the family graciously approved donation of their loved one’s body for this procedure. That extraordinary generosity paved the way for this major step forward in creating a sustainable supply of lifesaving organs and hopefully ending the current paradigm that someone has to die for someone to live.”
LiveOnNY, the nonprofit organization that facilitates organ and tissue donation in the greater New York City 是a, was a critical partner in the effort to obtain consent from the donor family and the prompt retrieval of the porcine organ.
“我赞赏博士. Montgomery and the entire NYU Langone transplant team for this incredible scientific achievement,查德·艾泽尔说, LiveOnNY的首席临床官. “我们正在进入这个领域的一个新时代, and this will give new hope to those on our waitlist as this important research moves forward. It is important to remember that none of this would be possible without the extraordinary donor and their family. We can never thank our families enough for the courage they show in saying yes to donation.”
世界著名的外科医生和研究人员. Montgomery helped pioneer a laparoscopic technique for procuring a kidney for 现场捐赠 这是现在的普遍做法. 他还开发了多米诺骨牌配对肾脏捐赠, 是指两个或两个以上的捐赠者和受者在肾脏置换中配对. This latest milestone in xenotransplantation—albeit part of a longer research process—could signal another exciting chapter in advancing transplantation medicine.
“这里的潜力是不可思议的。. 蒙哥马利说. “如果科学和实验继续积极向前发展, 我们很快就能将异种肾脏移植到活人身上了. 这项工作的未来并不局限于肾脏. Transplanting hearts from a genetically engineered pig may be the next big milestone. This is an extraordinary moment that should be celebrated—not as the end of the road, 但一开始. 要使异种移植成为日常现实，还有更多的工作要做.”