TUESDAY, Feb. 4, 2025 -- The U.S. Food and Drug Administration (FDA) has approved the first-ever clinical trials testing pig kidney transplants in people with kidney failure, marking a major step forward in cross-species transplantation.

2025年2月4日，星期二——美国食品和药物管理局（FDA）批准了有史以来首次对肾衰竭患者进行猪肾移植的临床试验，标志着跨物种移植迈出了重要一步。

Two biotechnology companies,

两家生物技术公司，

United Therapeutics Corporation

联合治疗公司

and

和

eGenesis

eGenesis

, have been cleared to begin their studies this year.

，已获准今年开始学习。

If successful, these trials could revolutionize organ transplantation, helping address the severe shortage of donor kidneys.

如果成功，这些试验可能会彻底改变器官移植，有助于解决供体肾脏的严重短缺问题。

“We are entering a transformative era in organ transplantation,”

“我们正在进入器官移植的变革时代。”

Mike Curtis

迈克·柯蒂斯

, president and chief executive of eGenesis, told

，eGenesis总裁兼首席执行官

The New York Times

《纽约时报》

.

.

United Therapeutics Corporation will start its study with six patients. All have been on dialysis for at least six months and have no other serious medical problems. The trial will eventually expand to 50 participants if the first transplants go well. eGenesis will begin with three patients, increasing in stages..

联合治疗公司（United Therapeutics Corporation）将开始对六名患者进行研究。所有患者都接受了至少六个月的透析治疗，没有其他严重的医疗问题。如果第一次移植进展顺利，试验最终将扩大到50名参与者。。。

Doctors will monitor each transplant patient for 24 weeks and require lifelong follow-ups to track health outcomes and potential risks such as pathogens that could cross from pigs to humans, according to

据报道，医生将对每位移植患者进行24周的监测，并要求终身随访，以跟踪健康结果和潜在风险，例如可能从猪传播到人类的病原体

The Times.

《泰晤士报》。

More than 550,000 Americans have kidney failure, and nearly 100,000 people are on the transplant waiting list. Yet fewer than 25,000 kidney transplants were performed in 2023, and many patients wait years or die before receiving a donor organ, according to

超过55万美国人患有肾衰竭，近10万人在移植等待名单上。然而，据报道，2023年进行的肾脏移植不到25000例，许多患者在接受供体器官之前要等待数年或死亡

The Times.

《泰晤士报》。

Genetically engineered pigs offer a promising solution because their organs are similar in size and function to human kidneys.

基因工程猪提供了一个有前途的解决方案，因为它们的器官在大小和功能上与人类肾脏相似。

Both of the companies have modified pig genes to reduce the risk of organ rejection and improve compatibility with human bodies.

两家公司都对猪的基因进行了修饰，以降低器官排斥的风险，并改善与人体的相容性。

United Therapeutics pigs have undergone 10 gene edits, adding six human genes and removing four porcine genes linked to rejection.

联合治疗猪已经进行了10次基因编辑，添加了6个人类基因，删除了4个与排斥反应相关的猪基因。

eGenesis pigs have undergone 69 gene edits, most to inactivate viruses that could pose a risk to humans.

eGenesis猪经历了69次基因编辑，大多数是为了灭活可能对人类构成风险的病毒。

While the potential benefits of cross-species transplantation are groundbreaking, concerns about safety and ethics persist.

虽然跨物种移植的潜在好处是开创性的，但对安全和道德的担忧仍然存在。

Some experts worry about known pathogens jumping from pigs to humans, though both companies raise their pigs in pathogen-free facilities that adhere to strict biosecurity protocols and regularly screen the animals for pathogens,

，

The Times

《泰晤士报》

reported.

已报告。

Christopher Bobier

克里斯托弗 Bobier

, an associate professor specializing in bioethics and health policy at Central Michigan University College of Medicine, told

中密歇根大学医学院生物伦理与健康政策副教授告诉

The Times

《泰晤士报》

that in a worst-case scenario, the recipient of an animal’s organ “could become infected with an undetected pathogen from the porcine source.”

在最坏的情况下，动物器官的接受者“可能会感染来自猪源的未检测到的病原体”

Others question whether patients can truly give consent, considering how difficult it is for people on dialysis to refuse a potential life-saving solution.

考虑到透析患者拒绝潜在的挽救生命的解决方案有多困难，其他人质疑患者是否能够真正同意。

“Saying no would be incredibly difficult,” Bobier said. “Fully grasping the lifelong implications of that decision would be even harder.”

“说不太难，”博比尔说。“完全理解这一决定的终身意义将更加困难。”

United Therapeutics expects to begin transplants by mid-2025, with a few months between procedures to assess each outcome before moving forward.

联合治疗公司（United Therapeutics）预计将在2025年年中开始移植，手术间隔几个月，在取得进展之前评估每个结果。

eGenesis plans to wait six months between its first two patients, then three months before transplanting a third.

eGenesis计划在前两名患者之间等待六个月，然后三个月再移植第三名患者。

Even if these trials prove successful, the cost of pig organ transplants and whether insurance will cover them remain unclear, according to

据报道，即使这些试验证明是成功的，猪器官移植的费用以及保险是否涵盖这些费用仍不清楚

The Times

《泰晤士报》

.

.

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