In 2024, eGenesis became the first company to complete a pig liver implant procedure on a live patient. Image credit: 3dMediSphere via Shutterstock

2024年，eGenesis成为首家在活体患者身上完成猪肝植入手术的公司。图片来源：3dMediSphere 通过 Shutterstock

eGenesis has gained US Food and Drug Administration (FDA) clearance on an investigational new drug (IND) application for a genetically engineered porcine (pig) liver.

eGenesis公司已经获得了美国食品药品监督管理局（FDA）对其基因工程猪肝研究性新药（IND）申请的批准。

The organ is designed for use with OrganOx’s extracorporeal liver cross-circulation (ELC) system for patients with acute-on-chronic liver failure (ACLF).

该器官设计用于与OrganOx的体外肝脏交叉循环（ELC）系统配合使用，针对慢性肝衰竭急性加重（ACLF）患者。

The biotech and medtech companies entered an exclusive clinical co-development agreement last year to advance their respective technologies in combination.

去年，这家生物技术和医疗技术公司达成了独家临床合作开发协议，以推进他们各自技术的结合。

Research indicates that around 35,000 patients in the US are hospitalised for ACLF each year. Meanwhile, most individuals wait between three and five years for a kidney, as

研究表明，美国每年约有35,000名患者因ACLF住院。同时，大多数人等待肾脏移植的时间为三到五年，因为

per the American Kidney Fund.

根据美国肾脏基金会。

eGenesis’ pig liver is intended to draw down on the mortality rates in patients awaiting a transplant.

eGenesis的猪肝旨在降低等待移植患者的死亡率。

The Phase I trial plans to enrol 20 patients with ACLF (Grade 2 to Grade 3) and hepatic encephalopathy (≤ Grade 3), who are ineligible for transplant, across multiple US centres.

第一阶段试验计划在美国多个中心招募20名不符合移植条件的ACLF（2级至3级）和肝性脑病（≤3级）患者。

eGenesis’ EGEN-5784 pig liver in combination with OrganOx’s ELC is intended to support the function of patients’ decompensated liver, potentially allowing for the recovery of a patient’s native liver or providing sufficient time to receive a liver transplant.

eGenesis的EGEN-5784猪肝与OrganOx的ELC结合，旨在支持患者失代偿性肝功能，可能允许患者自身肝脏的恢复，或为接受肝移植争取足够时间。

eGenesis CEO Michael Curtis commented: “The FDA’s clearance of EGEN-5784 in combination with the OrganOx ELC system represents a significant advance towards fulfilling our mission to develop safe and effective human-compatible organs that have the potential to transform the treatment of organ failure and extend patients’ lives..

eGenesis首席执行官迈克尔·柯蒂斯评论道：“FDA批准EGEN-5784与OrganOx ELC系统联合使用，标志着我们在开发安全有效、与人类兼容的器官方面迈出了重要的一步，这些器官有潜力改变器官衰竭的治疗方式，并延长患者的生命。”

Last year, OrganOx and eGenesis

去年，OrganOx 和 eGenesis

completed their first extracorporeal perfusion

完成了他们的第一次体外灌注

of a research donor using their combined offerings. The process involved circulating a recently deceased donor’s blood through the genetically engineered EGEN-5784 pig liver outside of their body, with the donor being the first to be enrolled in the companies’ ongoing PERFUSE-2 study.

利用他们综合提供的研究捐赠者。这个过程涉及在捐赠者体外将最近去世的捐赠者的血液循环通过基因工程改造的EGEN-5784猪肝，该捐赠者是公司正在进行的PERFUSE-2研究中的首位参与者。

In the first procedure, stable blood flow, pressure, and pH were maintained throughout the procedure, with no evidence of rejection observed, with the perfusion electively stopped, per-protocol, at 72 hours, with the liver appearing healthy.

在第一次手术过程中，整个手术过程中保持了稳定的血流、压力和 pH 值，没有观察到排斥的迹象，并且按照方案规定，在 72 小时时选择性停止灌注，肝脏看起来健康。

Last year, eGenesis became

去年，eGenesis公司成为了

the first company

第一家公司的

to successfully implant a pig kidney into a living patient at Massachusetts General Hospital (MGH) under the FDA’s expanded access programme and

在FDA的扩大使用计划下，成功地将猪肾移植到麻省总医院（MGH）的一名活体患者体内，并

concluded a $191m Series D financing round

完成了1.91亿美元的D轮融资

to continue the development of EGEN-5784.

继续开发EGEN-5784。

While Rick Slayman, the end-stage kidney disease patient who received the implant, died two months later, MGH stated there was no indication that the death was a result of the transplant.

虽然接受植入物的晚期肾病患者里克·斯莱曼 (Rick Slayman) 两个月后去世，但麻省总医院表示，没有迹象表明死亡是移植手术导致的。