U.S. Disclosure of Gene-Edited Pig Double Kidney Transplant Trial Case The academic community is looking forward to the launch of clinical trials

Financial Associated Press (Shanghai, editor Shi Zhengcheng) news, on January 20, local time, the American Journal of Transplantation published a paper by Alabama State University researchers, disclosing that they successfully completed a pair of gene-edited pig kidney transplantation into a brain-dead patient in September last year.

(Source: American Journal of Transplantation)

This is also the second case of "allogeneic transplantation" of pig kidney that has been disclosed. Just five days before the University of Alabama trial, NYU Langone Medical Center completed the first gene-edited pig kidney transplant trial, transplanting a pig kidney into a brain-dead patient, and the same team conducted the same trial again last December.

In the Alabama State University trial, the transplant was received by a 57-year-old carpenter and motorcyclist who suffered a brain death in an accident while competing in the race. Unlike the New York University experiment, the experiment aims to test whether a pair of pig kidneys transplanted at the same time can successfully function in the human body.

Like the swine heart transplant trial that shocked the world at the beginning of the year, the pig kidneys used in this trial were also provided by biotech company Revivicol. In total, the donor pigs underwent a total of 10 gene edits to avoid rejection by the human immune system, in addition to avoiding the organ growing too large or causing blood clots.

The experiment lasted a total of 78 hours and ended up with the machine struggling to maintain the patient's own function. The experimenters said that there was no acute rejection of the receptor during the trial, and the right kidney began to produce urine within 24 hours after the transplant was completed, but the left kidney produced very little urine.

While the results of several successive trials have attracted a lot of attention, allogeneic transplantation of gene-edited organs remains a scientific, ethical, and practical dilemma.

Taking the swine heart transplant performed by the University of Maryland School of Medicine earlier this month as an example, the leader of the project, Muhammad Mohiuddin, told the media that the FDA clearly informed him that this was a "one-time" trial designed to save an individual's life and could not be considered a clinical trial of allogeneic transplantation. An FDA spokesperson also responded to the media that any request for an allogeneic transplant trial will be evaluated on a case-by-case basis, and researchers should communicate with regulators about the design of the trial "as early as possible and on an ongoing basis."

Multiple research teams are currently communicating with the FDA about clinical trial requests for allogeneic transplantation, but no team has yet been approved. David K.C Cooper, who conducted the research in this direction at Massachusetts General Hospital, told the media that the research in this direction should be turned to clinical trials, and now the scientific community is eager to know: Can pig kidneys be successfully operated in the human body for one year?

In addition to the grim ethical debate, the production capacity of gene-edited pigs is also very limited, and there are supply bottlenecks in the sterile facilities that raise these pigs. To make matters worse, in addition to the organs themselves, some of the drugs that have been shown to be effective in improving survival in the organ trials of baboons receiving pigs also require the FDA to measure whether they are allowed to be used in non-brain-dead patients.