FDA clears trial of genetically modified pig kidney in patients with end-stage kidney disease

FDA clears trial of genetically modified pig kidney in patients with end-stage kidney disease
Biotech company eGenesis has received FDA approval for a clinical trial of EGEN-2784, a pig kidney with multiple gene changes, in people with end-stage kidney disease (ESKD). Here are the highlights: 

1.  EGEN-2784 underwent three types of genetic edits: removal of three glycan antigens (to avoid immediate rejection), insertion of seven human transcripts that regulate immune response, inflammation, coagulation, and inactivation of endogenous retroviruses in the pig genome. 
2. The trial will be on patients over 50 years of age, dependent on dialysis, on the transplant waiting list. The main evaluation period is 24 weeks after transplantation. 
3. Previously, operations have been performed under expanded access: one patient (Tim Andrews, 67 years old) has been living without dialysis for more than seven months with this kidney; a second patient (Bill Stewart, 54 years old) also was on dialysis for more than two years and no longer needs it after the transplant. 

It is an important step toward solving the acute shortage of donor organs and a possible new era of xenotransplantation – transplanting organs from animals modified so that the human body can accept them. If the trial proves safe and effective, it could have a significant impact on the lives of many patients.