“The U.S. Food and Drug Administration has given the green light to two biotechnology companies for clinical trials that will transplant organs from genetically modified pigs into people with kidney failure. If successful, these studies could lead to the broader use of cross-species transplantation, a dream of medical scientists for centuries…

The United Therapeutics study, which is expected to begin midyear, will start with six patients who have been on dialysis for at least six months but do not have other serious medical problems. There will be a three-month waiting period between each transplant so that doctors can learn from the outcomes.

If the first six transplants are successful, the trial will expand to include up to 50 participants in what is called a phaseless trial — a type of study that combines the traditional Phase 1, Phase 2 and Phase 3 trials and can lead directly to approval…

The eGenesis trial will begin with three patients with kidney failure who are unlikely to receive a human organ within five years.”

From New York Times.