The Food and Drug Administration (FDA) of the United States is planning to allow clinical trials to test the transplantation of pig organs into human beings. If the US FDA follows through, the clinical trials can be an important step in an effort to ease the devastating shortage of human donor organs in the world. This planning comes in the wake of some experimental surgeries involving the pig organs transplantation into a critically sick man and the brain-dead patients.
A person familiar with the matter said it is still not clear when the clinical trials will start and added that the proposal from the researchers will be handled case by case. Many research groups have sought guidance from the US FDA on how to start the clinical trials or making plans to seek approval for FDA to launch the trials, including those at the University of Maryland Medical Center in Baltimore and the University of Alabama at Birmingham.
These clinical trials will allow to conduct study of larger number of patients, along with collection of robust data collection and strict monitoring of the safety. In this case, the researchers will likely involve small number of hospitals having experience with pig organ transplantations.
The researchers at the University of Alabama are planning to seek US FDA approval to launch a clinical trial. Earlier this year, the Alabama program has reported that it had transplanted pig kidneys into the body of a brain-dead person, with the organs producing urine before the trial was ended.