Scientists asked US officials to approve clinical trials involving transplantation of organs from pigs into human beings.
The Wall Street Journal reports that multiple universities and research hospitals approached the FDA to request permission for experiments with the transplantation of animal organs into humans. According to sources, these proposals would require strict regulation of clinical trials. The decision will be made on a case by case basis.
The FDA convened a public advisory committee meeting on Wednesday, discussing possible regulatory requirements for interspecies transplantation – also known as xenotransplantation – with transplantologists, according to the outlet.
Baltimore’s University of Maryland Medical Center is one of those institutions which has recently applied for FDA guidance regarding clinical trials or received approval. The University of Maryland Medical Center in Baltimore transplanted a genetically altered pig heart to a critically ill, 57-year old man. David Bennett’s experimental surgery was done under an emergency authorization from the FDA. Doctors discovered a pig virus within his heart after just three weeks. Bennett passed away two months later from causes still under investigation.
The University of Maryland is currently moving ahead with studies on baboons while seeking FDA guidance on additional steps required for human trials, Dr. Muhammad M. Mohiuddin, one of the doctors involved in Bennett’s surgery, told the WSJ.
Researchers at the University of Alabama at Birmingham also plan to seek FDA approval for a clinical trial, said Dr. Jayme Locke of the university’s Heersink School of Medicine’s Comprehensive Transplant Institute. CTI transplanted kidneys from pigs into the bodies of brain-dead people earlier in this year.
New York University’s Langone Transplant Institute is also interested, according to its director Dr. Robert Montgomery. “We are on the path to clinical trials,”He spoke to the WSJ.
While the FDA is reportedly concerned about potential infections of animal organs that could spread not just to recipients but their family members, transplantologists are saying that it’s not possible to guarantee the donated human organs are perfectly healthy, either. They say clinical trials will allow scientists to share and analyze data while providing better oversight for the FDA.
There is no way to know when and if the FDA will approve these trials. To make up the shortage in human donors, transplantologists want to have access to organs from animals. The United Network for Organ Sharing is a federally funded nonprofit which assists in organ distribution. It estimates that more than 6000 Americans will die each year while waiting for an organ donation.
[ad_2]
