Fifty years ago, University of Michigan www.michigan.edu Surgeon Robert Bartlett helped invent a life-saving procedure called “Extracorporeal Membrane Oxygenation (ECMO). Today, more than 60,000 patients at 350 medical centers worldwide have been treated with ECMO. Now researchers want to use the next generation of ECMO to keep human lungs viable when undergoing transplantation.
To accomplish this goal, surgeons in U-M’s Extracorporeal Life Support (ECLS) Research Laboratory www.med.umich.edu/ecmo are working on how to evaluate lungs for potential transplantation outside the body during a process called ex vivo lung perfusion.
Advances in ECLS technology have been able to develop organ banking or organ conditioning. The objective is to keep human organs healthy outside the body for several days which is much longer than the current limit of a few hours.
The researchers are preparing for a clinical trial at the University of Michigan Health System called the “Novel Lung Trial”. This trial scheduled will be sponsored by XVIVO www.xvivoperfusion.com, a Swedish-based manufacturer of a machine called the XVIVO Perfusion System (XPS) and also manufacturers the perfusion solution called STEEN Solution. Both the machine and the STEEN will be used in the trial.
During surgery, the surgeon removes the lungs and attaches the lungs to the machine. At that point, the XPS flushes the lungs with STEEN Solution which warms them to normal body temperature, inflates the lungs to their normal size, and then tests them to determine if the lungs are healthy enough to transplant. The machine’s sole function is to enable physicians to evaluate if a lung is viable for transplant.
Advanced ECLS technology is already being used clinically in Canada and Europe either as a temporary bridge to lung transplant or to evaluate the health of lungs awaiting transplant. Researchers are also developing technology to support other organs like hearts, livers, and kidneys outside of the body but this work is still in the animal research stage.
When the trial has been completed, FDA will compare the outcomes of patients who received a conventional lung transplant to outcomes of patients who received lungs where doctors used the XVIVO system. The study’s results will determine whether less than perfect human donor lungs can be approved for transplant in the U.S as they are currently in Canada and Europe.