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Physicians working in Cleveland Clinic’s new state-of-the-art Organ Recovery Center hope to begin a clinical trial by the end of 2018 that will allow them to evaluate and, if necessary, revive donated livers that currently would be rejected for transplantation.
The trial will involve the use of a normothermic ex vivo machine that was created in house by Cleveland Clinic clinicians and engineers; the device can assess, enhance and preserve human organs under physiologic conditions.
“We’re preparing for the ultimate study where we’re going to hopefully demonstrate that this device can rescue nontransplantable organs,” says Cristiano Quintini, MD, director of the Liver Transplant Program and principal investigator of the clinical trial.
Dr. Quintini will conduct his study in the new recovery center a 1,300-square foot space located in the main hospital operating room area that has five organ preservation bays and eight machines for organ preservation and revitalization.
Shorten the waiting list
The upcoming trial will be the third involving the device. During the first, which was completed last year, Dr. Quintini and colleagues used the device to preserve usable livers — instead of the five-decade old practice of using ice — which were then transplanted into 15 patients. During the second, which is ongoing, they are employing a modified version of the original device, which is now smaller and more portable, and are once again using it to preserve usable livers for transplantation, this time in 10 patients.
During the third trial, Dr. Quintini and his team will use the device to assess and/or enhance organs that currently would be deemed nontransplantable. A transplant surgeon may discard an organ for a variety of reasons. For example, if the organ was deprived of oxygen for too long before transplantation and showed signs of ischemic injury or if it showed signs of damage from certain conditions such as fatty liver disease or even simply because it came from someone who was elderly.
“There are a lot of organs that on paper appear to be very borderline,” Dr. Quintini says. “Physicians tend to be very conservative and reject those organs because if you transplant them in the patients and they don’t work, the patient will die.”
Based on preliminary data obtained using the machine to evaluate livers rejected for transplantation, Dr. Quintini found that 60 to 70 percent of rejected livers could be used in patients if they were evaluated and rejuvenated using his device.
“This would transform the lives of many patients who otherwise might not get a chance to receive a donated liver,” he says. “Right now, 15 to 20 percent of patients die without ever even getting an offer.”
Extends life of the organ outside the body
A liver that is transplanted the traditional way on ice can last only 8 to 10 hours. With a perfusion device such as the one Dr. Quintini and his colleague made, however, physicians can preserve organs better during transportation because the machine maintains body temperature and oxygenation and can supply nutrients and medication to revive the organ while in transit.
Dr. Quintini and colleagues recently published a study showing that their machine can keep a liver functional for up to 86 hours outside of the body.
“It’s about a 10-fold increase in the amount of time that you can keep an organ viable outside of the body,” he says. “Very few things in medicine provide us with a 10-fold increase of the baseline. This is very revolutionary technology. I imagine in the future we will only be turning down organs that are really, really non-transplantable.”