Becker's Clinical Quality & Infection Control

CLIC_September_October_2023_Final

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8 PATIENT SAFETY & OUTCOMES NYU Langone physicians see success with transplantation of pig kidney in human body By Ashleigh Hollowell T he scramble to find kidneys for transplants or the long waits on a list amid a usable organ shortage could come to an end in the future. e use of gene- edited pig kidneys could vastly increase supply and help meet life-saving demand for patients, Robert Montgomery, MD, PhD, the director of the NYU Langone Transplant Institute explained during an Aug. 16 press conference. In 2021, Dr. Montgomery performed the first genetically modified pig kidney transplant in a human decedent and has continued his research which has led to a fih transplant procedure, performed just this July. So far, one month into the observation of the decedent organ recipient, Dr. Montgomery confirmed that "the one-month kidney biopsies and kidney tests show no evidence of rejection and normal renal function and clearance of toxins," he said during the press conference. "e pig kidney appears to replace all of the important tasks that the human kidney manages." e research team still plans to monitor the decedent for another month, but these preliminary findings have moved this field of research closer to a possible living human clinical trial in the future, they explained. "We think that the pig kidney likely requires less genetic manipulation to be accepted by the human immune system than, for instance, a pig heart," Dr. Montgomery said. "e pigs that were used to produce the kidney used in this study are bred; they're not cloned — which means that the gene edits are stable and consistent between pigs, and there's no variation in the dose of the edits. And because they're bred and not cloned they can be scaled much more easily to provide an unlimited source of kidneys for patients who need them." He noted that the herd of pigs with the single gene edit was approved by the FDA as a source of meat for people who suffer from a rare disorder known as Alpha Gale hypersensitivity, and the pigs are closely surveilled and monitored for pathogens in zoonosis. Alpha Gale is a trait that was lost through evolution in humans over time, but it still exists in animals and if introduced into the human body, the immune system responds to attack it, which is why there has previously been a barrier to transplants of this kind, he explained. But this specific herd of pigs has been edited to remove that trait, which removes one barrier for transplants like this to be rejected by the human body. e pig's thymus, a gland in the throat, was also placed under the covering of the kidney for several months prior to the transplant which "has been shown to help protect the kidney from being attacked by the human immune system," Dr. Montgomery confirmed. Immunosuppressive drugs were also used, but he noted that nothing that was not already FDA approved was used in the study. Next, Dr. Montgomery said more research will need to be done to understand how to manage a living patient recipient of a pig kidney. He hopes these safe, effective results help move research forward to future clinical trials. "We have some work to do in terms of ensuring that we're doing this as safely as we can for living recipients and that we're going to provide good quality of life and life years to anybody who receives a pig kidney and that we have the best information we can as to how to appropriately manage patients aer they receive a pig organ transplant, as opposed to a human transplant," he said. n Maryland system's new partnership to improve outcomes for emergency trauma patients By Ashleigh Hollowell E very passing minute matters for patients in need of emergency blood transfusions and now Maryland's first responders in partnership with the University of Maryland Medical Center in Baltimore will carry whole blood on board for air-lifted patients, according to an Aug. 22 news release. The addition of whole blood on board the state's fleet of emergency air-lift helicopters will allow first-responders to perform blood transfusions in the field to patients who have suffered extreme trauma. Whole blood has not been separated into different components and it "contains all of the factors necessary for optimal clotting and has become the blood product of choice for the resuscitation of patients with extreme bleeding at leading trauma centers across the United States and elsewhere over the last five years," according to the release. "The clock for the Golden Hour starts ticking at the time of injury, not at hospital arrival. If a patient's condition worsens in the field, or they have a cardiac arrest before arriving to us, their survival chances are markedly diminished," Thomas Scalea, MD, the physician-in-chief at R Adams Cowley Shock Trauma Center and the system chief for critical care services for the University of Maryland Medical System. The second helicopter carrying whole blood was deployed in July — two months after the state deployed the first one in May. Prior to this, crews received extensive training on transfusing blood in the field as well as guidelines to inform their decision- making process about which patients may be in most need of such a service. The whole blood units that are not used are given back to UMMC's Blood Bank to ensure nothing goes to waste. n

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