PORCINE HEART TRANSPLANTATION TO ADULT HUMAN WITH END STAGE HEART DISEASE!
The patient accepted a pig heart transplant, which was his only option for survival. In the first of its kind surgery, 57-year-old David Bennett successfully transplanted a genetically modified (GM) pig heart. The patient was found to be in good condition 3 days after the operation. The historic operation was performed at the University of Maryland School of Medicine (UMSOM) in the USA.
This transplant showed that a genetically modified animal heart can function like a human heart without being rejected by the body.
The day before the surgery, patient David Bennett told himself, “Die or get this transplant. I want to live. I know this is shooting a bullet into the dark. But this is my last choice,” he said, and accepted the heart from the pig.
The U.S. Food and Drug Administration (FDA) has granted emergency clearance for surgery on New Year's Eve through its expanded access provision. An experimental medicinal product, in this case genetically modified pig heart, is used when the only option available for a patient facing a serious or life-threatening medical condition. The FDA granted permission to proceed in hopes of saving the patient's life.
Bartley P. Griffith, who performed the organ transplant, stated that this surgery was groundbreaking and brought us one step closer to solving the organ shortage crisis. We do not have enough donor human hearts to meet the needs of potential patients awaiting organ transplant. Bartley stated that they are proceeding cautiously and that they are optimistic that this surgery, which is a first in the world, will offer an important new option for patients in the future.
Mohammed M. Mohiuddin, MD, Professor of Surgery at UMSOM, recognized as one of the world's leading experts in the transplantation of animal organs known as Xenotransplantation, joined the UMSOM faculty five years ago and Dr. He co-founded the Cardiac Xenotransplantation Program with Griffith.
The FDA used our experimental pig data to authorize transplantation in a patient with end-stage heart disease who had no other treatment options. The successful procedure provided valuable information to help the medical community improve it. Dr. Mohiuddin said it could potentially be used as a life-saving method in future patients.
According to the federal government's organdonor.gov site, approximately 110,000 Americans are currently awaiting an organ transplant, and more than 6,000 patients die each year without receiving a transplant. The xenotransplantation method could potentially save thousands of lives, but it carries a unique set of risks, including the possibility of triggering a dangerous immune response. These reactions can trigger sudden rejection of the organ with a potentially fatal outcome for the patient.
Xenotransplants were first tried in the 1980s. But it was largely abandoned after the famous case of Stephanie Fae Beauclair (known as Baby Fae) at Loma Linda University in California. Born with a fatal heart condition, the baby received a baboon heart transplant and died within a month because his immune system was rejecting the foreign heart. However, for many years porcine heart valves have been used successfully to replace valves in humans.
Before patient Mr. Bennett agreed to receive the transplant, he was fully informed of the risks of the procedure and was informed that the procedure was experimental with unknown risks and benefits. He had been hospitalized more than six weeks ago with a life-threatening arrhythmia and had been hooked up to a heart-lung bypass machine called extracorporeal membrane oxygenation (ECMO) for survival. In addition to not being on the transplant list, he was not considered suitable for an artificial heart pump due to his arrhythmia.
The morning of the transplant surgery, Dr. Griffith and Dr. The surgical team led by Mohiuddin removed the pig's heart and placed it in the XVIVO Heart Box, a perfusion device that protects the heart until surgery.
The scientists also used a new drug along with anti-rejection drugs designed to suppress the immune system and prevent the body from rejecting the foreign organ. The new drug used is an experimental compound made by Kiniksa Pharmaceuticals.
Organs from genetically modified pigs have been the focus of most xenotransplantation research, partly because of the physiological similarities between pigs, human, and non-human primates. UMSOM has received a $15.7 million sponsored research grant to evaluate the Revivicor genetically engineered pig UHearts™ in baboon studies.
Three genes responsible for rapid antibody-mediated rejection of pig organs by humans were "knocked out" in the donor pig. Six human genes responsible for immune acceptance of the pig heart have been inserted into the genome. Finally, an additional gene was knocked out in pig to prevent pig heart tissue overgrowth, resulting in a total of 10 unique gene rearrangements in the donor pig.
Dr. Mohiuddin, Dr. Griffith and his research team have spent the last five years perfecting the surgical technique for transplanting pig hearts into non-human primates. Dr. Mohiuddin's xenotransplant research experience spans over 30 years, during which time he has shown in peer-reviewed research that genetically modified pig hearts can function for as long as three years when inserted into the abdomen. Success relied on the right combination of anti-rejection drugs, including experimental donor pig UHeart™ and some experimental compounds.
Daniel G Maluf, Director of UMSOM's Transplantation Program, added: "This is a breakthrough in transplant and medicine." “This study, by Dr. Griffith and Dr. The eventual success of years of research and testing by our multidisciplinary team led by Mohiuddin represents the beginning of a new era in the field of transplant medicine. I am proud of the incredible success of our team. ”
Comments
Post a Comment