BALTIMORE, March 3, 2022—The University of Maryland School of Medicine Institute of Human Virologya Global Virus Network (GVN) Center of excellence, physician researchers played a collaborative role in the successful transplant last month of a genetically modified pig heart into a patient with end-stage heart disease by creating strategies for monitoring pathogens and developing an infection prevention strategy for this important, unprecedented medical advance.
“Complications from infectious diseases are always a concern in the field of organ transplantation, whether they are infections related to the recipient or the donor, which in this case remarkably happens to be a pig,” said Kapil Saharia, MD, MPH, Assistant Professor of Medicine at the Institute of Human Virology at the University of Maryland School of Medicine and Chief of the Solid Organ Transplant Infectious Diseases Service at the University of Maryland Medical Center. “We are excited to work synergistically on this one-of-a-kind transplant by innovating in laboratory tests and protocols that enable monitoring of potential infections derived from pig donors. »
To reduce the risk of infection, the donor pig was raised in a disease-free laboratory environment and screened for many known porcine pathogens before being brought to the laboratory. Although all pigs are known to have the endogenous porcine retrovirus, researchers had not detected any transmission to humans or non-human primates in previous studies.
Procedures that transfer tissues or organs from one type of animal to another are known as xenotransplantations. The Cardiac Xenotransplantation Program of UMSOM, led by Bartley Griffith, MD, Thomas E. and Alice Marie Hales Emeritus Professor of Transplant Surgery at UMSOM, and Muhammad M. Mohiuddin, MDProfessor of Surgery at UMSOM, has tapped into the world renowned Institute to preemptively minimize any possible risk of potential infection.
“The quality of support from IHV for our experimental surgery has been of great help to us,” said Dr. Griffith. “Our preoperative preparation and postoperative pathogen monitoring has been a significant pathway to discovery and treatment.”
Dr Mohuiddin said: “Although the evidence is lacking, there is real concern about porcine pathogens causing disease in humans. We will continue to follow the patient carefully with the help of the IHV for zoonotic diseases.
Robert C. Gallo, MD, Homer & Martha Gudelsky Emeritus Professor of Medicine and Co-Founder and Director of the Institute of Human Virology at UMSOM, and Co-Founder and International Scientific Director of the GVN said: “Nearly four years ago, the xenotransplantation group came to see us at the Institute of Human Virology for our expertise, in particular related to human retroviruses which are not unlike that of pigs. Dr. Gallo is world famous for his discovery of the first human retroviruses.
Using what other researchers have published on the porcine retrovirus, researchers at the Institute of Human Virology have developed an in-house PCR test that will be used to screen the organ recipient for the virus. The test will be used to monitor the exposure of healthcare workers to this retrovirus over the coming months. The test will also be used for research animal studies needed to advance this procedure to possible clinical trials. These infectious disease doctors will also monitor the patient for any signs of another opportunistic infection due to taking immunosuppressants.
As a prerequisite for emergency clearance from the FDA, the team developed a hospital infection prevention plan for the University of Maryland Medical Center. The doctors who designed the program included Dr. Saharia, Anthony Harris, MD, MPH, professor of epidemiology and public health and division chief of health care outcomes research at the University of Maryland School of Medicine; Surbhi Leekha, MBBS, MPH, associate professor of epidemiology and public health at the University of Maryland School of Medicine and medical director of infection control and hospital epidemiology at the University of Maryland Medical Center; and Michelle Harris Williams, director of infection prevention at the University of Maryland Medical Center.
“Given that this xenotransplantation was performed as part of life-saving surgery, it was difficult to develop workflows to minimize risk to our healthcare providers and hospital staff, as well as other patients. “, said Dr. Saharia. “We have no precedent for xenotransplantation in a clinical setting, so we worked closely with our own infection control epidemiologists to develop a plan that was safe for everyone involved.”
The infection prevention plan used disposable equipment where possible and rigorous disinfection protocols. Additionally, healthcare facilities are instructed to use enhanced contact precautions when caring for the patient, which includes wearing gloves, gowns, and proper hand hygiene, as well as face masks and eye protection due to the ongoing COVID-19 pandemic. To further reduce risk, patient specimens are hand-delivered to the laboratory and handled in the same manner as other highly infectious agents.
“We are happy to be part of a team led by Drs. Mohiuddin and Griffith over the past few years. This is certainly a milestone in the history of organ transplantation,” said Shyam Kottilil, MBBS, PhD, Professor of Medicine, Director of the Division of Infectious Diseases in the Department of Medicine and Director of the Division of Clinical Care and Research at the Institute of Human Virology at the University of Maryland School of Medicine and Senior Scientific Advisor to the GVN. “We will continue to work hand-in-hand with the team to ensure safety and improve clinical outcomes for this patient and others in the future.”
Anthony Amoroso, MD, The Professor of Medicine, Associate Chief of Infectious Diseases and Head of Clinical Care Programs at the University of Maryland Medical School Institute of Human Virology, said, “It’s very exciting that we can work in collaboration to support a pioneering achievement. of Drs. Griffith and Muhammad bringing xenotransplantation into the clinical arena.
Dr. Gallo added, “I would like to congratulate my colleagues in the Department of Surgery, its manager, Dr. Christine Lau, and the other people who contributed to the success of this transplant. Also, in particular, I congratulate the team of our Institute of Drs. Saharia, Kottilil and Amoroso and their colleagues, for their unwavering commitment to supporting this important program and their continued contribution to this unprecedented infectious disease control and detection program, especially in the face of a challenging immunocompromised clinical environment.
About the Institute of Human Virology
Formed in 1996 as a partnership between the State of Maryland, the City of Baltimore, the University System of Maryland, and the University of Maryland Medical System, IHV is an institute of the College of Medicine in the University of Maryland and is home to some of the most recognized and globally recognized experts in all of virology. IHV combines the disciplines of basic research, epidemiology and clinical research in a concerted effort to accelerate the discovery of diagnostics and therapies for a wide variety of chronic and life-threatening viral and immune disorders, including HIV, the virus that causes AIDS. For more information, visit ihv.org and follow us on Twitter @IHVmaryland.
About University of Maryland Medical School
Now in its third century, the University of Maryland Medical School was incorporated in 1807 as the first public medical school in the United States. It continues today to be one of the world’s fastest growing leading biomedical research enterprises – with 46 academic departments, centers, institutes and programs, and a faculty of more than 3,000 physicians, scientists and allied health professionals, including members. of the National Academy of Medicine and the National Academy of Sciences, and a two-time distinguished recipient of the Albert E. Lasker Award in Medical Research. With an operating budget of over $1.2 billion, the School of Medicine works closely with the University of Maryland Medical Center and Medical System to provide intensive research, academic, and clinical care to nearly 2 million patients each year. The School of Medicine has nearly $600 million in extramural funding, with most of its academic departments ranking highly among all medical schools in the nation for research funding. As one of seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 students, trainees, residents and fellows. The combined medical school and medical system (“University of Maryland Medicine”) has an annual budget of more than $6 billion and an economic impact of nearly $20 billion on the state and local community. The School of Medicine, which ranks 8th among public medical schools in terms of research productivity (according to the Association of American Medical Colleges profile) is an innovator in translational medicine, with 606 active patents and 52 start-up companies. In the last US News and World Report ranking of best medical schools, released in 2021, UM School of Medicine is ranked #9 among 92 public medical schools in the United States and among the top 15% (#27) of 192 public and private medical schools in the United States. The School of Medicine works locally, nationally and globally, with research and treatment facilities in 36 countries around the world. To visit medschool.umaryland.edu
Conflict of Interest Statement
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