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April 26, 2019

Contact:

Bill Seiler:

bseiler@umm.edu

410-328-8919

410-328-8919

New Technology Could Expand Donor Access to Transplantation

BALTIMORE, MD, April 26 -- In a first-ever advance in human medicine and transplantation, an unmanned aircraft has delivered a donor kidney to surgeons for successful transplantation in a patient with kidney failure. Transplant physicians and researchers at the University of Maryland School of Medicine (UMSOM) and the University of Maryland Medical Center (UMMC) in Baltimore joined aviation and engineering experts at the Unmanned Aircraft Systems (UAS) Test Site, part of the A. James Clark School of Engineering at the University of Maryland, College Park to complete this landmark, 2.8 mile, 9.52 minute flight on April 19, 2019.

The research was also done in collaboration with The Living Legacy Foundation of Maryland (The LLF), a non-profit organ procurement organization.

"As a result of the outstanding collaboration among surgeons, the Federal Aviation Administration (FAA), engineers, organ procurement specialists, pilots, nurses and, ultimately, the patient, we were able to make a pioneering breakthrough in transplantation," said Joseph Scalea, MD, Assistant Professor of Surgery at UMSOM, who is the project leader and one of the surgeons who performed the transplant at UMMC. Prior to this transplant, Dr. Scalea's team was the first ever to test the drone system by transporting saline, blood tubes and other materials between the launch site and the hospital helipad. Dr. Scalea also noted that the flight took place in an urban environment, over a densely-populated area. "This was a complex process. We were successful because of the dedication of all of the people involved over a long period of time," he said.

This transport system may speed up organ delivery times, expand access to more organs, enhance safety and ultimately improve patient outcomes.

The patient, Trina Glispy, 44, of Baltimore, was discharged from UMMC on Wednesday after a successful transplant procedure. "This whole thing is amazing. Years ago, this was not something that you would think about," said Ms. Glispy, who has been on dialysis since 2011.

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"This major advance in human medicine and transplantation exemplifies two key components of our mission: innovation and collaboration," said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "Innovation is at the heart of our focus on accelerating the pace and scope of discovery, where research can rapidly transform medicine. At the same time, collaboration is the key to our success in providing discovery-based medicine – both in conducting research and in delivering the highest quality patient care."

"For more than 25 years, the University of Maryland Medical Center has provided cutting-edge care in organ transplantation," said Mohan Suntha, MD, MBA, The Marlene & Stewart Greenebaum Professor in Radiation Oncology and President and CEO of the University of Maryland Medical Center. "Our transplant program cares for patients who come from our local community, the state and the nation, many of whom have been turned away at other hospitals, because we have the skill, talent and knowledge to advance even the most complex transplant cases, often times not just improving but saving lives."

According to 2018 data from the United Network for Organ Sharing (UNOS), which manages the organ transplant system in the United States:

  • Nearly 114,000 people were on waiting lists for an organ transplant
  • 36,500 transplants were performed
  • Nearly 30,000 organs came from deceased donors

Challenges in the Current Organ Delivery System

Transportation logistics are often the most complicated part of the organ transplant process, typically involving expensive chartered flights, or relying on the variability of commercial flight schedules, and occasionally resulting in an organ left on a plane, or delays that destroy the organ's viability, according to Dr. Scalea.

"There remains a woeful disparity between the number of recipients on the organ transplant waiting list and the total number of transplantable organs. This new technology has the potential to help widen the donor organ pool and access to transplantation," Dr. Scalea said. "Delivering an organ from a donor to a patient is a sacred duty with many moving parts. It is critical that we find ways of doing this better."

The researchers theorized that unmanned aircraft technology could help solve some of the transport issues by potentially eliminating many of the human hand-offs and reducing the chance of mishaps.

"When we started this project, I quickly realized there were a number of unmet needs in organ transport," said Dr. Scalea. "For example, there is currently no way to track an organ's location and health while in transit. Even in the modern era, human organs are unmonitored during flight. I found this to be unacceptable. Real-time organ monitoring is mission-critical to this experience," he added.

The project also required building a custom unmanned aircraft specifically designed to transport an organ. The aircraft, which was built by UAS test site engineers, needed to meet the rigid medical, technical and regulatory demands of carrying an unaccompanied deceased donor organ for human transplant.

Organ Tracking and UAS Design

For organ tracking, Dr. Scalea partnered with several medical technology companies to develop the Human Organ Monitoring and Quality Assurance Apparatus for Long-Distance Travel (HOMAL; patent pending). The HOMAL, designed expressly for this project, measures temperature, barometric pressure, altitude, vibration and location via global positioning system during transportation. These are all important parameters for an Unmanned Aircraft Systems (UAS) flight that would not have the benefit of a manned aircraft's pressurized cabin. The parameters from this device are then sent directly to the smart phone of transplant personnel in order to better understand the organ's location and status.

"UAS had to address multiple challenges," said Matthew Scassero, MPA, Director of the UAS Test Site and Co-Principal Investigator of the research. "For example, we had to create something that was still within the regulatory structure of the Federal Aviation Administration (FAA), but can carry more weight, for a longer distance. The aircraft also had to be designed with more endurance while it carried the cameras, organ tracking, communications and safety systems. There is a tremendous amount of pressure knowing there is a person waiting for an organ, but it is also a special privilege for us to be a part of that critical link,"; he added.

The aircraft prototype used for this test has several safeguards. Anthony Pucciarella, MBA, Director of Operations at the UAS Test Site, said it is fitted with backup propellers, backup motors, dual batteries, a backup power distribution board and, if the entire aircraft fails, a parachute recovery system. "We always say 'we want to do no harm.' So, we have built a number of redundancies, because we want to do everything possible to protect the payload," said Mr. Pucciarella.

In another precaution taken during this test flight, the Baltimore Police Department blocked ground traffic briefly along the flight path, while the aircraft flew overhead. The aircraft followed an automated course at a height of 400 feet. Pilots were in radio contact with each other and maintained a visual line of sight throughout the entire 9.52-minute flight.

Beating the Clock

Beating the organ transplant clock is a key responsibility of organ procurement organizations throughout the U.S., including The Living Legacy Foundation of Maryland. "We are very time sensitive. We need to be able to work with helicopter services, charter flight services and ground transportation to make sure to get our teams to a donor case and make the gifted organ available to a recipient," said Charlie Alexander, Chief Executive Officer of The LLF.

"The University of Maryland organ transport project is incredibly important," Mr. Alexander added, noting the work is at the proof-of-concept stage. "If we can prove that this works, then we can look at much greater distances of unmanned organ transport. This would minimize the need for multiple pilots and flight time and address safety issues we have in our field."

The researchers agreed that amid all the challenges of organ transplantation, improving the logistics of delivering organs is a critical area where experts can speed up innovation.

Maryland faculty and researchers believe this prototype organ transport blazes a trail for the use of unmanned aircraft systems (UAS) to expand access to donated organs, improving outcomes for more people in need of organ transplants.

"As a result of the outstanding collaboration among surgeons, the Federal Aviation Administration (FAA), engineers, organ procurement specialists, pilots, nurses and, ultimately, the patient, we were able to make a pioneering breakthrough in transplantation," said Dr. Scalea, who was one of the surgeons who performed the transplant at UMMC.

Among the many technological firsts of this effort include: a specially designed, high-tech apparatus for maintaining and monitoring a viable human organ; a custom-built UAS with eight rotors and multiple powertrains to ensure consistently reliable performance, even in the case of a possible component failure; the use of a wireless mesh network to control the UAS, monitor aircraft status, and provide communications for the ground crew at multiple locations; and aircraft operating systems that combined best practices from both UAS and organ transport standards.

Prior to this landmark organ delivery flight, the Maryland partners worked together to develop and test the UAS by first successfully transporting saline, blood tubes, and other materials, and then by transporting a healthy, but nonviable, human kidney. These test flights were preceded in 2017 by the state of Maryland's first civil unmanned aerial delivery of simulated medical cargo, a collaborative effort between UMD's UAS Test Site and the University of Maryland Shore Regional Health in Easton, Maryland, to illustrate how the use of UAS could radically change medical care and impact the lives of real people.

"This history-making flight not only represents a breakthrough from a technological point of view, but provides an exemplary demonstration of how engineering expertise and ingenuity ultimately serve human needs – in this case, the need to improve the reliability and efficiency of organ delivery to hospitals conducting transplant surgery," said Darryll J. Pines, Ph.D., Dean of the A. James Clark School of Engineering and the Nariman Farvardin Professor of Aerospace Engineering. "As astonishing as this breakthrough is from a purely engineering point of view, there's a larger purpose at stake. It's ultimately not about the technology; it's about enhancing human life."

DISCLOSURE:
Dr. Scalea is founder of a private data analytics company, Transplant Logistics and Informatics. Funding for this research was provided by the Maryland Technology Development Corporation (TEDCO) with additional resources from the UAS Test Site, UMSOM, UMMC, the University of Maryland, Baltimore, Office of Technology Transfer, and the City of Baltimore.

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About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 43 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 distinguished recipient of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically-based care for more than 1.2 million patients each year. The School of Medicine faculty, which ranks as the 8th highest among public medical schools in research productivity, is an innovator in translational medicine, with 600 active patents and 24 start-up companies. The School works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit www.medschool.umaryland.edu

About the University of Maryland Medical Center

The University of Maryland Medical Center (UMMC) is comprised of two hospitals in Baltimore: an 800-bed teaching hospital – the flagship institution of the 14-hospital University of Maryland Medical System (UMMS) – and a 200-bed community teaching hospital, UMMC Midtown Campus. UMMC is a national and regional referral center for trauma, cancer care, neurosciences, cardiac care, diabetes and endocrinology, women's and children's health, and has one of the largest solid organ transplant programs in the country. All physicians on staff at the flagship hospital are faculty physicians of the University of Maryland School of Medicine. At UMMC Midtown Campus, faculty physicians work alongside community physicians to provide patients with the highest quality care. UMMC Midtown Campus was founded in 1881 and is located one mile away from the University Campus hospital. For more information, visit www.umm.edu.

About the University of Maryland UAS Test Site

The Unmanned Aircraft Systems Test Site at the University of Maryland stands at the forefront of UAS rulemaking, commercialization, and national airspace integration. Formed in 2014, test site experts leverage their approximately 150 years of combined experience in military and civilian aviation, engineering, and project management to accelerate the safe, responsible application of UAS in public and private industries. The test site is one of only a handful of institutions across the country that work directly with the Federal Aviation Administration (FAA) to advance UAS research and demonstrate operational capabilities, with the ultimate objective of seamlessly integrating UAS into national airspace. This collaboration, along with our expertise in operational procedures, empowers the Test Site to shape rules and industry standards related to UAS technology. The University of Maryland UAS Test Site is a leading research and operations facility led by experts in military and civilian aviation, engineering, and project management. Test site experts leverage decades of experience and cutting-edge technology to accelerate the safe, responsible application of UAS in public and private industries. It is part of the A. James Clark School of Engineering at the University of Maryland.

About The Living Legacy Foundation of Maryland

The Living Legacy Foundation of Maryland (The LLF) is a non-profit organization who saves and enhances lives through organ, eye, and tissue donation and transplantation. We are federally designated to serve the state of Maryland with the exception of Charles, Montgomery, and Prince George's counties. The LLF offer family support, provide education to the public, and are passionate about our mission of saving and enhancing lives.

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