Funding will be used to develop shelf-stable product for trauma patients to potentially save lives
BALTIMORE, February 4, 2023 /PRNewswire/ — A University of Maryland School of Medicine (UMSOM) physician-researcher will lead a new federally-funded research program to develop and test a room-temperature storable whole blood product that can be used to transfuse injured soldiers in the field within 30 minutes of injury, potentially saving thousands of lives. UMSOM will manage the $46.4 million four-year research project administered by the Defense Advanced Research Projects Agency (DARPA), in collaboration with the University of Maryland School of Pharmacy (UMSOP) and more than a dozen universities and biotechnology companies.
“We have assembled an exceptional team to develop a biosynthetic whole blood product that can be lyophilized for easy portability, storage and reconstitution,” said principal investigator of the study Allan DoctorMD, Professor of Pediatrics and Director of the Center for Blood Oxygen Transport and Hemostasis (CBOTH) at UMSOM. “It will be designed for easy use in the field by doctors at the point of injury, and will work like a traditional blood transfusion to, for example, stabilize a patient’s blood pressure or facilitate blood clotting.”
To achieve this goal, the program will use sophisticated artificial intelligence, state-of-the-art experimental platforms and multiple complementary animal models. The efficacy and safety of the product will be tested in trauma victims who present with multiple complex injuries, including shock and traumatic brain injury.
Hemorrhage is the most common cause of survivable death from trauma in both military and civilian settings. Whole blood transfusions remain the gold standard but present logistical challenges such as dependence on available donors, cold room requirement, and limited viability of approximately 40 days. Rapid evacuation of patients who are bleeding rapidly due to a gunshot wound or other trauma is not always an option. For this reason, there is an urgent need for an artificial blood product having a long shelf life and easy to transport.
To carry out this project, Dr. Doctor assembled a consortium of UMSOM and UMSOP faculty members to work on the artificial oxygen carrier (red blood cell) component that he pioneered in previous studies and pharmacology, computer modeling and machine learning to optimize the combination product, which will also include synthetic platelets and freeze-dried plasma.
This product will consist of ErythroMer, the artificial blood product made by KaloCyte, a company co-founded by Dr. Doctor in 2016 with a bioengineer and a synthetic chemist. Dipanjan saucepanPhD, MSc, Professor of Nanomedicine at Penn State UniversityAnd Philippe SpinelleMD, military expert in transfusion medicine at University of Pittsburgh.
It will also include a synthetic platelet product developed by Anirban Sen Guptadoctorate from Case Western Reserve University which is being developed by Haima Therapeutics and a lyophilized plasma product manufactured by Telefex.
Dr. Doctor is a founding partner, scientific director and chairman of the board of KaloCyte, who could potentially benefit from this research. His interest in the company was considered in accordance with the university’s conflict of interest policy to ensure the objectivity of the research.
“We are well positioned to support this very complex project which requires the use of advanced modeling and simulation, as well as a machine learning software system to optimize prototypes and test safety and efficiency in complex trauma models with multiple complications,” said study co-investigator Joga GobburuPhD, MBA, Professor of Practice, Science and Health Outcomes Research, and Director of the Center for Translational Medicine at UMSOP.
The first phase of the study will integrate several bio-artificial and synthetic components to deliver oxygen, stop bleeding and replace volume; these are key therapeutic functions of whole blood in intensive care. In the second phase, the team will assess efficacy and safety in increasingly complex and realistic trauma models. This phase will also consist of developing strategies to stabilize the product for months under ambient climatic conditions in extreme environments.
Throughout both phases, the team will also plan, develop and refine manufacturing methods. This will address the pragmatic real-world challenges of production, scale-up, packaging, and quality control that must be overcome to enable efficient transition of developed products into successful clinical trials and , eventually, toward safe and effective clinical utility.
While UMSOM and UMSOP will lead this effort, the consortium also includes leading scientists and complementary experts from Case Western Reserve UniversityCharles River Laboratories, Latham Biopharm Group, Ohio State UniversityPumas-AI Inc., Southwest Research Institute, University of California San Diego, University of Pittsburgh, Oregon Health Sciences University, University of Texas at Austin And University of North Carolinain addition to the companies developing the biosynthetic blood components themselves: Haima Therapeutics, KaloCyte and Teleflex.
“About 20,000 Americans bleed to death every year before they can be taken to the hospital. Transfusion at the point of injury is needed to stabilize them and limit further organ damage,” said UMSOM Dean Mark T. Gladwin, MD, Vice President of Medical Affairs, University of Maryland, Baltimoreand Professor Emeritus John Z. and Akiko K. Bowers. “This project will use advanced technologies such as artificial intelligence to predict blood component interactions in various trauma model systems that would not have been possible ten years ago.”
DARPA’s Fieldable Solutions for Hemorrhage with bio-Artificial Resuscitation Products (FSHARP) program aims to develop a field-deployable, shelf-stable whole blood equivalent that can be used to resuscitate trauma patients when donated blood products do not are not available. Other contractors have the potential to join the consortium pending the exercise of additional options under the FSHARP award.
University of Maryland School of Medicine
Now in its third century, the University of Maryland School of Medicine was established in 1807 as the first public medical school in 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 laureate of the Albert E. Lasker Medical Research Award. With an operating budget of over $1.3 billionthe 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 nationwide in research funding. As one of the 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 School of Medicine and Medical System (“University of Maryland Medicine”) has an annual budget of over $6 billion and an economic impact of nearly $20 billion on the state and the local community. The School of Medicine, which ranks first 8th highest among public medical schools in 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 the 92 public medical schools in the United States and in the richest 15% (#27) out of 192 public and private American medical schools. The School of Medicine works locally, nationally and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu
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SOURCE University of Maryland School of Medicine