Funding Will Be Used to Develop Shelf-Stable Product for Trauma
Patients to Potentially Save Lives
BALTIMORE, Feb. 4, 2023
/PRNewswire/ -- A University of Maryland
School of Medicine (UMSOM) physician-scientist will head a
new federally-funded research program to develop and test a whole
blood product, storable at room temperature, that can be used to
transfuse wounded 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 biotech companies.
"We have assembled an outstanding team to develop a
bio-synthetic whole-blood product that can be freeze-dried for easy
portability, storage, and reconstitution," said study principal
investigator Allan Doctor, MD,
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 medics at the point of injury, and
will perform 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 employ sophisticated
artificial intelligence, state-of-the-art experimental platforms,
and multiple complimentary animal models. The product will be
tested for efficacy and safety in trauma victims who have complex
multiple injuries including shock and traumatic brain injury.
Bleeding is the most common cause of potentially survivable
death in trauma, in both military and civilian settings. Whole
blood transfusions remain the gold standard but present logistical
challenges such as the dependence on available donors, requirement
for cold storage, and limited viability of about 40 days. Rapid
evacuation of patients who are rapidly bleeding out 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
with a long shelf life that is easy to transport.
To conduct this project, Dr. Doctor has assembled a consortium
comprising faculty members from UMSOM and UMSOP to work on the
artificial oxygen carrier (red blood cell) component that he
pioneered in earlier studies and on pharmacology, computational
modeling, and machine learning to optimize the combined 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 bioengineer and synthetic chemist Dipanjan Pan, PhD, MSc, Professor in nano
medicine at Penn State University, and
Philip Spinella, MD, a military
transfusion medicine expert at the University
of Pittsburgh.
It will also include a synthetic platelet product developed by
Anirban Sen Gupta, PhD of
Case Western Reserve University that is
under development by Haima Therapeutics and a freeze-dried plasma
product made by Telefex.
Dr. Doctor is a founding partner, Chief Scientific Officer, and
Chair of the Board of Directors for KaloCyte, which could
potentially benefit from this research. His interest in the company
has been reviewed in accordance with the university's conflicts of
interest policy to ensure objectivity in the research.
"We are well-positioned to support this highly complex
project that requires the use of advanced modeling and simulation,
and a machine learning software system to optimize the prototypes
and to test for safety and efficacy in models of complex trauma
with multiple complications," said study co-investigator
Joga Gobburu, PhD, MBA, Professor of
Practice, Sciences, and Health Outcomes Research, and Director of
the Center for Translational Medicine at UMSOP.
The first phase of the study will be to integrate multiple
bio-artificial and synthetic components to deliver oxygen, stop
bleeding, and replace volume; these are key therapeutic functions
of whole blood in resuscitation. In the second phase, the team will
evaluate efficacy and safety in increasingly complex and realistic
trauma models. This phase will also involve developing strategies
for stabilizing the product for months under ambient climate
conditions in extreme environments.
Throughout both phases, the team will also plan, develop, and
refine manufacturing methods. This will address the real-world
pragmatic challenges of production, scaling, packaging, and quality
control that must be surmounted to enable effective transition of
the developed products to successful clinical trials and,
eventually, to safe and efficient clinical utility.
While UMSOM and UMSOP will be leading this effort, the
consortium also includes leading scientists and complimentary
experts from Case Western Reserve
University, Charles River Laboratories, Latham Biopharm
Group, Ohio State University, Pumas-AI
Inc., Southwest Research Institute, University
of California San Diego, University of
Pittsburgh, Oregon Health Sciences
University, University of Texas
Austin and University of North
Carolina, in addition to the companies developing the
bio-synthetic blood components themselves: Haima Therapeutics,
KaloCyte, and Teleflex.
"About 20,000 Americans each year bleed to death before they
can be brought to the hospital. Transfusion at the point of injury
is required to stablilize them and limit other organ injury,"
said UMSOM Dean Mark T. Gladwin, MD, Vice President for Medical
Affairs, University of Maryland,
Baltimore, and the John Z. and Akiko K. Bowers Distinguished
Professor. "This project will utilize cutting edge technologies
like artificial intelligence to predict interactions among the
blood components in various trauma model systems, which would not
have been possible a decade 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 are
not available. Other subcontractors have the potential to join the
consortium pending the exercise of additional options in the FSHARP
award.
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 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 distinguished
two-time winner of the Albert E.
Lasker Award in Medical Research. With an operating budget
of more than $1.3 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 nearly 2 million patients each year. The School of
Medicine has nearly $600 million in
extramural funding, with most of its academic departments highly
ranked among all medical schools in the nation 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 local community. The
School of Medicine, which ranks as the 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 latest U.S. News & World Report
ranking of the Best Medical Schools, published in 2021, the UM
School of Medicine is ranked #9 among the 92 public
medical schools in the U.S., and in the top 15 percent (#27)
of all 192 public and private U.S. 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