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.
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, Allan Doctor, M.D., 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 Doctor in 2016 with bioengineer and synthetic chemist Dipanjan Pan, Ph.D., 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, Ph.D. of Case Western Reserve University that is under development by Haima Therapeutics and a freeze-dried plasma product made by Telefex.
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.
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.
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.