"You don't need a refrigerator to store it, and in a powder form it can be transported to and stockpiled wherever it's needed," said Anirban Sen Gupta, the Wallace R. Persons Professor of Biomedical Engineering at the Case Western Reserve School of Medicine and Case School of Engineering, who led the study. "Platelets currently cannot be taken outside of a hospital. But if you could give platelets closer to the point of injury, you improve the chance of survival."
The advance opens the door to administering synthetic platelets on a battlefield, at a car accident scene, or during a mass casualty event. Sen Gupta also serves as chief technology officer of Haima Therapeutics, a company he co-founded with Case Western Reserve alumna Christa Pawlowski, which is developing and commercializing the synthetic platelet product known as SynthoPlate.
"Developing a freeze-dried formulation is a critical milestone in translating this technology from the lab to real-world use," said Pawlowski, Haima's chief operating officer and executive vice president of research and development. "A shelf-stable, portable product is essential for scalable manufacturing, distribution and stockpiling, and it significantly expands the ability to use the product to save lives both in the hospital and in prehospital settings."
Beyond shelf stability, the research team also successfully tested a novel intraosseous delivery technique in laboratory studies, injecting synthetic platelets directly into the bone marrow. This approach could accelerate treatment in remote areas or disaster zones where establishing a conventional intravenous line is difficult or impossible. Results from this line of investigation were published in the Journal of Thrombosis and Haemostasis.
The synthetic platelets were manufactured, freeze-dried, and tested by Haima, with additional testing conducted by researchers at Case Western Reserve and the University of Pittsburgh School of Medicine. Matthew Neal, Watson Chair and Professor of Surgery at Pitt and chief medical officer at Haima, led the Pittsburgh team.
"On the battlefield or at the scene of a car accident, it can be impossible to secure an IV line to deliver blood through the vein of a severely bleeding victim," Neal said. "That is why it was critical that we ensure this life-saving synthetic platelet technology be effective when delivered directly into bone, one of the most frequent delivery routes used in prehospital resuscitation." Neal also serves as co-director of the Trauma and Transfusion Medicine Research Center at Pitt.
To evaluate the stability and potency of the freeze-dried nanoparticles, the researchers subjected them to extreme temperature conditions and extended storage periods. After rehydration, the synthetic platelets retained their effectiveness across all tested conditions, including two months at 50 degrees Celsius -- a threshold that covers likely storage environments in austere or tropical field settings.
For the intraosseous injection tests, the team focused on delivering the nanoparticles into the shin bone, where the bone sits close to the skin's surface, in a manner conceptually similar to the use of an EpiPen for severe allergic reactions. A medical professional can quickly insert a needle into the bone marrow and administer treatment without first establishing an IV line. Laboratory results confirmed that the nanoparticles rapidly entered the bloodstream, traveled to the injury site, and contributed to hemostasis. The speed of the technique could be decisive in life-threatening bleeding emergencies.
The research received funding from U.S. Department of Defense grants awarded to Sen Gupta, Neal, and Haima. Haima has also received two Small Business Innovation Research grants from the Defense Advanced Research Projects Agency (DARPA) to manufacture and test SynthoPlate in animal models for safety evaluation. The company is targeting a submission to the U.S. Food and Drug Administration to initiate human clinical trials in 2027.
Research Report:Lyophilized Synthetic Platelets: In Vitro Characterization and in Vivo Evaluation in Mouse Thrombocytopenia Model
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