DARPA puts $46.4M toward synthetic blood development

Twelve universities and labs are participating in the effort to try to make a synthetic product to treat blood loss in people

By Hanna Webster
Pittsburgh Post-Gazette

PITTSBURGH — Researchers at the University of Pittsburgh are part of a multimillion-dollar, federally funded program looking to solve a problem that has long-plagued scientists and surgeons: how to manufacture whole synthetic blood to treat blood loss in human patients.

The Defense Advanced Research Project Agency, which is part of the Department of Defense, announced Tuesday that it will grant a total of $46.4 million to a number of organizations, including Pitt, to validate synthetic blood for human blood transfusions. The project is led by the University of Maryland, Baltimore, and consists of 12 universities and labs in total.

Severe blood loss results in 30,000 preventable deaths each year, said Dr. Philip Spinella, one of three lead Pitt faculty members on the DARPA project.
Severe blood loss results in 30,000 preventable deaths each year, said Dr. Philip Spinella, one of three lead Pitt faculty members on the DARPA project. "Nine 9/11 events a year is what's occurring," he said. (Photo/Getty Images)

Severe blood loss results in 30,000 preventable deaths each year, said Dr. Philip Spinella, one of three lead Pitt faculty members on the DARPA project.

Research by Dr. Spinella, professor of surgery and critical care medicine at the University of Pittsburgh School of Medicine, co-director of the Trauma and Transfusion Medicine Center and associate medical director of the Center for Military Medicine Research at Pitt, has shown that blood loss due to trauma is the leading cause of death in both military personnel and civilians ages 1 to 46.

"Nine 9/11 events a year is what's occurring," Dr. Spinella said in regard to deaths from blood loss.

Scientists have tried for years without real success to make synthetic blood, and the technology has never been tested in humans. But Pitt researchers think that creating the individual components of blood and then combining them will get researchers closer to their goal.

The funding will last four years, after which time researchers expect to have a proposal they hope will lead to FDA approval to test the synthetic blood in humans. They anticipate testing the synthetic blood in human patients in six to eight years.

"When blood donations decline — as we have seen during the COVID pandemic — that threatens availability everywhere, even in high resource settings," Cmdr. Jean-Paul Chretien, DARPA program manager and Navy medical officer, said in a news release about the project. "Blood availability also could be at risk in military engagements with large numbers of casualties, with a sudden and significant increase in need."

There's a shortage of viable blood for people who need blood transfusions, not just for trauma patients. Last year, the American Red Cross announced a blood shortage amid the Omicron surge that led to delayed critical care for patients. In a Wednesday news release, the Red Cross said the winter season often drives blood donations down and urged civilians to donate, particularly O-blood-type donors.

"There are hospitals I can see from my window in Oakland that have blood shortages," said Dr. Matthew Neal, associate professor of surgery at Pitt's School of Medicine and a UPMC trauma surgeon. "For patients who are bleeding, access to this resource is severely limited."

The Post-Gazette recently reported on a pilot program that would allow ambulances around the city to carry whole blood.

KaloCyte Inc., co-founded by Pitt's Dr. Philip Spinella, has developed an artificial red blood cell.( Kalocyte Inc.)

Two main barriers to stocking blood banks are typing and storage, issues synthetic blood would eliminate. To make synthetic whole blood, researchers are working on formulating the individual components — red blood cells, plasma and platelets — and then combining them back into a dried powder form. This will allow for longer-term storage over years (versus days for human blood). Synthetic blood would not require typing and therefore allows for treatment of more patients.

Each component of the dried blood could be combined in different proportions to treat various bleeding conditions, from postpartum hemorrhage to blood loss from a gunshot wound.

And when scientists make synthetic blood, they intend to remove the proteins that cause the body's immune system to reject it: The product will be "immune silent," said Dr. Spinella.

Synthetic blood first needs to be validated in an animal model and examined under a microscope in a lab setting. Dr. Susan Shea, assistant professor of surgery and bioengineering at Pitt, will be in charge of this task in her microfluidics lab examining blood flow, which part of the funding will cover.

"A big role is to make sure the clotting function works," she said. " UPMC and Pitt have a unique and strong collaboration between the clinical side and the bioengineering department, which is a particular strength."

Drs. Neal and Spinella run the Trauma and Transfusion Medicine Center at Pitt, a decades-long leader in transfusion care in the U.S.

"This is literally what we live and breathe," said Dr. Neal.

For its role in the project, Pitt will act as a centralized blood bank supporting other lab centers involved with their supply of the components, as well as continue conducting its own research on creating the synthetic blood product.

Dr. Spinella is the co-founder of biotech startup KaloCyte Inc., which also received DARPA funding. He said KaloCyte has developed an artificial red blood cell that can be dried for synthetic blood. Dried plasma, which helps to stop bleeding and maintain the health of blood, was used on World War II battlefields, and dried platelets are in the process of being validated, something Dr. Neal has been working on for the past seven years.

"How you put them together is kind of the trick," said Dr. Spinella. "That's what this project will help us with."

Biotech company Haima Therapeutics, in Cleveland, Ohio, is also receiving funding; Dr. Neal is on its scientific advisory board.

Dr. Matt Kutcher, an associate professor of surgery and emergency medicine at the University of Mississippi Medical Center, a trauma surgeon and an ICU doctor, said dried synthetic blood that is shelf stable will make a big difference to people living in rural areas. The University of Mississippi Medical Center is the only level 1 trauma center and children's hospital in the state.

"If someone gets in a car accident or gets shot and is one-and-a-half hours away from the nearest medical centers, all our knowledge about what works doesn't matter," he said. "It's not that we don't know what to do, it's that we don't have the logistics to get to everyone who needs help as quickly as possible."

A dried synthetic blood product, he said, could be carried by a medic in a backpack or stored on ambulances. "The availability of an artificial substance that you can keep on a shelf really, really matters — especially in rural America," said Dr. Kutcher.

He also said that Drs. Shea, Neal and Spinella, as well as Dr. Anirban Sen Gupta of Case Western Reserve University, who developed a synthetic platelet product, were "super geniuses" and "known thought-leaders in the field."

Dr. Kutcher also runs a National Institutes of Health-funded lab studying clotting abnormalities of blood.

"These experts are highly sought after," he said. "Anything they have to say, we listen."

While clinical trials can take many years, Dr. Kutcher said that because work has already begun on making the individual components of the product, the technology could make its way into human trials quicker.

"That's why it's so important to have a big government agency coordinating and optimizing trials," he said. "I'm really excited that they're putting their heads together."

Dr. Neal called the project a challenge of implementation. "It really has to be seamless," he said. "This funding prioritizes high-risk, high-reward science. Only through a program of this size with the backing of DARPA can a product like this come to fruition."

"We are laser-focused on the science of resuscitating bleeding patients and making sure no one dies from bleeding," said Dr. Neal.


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