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Stem Cells Go to War

Massive blood shortages continue to plague military trauma care and the problem is even more complicated by the remote, inaccessible locations of today’s war zones. DARPA wants … needs … a synthetic platform that’s engineered to cultivate blood cells.

In 2008, the Defense Advanced Research Projects Agency (DARPA) , the Pentagon’s  research arm, launched the Blood Pharming program,  with the goal of manufacturing mega doses of universal donor red blood units (O-negative) using a compact, self-contained system. “Pharming” is the process of genetically engineering mass quantities of medically useful substances, like hormones or antibodies.

More troops than ever are surviving their battlefield injuries, overloading the military’s health care system.  Around half of US troop fatalities are caused by blood loss from battlefield injuries. Now, with another 30,000 troops deployed to Afghanistan, the Pentagon is pushing for medical advances that can save more lives during combat. 

When an American soldier is wounded in Iraq or Afghanistan and starts to bleed out, there’s not always time to screen replacement blood for diseases the way you would back in the States. When several soldiers are hit at the same time; a so-called “mass casualty event” — unhurt soldiers will just line up, arms extended, ready to donate their own blood to save their comrades. Most military medical professionals believe that fresher blood is better than stale: It carries more oxygen and, when transfused into patients, speeds recovery.

Troops in the field, however, often get blood that’s weeks old. So DARPA backed researchers are working on a $2 M project to “manufacture … red stuff on the spot” with the key ingredient in this “blood pharming” effort: umbilical-cord stem cells. Because most blood used in military operations is donated on US ground, it’s usually 3 weeks old by the time it hits the front lines. The shelf-life of donated blood is still disputed. The Red Cross tosses RBC units after 42 days, but some medical experts think that fresh blood “expires” after 28 days, and cite increased risk of infection and organ failure once blood is older than two weeks

Arteriocyte, Cleveland, OH biotech firm that received $1.95 M for the project, has sent off an initial shipment of their “pharmed” blood product to the FDA and hopes to pass muster with agency’s safety regulators. Arteriocyte researchers were trying to grow big batches of stem cells when they realized that the growing conditions they used—such as temperature and levels of oxygen and carbon dioxide; caused the stem cells to turn into an early stage of red blood cell. At first they were frustrated because they wanted stem cells. Then they realized that they may have unintentionally found a clever way to produce new blood.

This technology created at Johns Hopkins, thinks pharmed blood would have several advantages over relying on the real stuff. Their basically mimicking bone marrow in a lab environment,”  states CEO Don Brown. “Our model works, but we need to extrapolate our production abilities to make scale. Until now, the military’s strategy has mainly been contained to basically using stale blood and setting-up mobile blood banks in a war zone, but even every troop rolling up their sleeve might not be enough when you’ve got a crisis with dozens or more injuries.

The blood was produced using hematopoietic cells, derived from embryonic cord-blood units. Currently, it takes Arteriocyte scientists 3 days to turn a single umbilical cord unit into 20 units of RBC-packed blood. The average soldier needs 6 units during trauma treatment.

The method can get so much blood from a single cord unit, it also minimizes risks associated with multiple-donation transfusions, which are common when a patient needs several units. But while Arteriocyte think they’ve mastered the formula for pharmed blood, they have a ways to go to make it financially viable. A single unit of pharmed blood currently runs them $5,000. Still, given the price tag of transporting and storing donated blood, DARPA’s betting that a unit of pharmed blood will make financial sense once it costs less than $1,000.

Human trials aren’t likely until 2013, but the Pentagon could invoke “emergency protocol” to snag the blood sooner; Brown predicts military use within 5 years. Incidents like these are covered by an “emergency protocol,” meaning the blood is “not approved by the FDA for the purpose of treating life-threatening injuries” because it hasn’t been screened for all potential pathogens, There have been some 6,000 blood protocol waivers in Iraq and Afghanistan since 2007, according to a June report from the Defense Health Board.

But at least one doctor wants to end the practice. “The untested issue is what the Defense Health Board doesn’t like,” board member David Walker, from University of Texas, said. “We want the soldiers to receive the same care that would be approved by the FDA in the United States.” Anticipating a major backlash (after all, this is inured troops’ lives we’re talking about), Walker emphasized that he believes fresh blood is no better than “Packed Red Blood Cells” shipped from the States and stored near the combat zone. He said some combat surgeons hold an “almost religious belief” that so-called fresh whole blood, or FWB, is better suited to treat the often horrific injuries of battle in Iraq and Afghanistan … “At this point, there is not strong evidence to believe that fresh whole blood gives a better outcome,” Walker said. One thing’s for sure: no one is going to take chances with wounded soldiers’ lives. The controversy is over exactly what entails risk.

DARPA has also awarded $9.9 M to the Texas A&M Institute for Preclinical Studies (OTC:TIPS), to develop treatments that can extend a “golden period” when injured war fighters have the best chance of coming back from massive blood loss. Odds of survival plummet after an hour during combat even with quick evacuation, triage; treatment is often impossible. The institute’s research will be based on previous DARPA funded efforts. (HWM, Wired. Inside Defense and Daily Mail)