Extreme Medicine Gets Pentagon Push; Human Trials Rushed
(Wired) Some of the most debilitating war injuries, from lost limbs to mangled muscle tissue to permanent burn scars, could soon benefit from cutting-edge regenerative procedures.
Human clinical trials of the latest in extreme regenrative medicine — including bone-fusing cement and muscle-growing cell scaffolds — are being fast-tracked, thanks to an extra $12 million in funding from the Department of Defense.
Researchers at the University of Pittsburgh are working on some of the most promising Pentagon-backed medical research projects. Just last month, Joint Chiefs of Staff Chairman Admiral Mike Mullen visited the university’s labs to see the science firsthand. And despite the looming threat of a shrinking Pentagon budget, he told them that “10 years doesn’t satisfy any of us,” where clinical trials were concerned.
And that’s exactly what this funding infusion is going to address. Dr. B.J. Costello, the lead researcher behind the university’s bone cement project, told Danger Room that the Pentagon’s contract is meant “to catapult us forward.” Costello’s program was expected to be in human clinical trials in 5-7 years. With the new grant, it’ll be more like 12 months to 2 years.
“We needed more help with the process of FDA approval and associated expenses, which a company would pay for if they were planning to produce and market this science,” he said. “Instead, the Department of Defense is picking up that slack.”
Costello, whose program involves the creation of an injectable compound designed to repair cranio facial bone damage or spur normal bone growth, expects to start trials on 20 patients, most of them veterans, within a year. If those trials go well, they’ll expand to test more people or explore using the cement for different, more serious procedures.
“Right now, we’re looking at mild to moderate injuries,” he said. “But eventually this could treat long bone injuries, or have civilian applications.”
And those applications would be widespread. The bone cement could replace metal plates, repair bone damage from car accidents or assaults, and even regrow entire portions of a human skull.
Costello’s hoping the grant will also help them move forward on manufacturing facilities, where the product can be mass produced in a sterile environment.
The Pentagon grant will also hasten clinical trials for muscle tissue regeneration and a novel method of treating burn injuries. Costello is confident that all three procedures are ready for human use.
“The Department of Defense did their homework, and these projects are the cream of the crop,” he said. “This isn’t pie-in-the-sky research. We’re ready to roll.”
[Photo: Noah Shachtman]