“With these severe injuries it’s been drilled into us through all of our training that functional muscle replacement is not possible,” said principal investigator Stephen Badylak, D.V.M., Ph.D., M.D.
, professor of surgery at Pitt and deputy director of the McGowan Institute for Regenerative Medicine
. “The sort of technology we’re developing offers hope where there otherwise would have been no hope.”
Badylak envisions creating a device that would change the environment inside larger wounds to help them heal the way smaller wounds do naturally.
All of that would be accomplished by a smart device implanted inside the wound.
The device will monitor key molecular signals at each stage of healing — from the first hours after injury to the days and weeks that follow — and deliver specific molecules at specific times under the direction of artificial intelligence.
The first two years of the project will involve developing the device, then the next two years will involve close collaboration with surgeons at Walter Reed, who treat patients with major muscle loss, to refine the design so that it’s suitable for the clinic.
Meanwhile, the researchers will be working with industry partners and the U.S. Food & Drug Administration
to identify and clear regulatory hurdles that might slow down clinical translation. For instance, it’s possible to test whether the components of the device are safe to use in the human body while the overall design is evolving.
“We’re developing the science and the device in mostly an academic setting,” Badylak said. “If that’s done without consideration of regulatory and industry requirements, patients would never see it because it would remain buried in institutions with no clear path for clinical translation.”
One of the companies engaging in this process is ECM Therapeutics
, which Badylak spun out of Pitt in 2018 to speed up the clinical translation of several extracellular matrix technologies developed by his lab. Badylak and Pitt both have a financial stake in the company.
Additional investigators on the grant include Yoram Vodovotz, Ph.D., Ruben Zamora, Ph.D., Douglas Weber, Ph.D., Bryan Brown, Ph.D., Paul Cohen, Ph.D., and Milos Hauskrecht, Ph.D., of Pitt; Tzahi Cohen-Karni, Ph.D., and Adam Feinberg, Ph.D., of Carnegie Mellon University; Jonathan Rivnay, Ph.D., of Northwestern University; Jacob Robinson, Ph.D., Ashok Veeraraghavan, Ph.D., and Omid Veiseh, Ph.D., of Rice University; Gary An, M.D., and Robert Chase Cockrell, Ph.D., of the University of Vermont; Peng Jiang, Ph.D., of the University of Wisconsin; and Eric Elster, M.D., and Seth Schobel, Ph.D., of Walter Reed.
ILLUSTRATION INFO: (click image for high-res version)
CAPTION: "Smart" Wound-Healing Device: The device will go onto injured muscle to deliver and measure molecules in real time, under the guidance of artificial intelligence.