CINCINNATI — If you’ve ever sprained a knee, you know the pain and discomfort it can bring in addition to the time it takes to fully heal. Musculoskeletal injuries are one of the biggest concerns within our nation’s military, costing taxpayers over half a billion dollars a year.
“Muscular skeletal injuries in general are tremendously impactful to military personnel,” said Dr. Brian Grawe, professor at the Department of Orthopedic Surgery at the University of Cincinnati College of Medicine.
Grawe said those injuries add up to time off which in turn impacts mission readiness.
“It’s estimated that 25 million days are lost to active duty a year just on muscular skeletal injuries alone,” he said.
The Journal of Orthopaedic & Sports Physical Therapy research backs up the numbers. Published in 2018, one report said these musculoskeletal injuries account for over 2 million medical visits and nearly $550 million in patient care costs each year.
A leading injury is a tear to the meniscus.
“The meniscus goes between the femur and the tibia,” Grawe said. "The meniscus is ripe for injury. It’s highly functional throughout the entire cycle when we’re walking around moving around so it’s a very common injury to sustain.”
Over several years, Grawe and a team at UC have worked on a solution they hope will improve the recovery and repair of a meniscus tear.
“During surgery, we are going to be stitching the meniscus together as we normally would and then adding that injection in there as well,” Grawe explained.
The team has taken Simvastatin, an already FDA-approved drug used to treat high cholesterol, and redesigned its properties to create a treatment to change how meniscus tears are treated.
The UC biopharmaceutical Amplicore is working on what’s being called AM3101 in conjunction with UC.
“The ultimate goal here is not to just treat the tissue itself but bring back the biomechanical function and for this reason, I think the military was very intrigued by our technology,” said James C. Y. Lin, PhD, Mary S. and Joseph S. Stern Jr. Professor of Orthopaedic Surgery and founder of Amplicore.
The intrigue from the military has turned into a Department of Defense-backed clinical trial to bring the treatment one day to the frontlines.
“This is probably the first of its kind in this category or in the sports medicine category to deal with something injectable to repair even soft tissue,” Lin said.
But their idea is not to just repair the meniscus tissue. The goal is to also reduce the odds of failure.
“Some studies show that over a five-year period, one of every between four or five of those surgeries fail,” Grawe said. “Why that is, because the meniscus tissue has limited blood supply, and as a result of having limited blood supply it has a lower capacity to regenerate and or heal.”
He and Lin both agree their research and study have shown the use of this injection of AM3101 allows the tissue to better fuse together, thus regenerating a better-performing meniscus.
“It will guide the healing so instead of scar formation or just the suture material providing the biomechanical stability your body will see that medicine and allow for that tissue to heal,” Lin said.
UC is the primary location for this research and they’re also working directly with Walter Reed National Medical Center and several other military-affiliated medical facilities. In addition, their team is working with Case Western and Oregon Health Services to have a broad-spectrum-focused dataset to present as they go through the clinical trials.
In all the double-blind study will focus on 74 patients with a mix of civilian and military members. The group will be split with half held in a control group that receives the surgery only, while the other half will receive the Amplicore treatment.
The treatment will be closely monitored with MRI scans to track the healing process.
“We will be able to assess on MRI the characteristics of the meniscus and potentially restored in terms of its healing,” said Grawe. “Because of what the MRI is showing we could potentially say the meniscus is stronger, so we can be more confident in letting the military personnel back into active duty.”
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