Stratatech is moving forward with tests of a genetically engineered human skin that could heal the sores and wounds many diabetic patients get on their feet.
Stratatech said the ExpressGraft skin tissue builds on some of the same technologies the company pioneered in developing StrataGraft, its flagship skin replacement product. StrataGraft is cell-based skin tissue designed to coax the bodies of burn patients into regenerating skin.
The trial Stratatech announced on Wednesday is a Phase 1 study aimed at assessing the safety and efficacy of ExpressGraft in the treatment of diabetic foot ulcers.
More than 30 million people in the U.S. have diabetes, according to the Centers for Disease Control and Prevention. Diabetic foot ulcers are open wounds or sores that are estimated to occur in up to 25 percent of diabetic patients in their lifetime, researchers wrote in a 2005 paper published in the Journal of the American Medical Association. Foot disorders are among the leading causes of people with diabetes needing to be hospitalized, according to a 2006 paper in the Journal of Foot and Ankle Surgery.
Stratatech said it plans to enroll up to six patients in its initial study of ExpressGraft. Each patient must have a Type 1 or Type 2 diabetes diagnosis, as well as a foot ulcer that has persisted for at least four weeks and as long as a year.
All study participants will receive a single application of ExpressGraft skin tissue on a foot ulcer, Stratatech said. The company said it will monitor patients’ vital signs, blood chemistry, and infection rates for 12 months after they are treated with the skin tissue.
If the treatment works, patients’ wounds will begin to heal. Stratatech said ExpressGraft is genetically modified to express elevated levels of cathelicidin, a peptide with antimicrobial properties that can help heal wounds by promoting tissue growth and blood vessel formation.
“Enhancement of antimicrobial action through genetic modification may benefit patients with chronic, difficult-to-heal wounds, such as those seen in patients with diabetes,” said Lynn Allen-Hoffmann, who founded Stratatech in 2000 and is now senior vice president of regenerative medicine at Mallinckrodt, in a prepared statement.
Stratatech said it expects to complete the study by May 2019.
Meanwhile, Stratatech is also conducting Phase 2 and Phase 3 trials of its core skin replacement product, StrataGraft. It’s meant to be an alternative to grafting tissue from another part of a patient’s body onto the wounded area.
Stratatech has been part of Mallinckrodt since 2016, when it was acquired by the U.K. company for $76 million in cash, plus potential future milestone payments.