Madison-made technology to treat diabetic foot ulcers
MADISON, Wis. (AP) — Human tests have begun on a wound-healing skin tissue developed in Madison.
ExpressGraft-C9T1 is being tested on up to six patients with diabetic foot ulcers, the Wisconsin State Journal reported. Each participant will get a single application of the product. They’ll be monitored over a 12-month period to observe the technology’s effectiveness and reaction to skin tissue.
The technology is being developed by Stratatech, which is now owned by the British pharmaceutical company Mallinckrodt. The technology is a genetically engineered, antimicrobial human skin substitute.
The tissue may be able to help patients with chronic wounds that are difficult to heal, said Lynn Allen-Hoffmann, the founder and CEO of Stratatech who is now senior vice president of regenerative medicine at Mallinckrodt.
“Diabetic foot ulcers and resulting complications can be physically debilitating and lead to emotionally devastating problems,” said Thomas Serena, CEO and medical director of SerenaGroup, of Hingham, Massachusetts, and lead investigator on the study, which is being conducted in Pittsburgh.
The study is expected to be completed in May 2019. If successful, the product would need two additional rounds of testing before Mallinckrodt could seek approval from the U.S. Food and Drug Administration.
“If safety and tolerability, as well as efficacy, are established in the developmental process for treatment of subjects with diabetic foot ulcers, Mallinckrodt would hope this developmental product would have potential in the treatment of other wound types,” spokeswoman Rhonda Sciarra said.
Stratatech first developed StrataGraft, another skin substitute that’s undergoing separate human testing. It’s in its third phase of trials for treating severe burns.
Stratatech was founded in 2000 after Allen-Hoffmann’s UW-Madison lab discovered a line of human skin cells that didn’t die and didn’t carry viruses or tumors.
Mallinckrodt purchased the company for $76 million in 2016.
Information from: Wisconsin State Journal, http://www.madison.com/wsj