A second wound-healing skin tissue developed in Madison has begun tests on human patients.
ExpressGraft-C9T1 is being used in first-round tests on a patient with diabetic foot ulcers — open sores that can affect patients with diabetes and can lead to amputation, said Mallinckrodt, the global pharmaceutical company whose Madison division, formerly Stratatech Corp., developed the tissue.
“Diabetic foot ulcers and resulting complications can be physically debilitating and lead to emotionally devastating problems in this population,” said Thomas Serena, CEO and medical director of SerenaGroup, of Hingham, Massachusetts, and lead investigator on the study, which is being conducted in Pittsburgh.
ExpressGraft-C9T1 is a genetically engineered, antimicrobial human skin substitute. It may benefit patients with “chronic, difficult-to-heal wounds such as those seen in patients with diabetes,” said Lynn Allen-Hoffmann, who was the founder and CEO of Stratatech and now is senior vice president of regenerative medicine at Mallinckrodt.
The phase 1 study is expected to enroll up to six patients who have been diagnosed with diabetes and have foot ulcers. Each will get a single application of ExpressGraft-C9T1 and its effectiveness will be evaluated over a 12-month period, as well as any reaction to the skin tissue. The study is projected to be completed in May 2019.
But even if ExpressGraft-C9T1 proves to be effective, it is likely to be years before it might be on the market. The product still needs at least two more rounds of testing before Mallinckrodt applies for approval from the U.S. Food and Drug Administration.
If it passes muster, though, the company is hoping ExpressGraft might be used to treat other types of wounds, as well. “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.
StrataGraft, the first skin substitute developed by the former Stratatech, is going through separate human trials. It is in phase 3 testing for treating severe burns.
Stratatech was founded in 2000 based on the discovery in Allen-Hoffmann’s UW-Madison lab of an immortal line of human skin cells that did not die and did not carry viruses or tumors.
Mallinckrodt, based in Staines-Upon-Thames, United Kingdom, bought Stratatech for $76 million in 2016. The company has about 60 employees in Madison at University Research Park.