Stratatech said this week that the first patient has been enrolled in a Phase 3 clinical trial of the cell-based regenerative skin tissue the company is developing.
The aim of the study is to assess the safety and efficacy of StrataGraft, the company’s flagship skin replacement product, at coaxing the bodies of patients with burn wounds into regenerating their own skin.
Madison, WI-based Stratatech is owned by the U.K. pharmaceuticals giant Mallinckrodt (NYSE: MNK), which acquired Stratatech a year ago for $76 million in cash, plus potential future milestone payments.
Stratatech estimates it will enroll 70 patients in the study, which is estimated to be completed in late 2019, according to trial information posted on ClinicalTrials.gov.
“We are very excited to further study StrataGraft to learn how it could meet the needs of patients,” said lead investigator James Holmes IV in a prepared statement. Holmes is a surgeon who directs the burn center at Wake Forest Baptist Medical Center, one of the clinical trial sites.
StrataGraft is a sheet of living tissue made from a type of human keratinocyte progenitor cells that develop into skin. According to Stratatech, StrataGraft tissue can be sutured, stapled, or put into place using an adhesive.
The study will include patients who have suffered burns leading to complex skin defects that cover between 3 and 49 percent of their bodies, according to a press release. With these injuries, the entire epidermis (the outermost skin layer) and at least two-thirds of the dermis tissue layer below the epidermis are destroyed. Still, some elements of the dermis remain intact for these particular patients, Stratatech said.
Traditionally, patients with deep partial-thickness burns are treated with an autograft, a procedure in which tissue from another part of a patient’s body is surgically removed and grafted onto the wounded area.
The clinical trial will compare burn sites on the body treated with StrataGraft to sites treated with an autograft. Three months after a patient is treated with StrataGraft, investigators will measure the proportion of the treatment site that still requires a subsequent autograft. Researchers will also measure the number of patients whose wounds were successfully closed by StrataGraft after three months without needing an autograft.
Last month, Stratatech announced that it had enrolled the first patient in a Phase 2 clinical trial of StrataGraft. That study is focused on treating patients with third-degree burns. It’s estimated to enroll 20 patients, and to be completed by October 2018. Investigators will take the same post-treatment measurements as in the Phase 3 study.
Mallinckrodt spokeswoman Rhonda Sciarra said in an e-mail that the company anticipates an approval decision from the FDA on StrataGraft by 2020.
Lynn Allen-Hoffman, who founded Stratatech in 2000 and is now senior vice president of regenerative medicine at Mallinckrodt, said the Phase 3 clinical trial of StrataGraft is part of a multiyear agreement between Stratatech and the Biomedical Advanced Research and Development Authority (BARDA). The two sides first signed a contract in 2013, then extended the agreement in 2015 for an additional five years. BARDA is housed within the U.S. Department of Health and Human Services and is part of a government defense network preparing for the possibility of mass casualties due to terrorist attacks.