Mallinckrodt’s treatment made of artificial skin tissue called Stratagraft closed over 80% of second-degree burn wounds in a phase III trial, matching the effectiveness of skin grafts.
Mallinckrodt recruited 71 patients with second-degree burns who were eligible for skin grafts into the trial. Each patient received the artificial skin graft on some areas of burned skin, and a regular skin graft on others as a control. Three months later, the artificial skin closed 83% of the burn wounds, which was as effective as the 86% of burn wounds closed with regular skin grafts. With this evidence in hand, Mallinckrodt plans to apply for FDA approval in 2020.
Mallinckrodt acquired the phase III Stratagraft treatment when it bought the US company Stratatech Corporation in 2016. The off-the-shelf treatment is made by growing skin cells in the lab to form layers of tissue that mimic human skin. The artificial skin is attached to the burn wounds with staples, sutures, or surgical glue.
A recent phase I trial in burns patients showed that Stratagraft eliminated the need for skin grafts, which involve taking healthy skin from a different part of the patient’s body. “The second wound created by removing healthy skin can be associated with complications and can be even more painful than the burn wound itself,” stated James H. Holmes, the co-lead investigator of the phase III trial, and Director of Wake Forest Baptist Medical Center’s Burn Unit, USA.
Multiple companies are developing regenerative medicines to replace the need for donated skin in treating burns. For example, the New Zealander company Upside Biotechnologies aims to take skin cells from the patient and grow them into personalized artificial skin grafts. This would especially help patients who don’t have enough healthy skin to provide a normal graft. Researchers in Spain have also developed a rapid 3D printer that could make human skin graft materials in the future.
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