The US FDA has approved a novel regenerative therapy that could be an alternative to autografting for treating adults with severe burns. The new treatment, StrataGraft, is a bilayer tissue-engineered to mimic the epidermal and dermal layers of the human skin and act as a scaffold for a burn patient’s own skin cells to grow and heal.
The approval was based on the results of two randomized clinical trials (NCT01437852 and NCT03005106) that demonstrated the effectiveness and safety of StrataGraft in 101 adult patients with deep partial thickness thermal burns. These are burns caused by contact with an external heat source such as steam that results in damage throughout the epidermis and dermis.
Source: FDA