The approval enables StrataGraft to treat adults with thermal burns containing intact dermal elements
Mallinckrodt has secured approval from the US Food and Drug Administration (FDA) for its viable, bioengineered, allogeneic and cellularised scaffold product called StrataGraft.
StrataGraft, which is derived from keratinocytes grown on gelled collagen containing dermal fibroblasts, is approved to treat adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).
The FDA approval is based on data from the pivotal phase 3 STRATA2016 clinical trial of a single application of StrataGraft in patients with acute thermal burns containing intact dermal elements with total body surface area between 3% and 37%.
According to the company, clinical trials showed that the safety profile of StrataGraft with regard to wound-related events, including erythema, swelling, local warmth and wound site infections, was comparable to that of autografting in clinical studies.
Mallinckrodt has developed StrataGraft to provide viable cells to support the body’s own ability to heal. It consists of metabolically active cells that generate and secrete different growth factors and cytokines.
Both dermal and epidermal layers with well-characterised human cells have been used to design StrataGraft.
The scaffold product is suitable for use in appropriate aseptic conditions such as the operating room, and can be sutured, stapled or secured with a tissue adhesive.
Mallinckrodt executive vice president and chief scientific officer Dr Steven Romano said: “Today’s FDA approval of StrataGraft marks a significant milestone for the burn care community and underscores our unwavering commitment and ability to bring paradigm-changing treatment options to patients with severe and critical conditions.
“We are deeply appreciative of the patients who participated in the StrataGraft clinical trials, the physicians and study investigators involved in the clinical development program, and our employees, who have worked tirelessly over the last 20 years to help us bring StrataGraft to burn surgeons and the patients they treat.”
At present, the firm is carrying out a StrataGraft continued access clinical trial under an Expanded Access Programme (EAP).
The firm also intends to assess StrataGraft to treat adults with full-thickness burns. In addition, it aims to carry out a study assessing StrataGraft to treat paediatric populations.