FDA approval is supported by data from the pivotal phase III STRATA2016 clinical trial of a single application of StrataGraft in patients with acute thermal burns containing intact dermal elements (deep partial-thickness burns) involving 3% to 37% total body surface area. The trial was conducted at U.S. burn centers.
Results of the pivotal phase III clinical trial, recently published in the journal Burns, demonstrated that a substantially smaller area of burn wounds treated with StrataGraft required autografting by 3 months compared with the area of burn wounds treated exclusively with autograft (P <.0001). In the trial, 96% (68 of 71) of StrataGraft-treated burn sites across all participants did not require autografting. The difference in the percent area of StrataGraft and control autograft treatment sites requiring autografting by 3 months was 98% (P <.0001). The percentage of patients achieving durable closure of the StrataGraft treatment site at 3 months without autograft placement was 83% (95% CI: 74, 92). The percentage of patients achieving durable closure of the autograft control treatment site at 3 months without additional autograft placement was 86% (95% CI: 78, 94).
Common adverse effects reported by patients who received StrataGraft in clinical studies were pruritus, blisters, hypertrophic scar, and impaired healing at the treatment site. Generally, the safety profile of StrataGraft regarding wound-related events, included erythema, swelling, local warmth, and wound-site infections, was comparable to that of autografting in these studies.There were no reports of rejection of StrataGraft in the clinical studies. The FDA granted StrataGraft regenerative medicine advanced therapy, Priority Review, and Orphan Drug designations for this indication.
In the press release, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, stated, “Serious burns can be an incredibly difficult injury to treat and can adversely affect more than just the skin. The goal of burn management is to help the patient return to the highest level of functionality and independence possible, while improving the overall quality of life. This approval provides health care professionals with a novel way to treat burn wounds.”
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