Mallinckrodt announces the FDA approval of StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adults with thermal burns.
The FDA has approved StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in marine collagen – dsat; Mallinckrodt) for the treatment of thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns) in adults.1
This approval makes StrataGraft the first approved donor site-free substitute to autograft for deep partial-thickness burns. StrataGraft is designed to handle like an autograft and promote the body’s healing process to achieve definitive closure of a majority of treated wounds, according to a press release.
While autografting is effective in providing closure of the original wound in patients with deep partial-thickness burns, it can lead to donor site complications, including pain, itching, increased risk of infection, and scarring," said Tracee Short, MD, burn surgeon and burn unit medical director at the Regional Burn Center at Baton Rouge General, Baton Rouge, Louisiana. "The approval of StrataGraft represents an important advancement in the treatment of patients with deep partial-thickness burns. Burn surgeons will now have a new biologic treatment to eliminate or reduce the need for autografting.
The approval is backed by positive data from a phase 3 clinical trial, STRATA2016 (NCT03005106), investigating a single application of StrataGraft in patients with acute thermal burns containing intact dermal elements involving 3-37% of the total body surface area (BSA).
Results demonstrated significantly smaller area of burn wounds treated with StrataGraft required autografting by 3 months vs the area of burn wounds treated exclusively with autograft (p < .0001), according to the release.
Of the 71 StrataGraft-treated burn sites across all participants, 68 (96%) did not require autografting. Also, researchers found the difference in the percent area of StrataGraft and control autograft treatment sites that required autografting by 3 months was 98% (p < .0001). Patients who achieved durable closure of the StrataGraft treatment site at 3 months without autograft placement was 83% (95% CI: 74, 92). Additionally, patients who achieved durable closure of the autograft control treatment site at 3 months without additional autograft placement was 86% (95% CI: 78, 94).1
The safety profile of StrataGraft consisted of erythema, swelling, local warmth and wound site infections, and was comparable to autografting in clinical studies. The most common (>2%) adverse reactions (AEs) were pruritus, blisters, hypertrophic scarring, and impaired healing. Also, there were no reports of rejection to StrataGraft and no patients discontinued due to adverse reactions.
"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," said Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt. "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."
Mallinckrodt plans on evaluating StrataGraft in pediatric populations and in adults with full-thickness burns (third-degree burns).
1. plc M. Mallinckrodt announces u. S. Fda approval of stratagraft (Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat). Accessed June 16, 2021. https://www.prnewswire.com/news-releases/mallinckrodt-announces-us-fda-approval-of-stratagraft-allogeneic-cultured-keratinocytes-and-dermal-fibroblasts-in-murine-collagen---dsat-301313193.html