StrataGraft Cellularized Scaffold Approved for Treatment of Deep Partial Thickness Burns


The allogeneic, cellularized scaffold product helps support autologous skin tissue regeneration in patients with thermal burns requiring surgical intervention.

The FDA has approved StrataGraft, a topical, allogeneic, cellularized scaffold product indicated for the treatment of adults with thermal burns with intact dermal elements who require surgical intervention. The bi-layered, human cell-derived product previously received regenerative medicine advanced therapy, priority review, and orphan drug designations.1

Produced from 2 types of human skin cells, keratinoctyes and dermal fibroblasts, StrataGraft is intended to help avoid or reduce the need for autografting in patients with deep partial thickness burns, as this process creates a new wound and puts the patient at additional risk for complications and infection.

The approval was based on data from 2 trials, one of which was the pivotal phase 3 STRATA2016 clinical trial (NCT03005106) which evaluated the safety and efficacy of StrataGraft in 71 adult patients with 3% to 49% total body surface area thermal burns.2 In each patient, 2 areas of similar depth were randomized to be treated with either StrataGraft or autograft. Co-primary end points were the percentage of StrataGraft sites achieving durable wound closure at 3 months without autograft placement, and the percent area of StrataGraft versus autograft sites that are autografted at 3 months.

At the end of the assessment period, investigators reported a 96% reduction in mean percent area of sites treated with StrataGraft that required autografting (4.3% vs 102.1% of autograft treatment sites; P <.0001). In addition, 83% of patients treated with StrataGraft showed durable wound closure at 3 months without additional autograft placement compared with 86% of patients’ autograft control treatment sites. The most common treatment-related adverse effect was pruritis, reported in 15% of patients, followed by blisters, hypertrophic scar, and impaired healing. No reports of rejection were recorded.2

“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, in a statement.1 “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.”

Notably, StrataGraft is officially categorized by the FDA as a xenotransplantation product as both human and mouse cells were used during initial product development.3 While mouse cells are no longer used in the final manufacturing process, the FDA has warned that there may be a risk of transmission of infectious diseases or agents. No such reports have been filed thus far.

1. Mallinckrodt Announces U.S. FDA Approval of StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat). News release. Mallinckrodt. June 15, 2021.
2. Gibson ALF, Holmes JH, Shupp JW, et al. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft® construct in patients with deep partial-thickness thermal burns. Burns. Published online April 2021. doi:10.1016/j.burns.2021.04.021
3. FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns. News release. US FDA. June 15, 2021.
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