The Food and Drug Administration (FDA) has approved StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat), a regenerative skin tissue therapy, for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial thickness burns).
StrataGraft is an allogeneic cellularized scaffold product containing metabolically active cells that produce and secrete a variety of growth factors and cytokines, which are known to be involved in wound repair and regeneration. The product does not remain permanently engrafted, but is replaced by the patient’s own cells over time, eliminating or reducing the need for autografting to attain definitive closure of the majority of treated wounds.
The approval was based on data from 2 studies (ClinicalTrials.gov Identifier: NCT03005106 and ClinicalTrials.gov Identifier: NCT01437852) that assessed the efficacy and safety of StrataGraft in a total of 101 adults with deep partial thickness thermal burns. In both studies, patients who had 2 deep partial thickness thermal burn wounds of comparable area and depth were randomly assigned to receive either a single topical application of StrataGraft or autograft.
Findings from the pivotal phase 3 study (N=71) showed that a significant percentage of StrataGraft treatment sites achieved complete wound closure, with 96% (68/71) of the treated burn sites not requiring autografting. The difference in the percent area of StrataGraft and control autograft treatment sites that required autografting by 3 months was 98% (co-primary endpoint; P <.0001).
At 3 months, the proportion of patients achieving durable closure of the StrataGraft treatment site without autograft placement (co-primary endpoint) was 83% (95% CI, 74-92), while the proportion of patients achieving durable closure of the autograft control treatment site without additional autograft placement was 86% (95% CI, 78-94).
As for safety, the most common adverse reactions reported with StrataGraft were pruritus, blisters, hypertrophic scar, and impaired healing. With regard to wound-related events (ie, erythema, swelling, local warmth, wound site infections), the safety profile of StrataGraft was observed to be similar to that of autografting.
StrataGraft was developed in conjunction with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority. The Company will also be investigating StrataGraft for the treatment of adults with full thickness burns, along with treatment in pediatric patients.
- FDA approves StrataGraft for the treatment of adults with thermal burns. [press release]. Silver Spring, MD: US Food and Drug Administration; June 15, 2021.
- StrataGraft® [package insert]. Dublin, Ireland: Mallinckrodt plc; 2021.