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The skin graft is produced from 2 types of human skin cells, keratinocytes and dermal fibroblasts.
The US Food and Drug Administration (FDA) has approved an allogeneic cellularized scaffold product (StrataGraft) for the treatment of thermal burns containing intact dermal elements in adult patients.
The approval was granted to Stratatech.
The product is indicated for patients with deep burns, instead of skin replacement using a skin graft which will result in a new wound where skin was removed.
It is produced from 2 types of human skin cells, keratinocytes and dermal fibroblasts. They are grown together to create a bi-layered construct, or cellularized scaffold.
The treatment is a topical application, which is placed onto the burn site by a clinician or healthcare provider.
Over time, the skin cells are expected to grow to replace the skin cells lost from the burn.
The treatment is expected to avoid or decrease the amount of healthy skin necessary for the grafting process.
In addition, the efficacy and safety of the treatment are based on 2 randomized clinical studies, containing 101 adult patients with deep partial-thickness thermal burns.
Both studies identified 2 deep partial thickness burn wounds of equivalent area and depth on each patient and were randomized to receive a single topical application of the cellularized scaffold product or autograft.
The trial noted effectiveness by the percentage of treatment sites that achieved complete wound closure, as well as a significantly decreased need for autografts at the product’s treatment sites.
Further, the adverse effects profile reported by patients in clinical studies included pruritus, blisters, hypertrophic scar, and impaired healing at treatment site.
Safety profiles were noted to be similar to autografting in the study, including wound-related events such as erythema, swelling, local warmth, and wound site injections.
It was noted that since human keratinocyte cells were grown with mouse cells in initial stages of development, the product is considered to be xenotransplantation product.
While mouse cells are reported to no longer be used in the manufacturing process, there is a risk of transmission of infectious diseases or agents, despite not having been reported.
Peter Marks, MD, PhD, director of FDA Center for Biologics Evaluation and Research noted in a statement that serious burns can be extremely difficult to treat, with adverse events affecting more than just 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," Marks said. "This approval provides health care professionals a novel way to treat burn wounds."
The FDA had previously granted the product regenerative medicine advanced therapy (RMAT), Priority Review and Orphan Drug designations.